Anxiety
Conditions
Keywords
Anxiety, Cognitive bias, Telemedicine
Brief summary
The project aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes.
Detailed description
Approximately 25-30% of the U.S. population will experience anxiety pathology severe enough to qualify for an anxiety disorder diagnosis during their lifetime. Critically, the majority will not receive treatment, creating a serious need to consider alternative approaches to delivering mental health services that can meet needs on a larger scale. Cognitive Bias Modification (CBM) interventions for anxiety hold considerable promise as a way to meet these needs. These programs alter biased ways of thinking, such as selective assignment of threat interpretations, which are known to cause and maintain anxiety. CBM for interpretation bias (CBM-I) has established efficacy when administered via computer in the laboratory, and there is clear evidence for target engagement (i.e., change in interpretations, the identified mechanism). Now, effectiveness needs to be tested in the community, using sufficiently large samples to evaluate key moderators of its effects, including delivery method (computer vs. mobile phone) and the addition of minimal human contact (for those at risk of attrition). Addressing attrition is critical given high rates of drop out for web-based interventions. Via the PI's MindTrails web site (established with the lab's prior NIMH R34MH106770 award), the lab already has the infrastructure to deliver CBM to the public and recruit large anxious samples. Moreover, the PI and Co-I have established infrastructure to do mobile sensing of mood and CBM-I delivery via mobile phones. Thus, the project can respond to NIMH's request for Effectiveness trials that can contribute to advancing the personalization of mental health care. The current proposal aims to compare effectiveness and target engagement of CBM-I delivered via computer vs. mobile phone, and test if adding minimal human contact for participants at risk of dropout improves retention and outcomes. Study 1 will provide a pilot feasibility and user experience test of the CBM-I program on mobile phones. Study 2 will examine the lab's current online, computer-based CBM-I data to help determine empirical indicators of attrition. Study 3 will provide the primary test of moderators of effectiveness. Namely, in Study 3, high anxious participants will be randomized to one of 2 conditions: 1) CBM-I training delivered by computer or mobile phone (at existing MindTrails site); 2) Alternate intervention group-Psychoeducation only. CBM-I and Psychoeducation conditions include 5 weekly training sessions. Based on theoretically- and empirically-derived predictors of attrition, participants identified as high-risk for dropout in condition 1 will then be randomly assigned to add minimal human contact (using a modified TeleCoach protocol) or no change. Using this adaptive intervention, known as Sequential, Multiple Assignment, Randomized Trial (SMART), the project can test both the effects of CBM-I delivery method and the added value of human contact to improve retention for participants at high-risk for dropping out.
Interventions
BEHAVIORALCognitive Bias Modification - Interpretation training
Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
BEHAVIORALCoaching
Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
BEHAVIORALOnline psychoeducation about anxiety
Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Participants will be aware whether they are completing the intervention by phone or computer, and will know if they are receiving coaching or not.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and over * Moderate to extremely severe anxiety range (i.e., 10 or higher) on the Depression, Anxiety, Stress Scales - Short Form: Anxiety Subscale * Regular access to the Internet via Smartphone or computer
Exclusion criteria
• None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Recognition Ratings (Positive Interpretation Bias) | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias. |
| Change in Recognition Ratings (Negative Interpretation Bias) | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias. |
| Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias. |
| Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias. |
| Change in Overall Anxiety Severity and Impairment Scale | Baseline, and after sessions 1,2, 3, 4, 5 (sessions will be spaced ~1 week apart) & at 2-month follow-up (~2 months after session 5). Session 1 occurs ~0-7 days after baseline. Measure will be completed immediately following that day's training session. | This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below. |
| Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility. Participants are asked I often look at a situation from different viewpoints. with response options as follows, with higher scores indicating more cognitive flexibility (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer |
| Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance. Participants are asked I am willing to fully experience whatever thoughts, feelings, and sensations come up for me, without trying to change them. with response options as follows, with higher scores indicating less avoidance (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer |
| Change in Depression Comorbid Symptoms | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia. A score of 3 or higher on the Patient Health Questionnaire-2 (PHQ-2) is considered an indication of major depressive disorder. The PHQ-2 is a two-question screening tool that asks how often a person has experienced depressed mood or anhedonia over the past two weeks. The score range is 0-6, with higher scores indicating more frequent symptoms, and response options 0-3 for each question where 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day. |
| Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Items 1 and 7 from the Intolerance of Uncertainty Scale-Short Form (IUS-12) will be administered to measure intolerance of uncertainty. Item range = 1 to 7. Total range for aggregated 2 items = 2-14, with a higher score indicating more intolerance of uncertainty. |
| Change in Anxiety and Identity Circles | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | We will assess change in the extent anxiety is viewed as central to the person's self-concept. Participants are asked To what extent is your anxiety a central part of who you are currently? and provided with 5 images of two circles, one labeled My Anxiety and one labeled Me, where the circles start off not touching at all and get increasingly closer/overlapped, with the last image having the circles fully overlapped. We code these 5 images as 0 = No overlap, 1 = overlapped about 25%, 2 = overlapped about 50%, 3 = overlapped about 75%, 4 = Fully overlapped; higher scores indicate that anxiety is more central to the person's self-concept, and lower scores indicate that the person does not identify themself with their anxiety. |
| Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal. Participants are given two statements - When I want to feel more positive emotion, I change the way I'm thinking about the situation and When I want to feel less negative emotion, I change the way I'm thinking about the situation - with response options as follows, with higher scores indicating more reappraisal (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer Total aggregate scores can range from 0 to 7 by taking the mean of the two items. We calculate participants' Cognitive reappraisal scores by taking the mean of the two items, and we are reporting these mean Cognitive reappraisal scores below. |
| Change in Alcohol Use Comorbid Symptoms | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder). |
| Change in Wellness Measures - Optimism | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) assess generalized optimism versus pessimism. Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores range from 0 to 4 by taking the mean of the 2 items. Higher scores indicate lower optimism/higher pessimism. We calculate participants' optimism scores by taking the mean of the two items, and we are reporting these mean optimism scores below. Questions are: If something can go wrong with me, it will. I hardly ever expect things to go my way. |
| Change in Wellness Measures - Growth Mindset | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Items 1, 5, and 7 from the Growth Mindset Measure were administered to measure changes in thinking styles (altered from the original items that reference intelligence). Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate a lack of a growth mindset (AKA more negative outcome). We calculate participants' growth mindset scores by taking the mean of the two items, and we are reporting these mean growth mindset scores below. Questions are: You can learn new things, but you can't really change how you think. No matter how much you have been thinking a particular way, you can always change it quite a bit. You can always substantially change how you think. |
| Change in Wellness Measures - Self-efficacy | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Items 2, 6, and 7 from the New General Self-Efficacy Scale (NGSES) will be administered to measure self-efficacy. Item range = 0 to 4. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate more self-efficacy. We calculate participants' self-efficacy scores by taking the mean of the 3 items. |
| Change in Wellness Measures - Life Satisfaction | Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session. | Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life. Participants are asked All things considered, how satisfied are you with your life as a whole? and can choose from the following options, with lower scores being more dissatisfied with life (AKA more negative): 0 (Completely dissatisfied) 1 2 3 4 5 6 7 8 9 10 (Completely satisfied) Prefer not to answer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition This group started treatment (and had been randomized to CBM-I) but did not complete Session 1 of CBM-I training plus assessments, so was not classified as high/low risk for attrition and thus not randomized for Stage 2 of SMART design | 148 |
| Received CBM-I and Classified Low Attrition Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario. | 288 |
| Received CBM-I and Classified High Attrition and no Coach Given Computer- or phone-based Cognitive Bias Modification - Interpretation training
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario. | 263 |
| Received CBM-I and Classified High Attrition and Given a Coach Computer- or phone-based Cognitive Bias Modification - Interpretation training + Coaching
Cognitive Bias Modification - Interpretation training: Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
Coaching: Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training. | 281 |
| Psychoeducation Online psychoeducation about anxiety
Online psychoeducation about anxiety: Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety. | 241 |
| Psychoeducation, Lacking Classification Measures This group started treatment (and had been Stage 1 randomized to psychoeducation) but did not complete Session 1 of psychoeducation plus assessments, so is not part of the classification measure completer sample | 13 |
| Not Randomized to Treatment Completed consent but didn't complete baseline assessments or reach point of Stage 1 randomization to a treatment arm | 0 |
| Removed From Analyses 5 participants were removed from analyses as there were concerns with the integrity of their data | 5 |
| Total | 1,239 |
Baseline characteristics
| Characteristic | Received CBM-I and Not Classified as High/Low Risk for Attrition | Received CBM-I and Classified Low Attrition | Received CBM-I and Classified High Attrition and no Coach Given | Received CBM-I and Classified High Attrition and Given a Coach | Psychoeducation | Psychoeducation, Lacking Classification Measures | Removed From Analyses | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.16 years STANDARD_DEVIATION 12.09 | 37.2 years STANDARD_DEVIATION 12.33 | 34.24 years STANDARD_DEVIATION 11.13 | 34.37 years STANDARD_DEVIATION 11.9 | 35.09 years STANDARD_DEVIATION 12.3 | 31.54 years STANDARD_DEVIATION 10.44 | 28.50 years STANDARD_DEVIATION 3.32 | 35.09 years STANDARD_DEVIATION 11.97 |
| Country Australia | 4 Participants | 17 Participants | 8 Participants | 10 Participants | 12 Participants | 1 Participants | 0 Participants | 52 Participants |
| Country Canada | 3 Participants | 4 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 12 Participants |
| Country Other | 4 Participants | 7 Participants | 2 Participants | 11 Participants | 7 Participants | 0 Participants | 1 Participants | 32 Participants |
| Country Prefer not to answer | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Country United Kingdom | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 13 Participants |
| Country United States | 133 Participants | 256 Participants | 251 Participants | 259 Participants | 214 Participants | 12 Participants | 2 Participants | 1127 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 22 Participants | 40 Participants | 31 Participants | 38 Participants | 30 Participants | 3 Participants | 0 Participants | 164 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 118 Participants | 230 Participants | 224 Participants | 236 Participants | 201 Participants | 10 Participants | 2 Participants | 1021 Participants |
| Race/Ethnicity, Customized Ethnicity Prefer not to answer | 5 Participants | 11 Participants | 4 Participants | 2 Participants | 8 Participants | 0 Participants | 2 Participants | 32 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 3 Participants | 7 Participants | 4 Participants | 5 Participants | 2 Participants | 0 Participants | 1 Participants | 22 Participants |
| Race/Ethnicity, Customized Race American Indian/Alaska Native | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Black/African origin | 12 Participants | 31 Participants | 27 Participants | 19 Participants | 31 Participants | 2 Participants | 0 Participants | 122 Participants |
| Race/Ethnicity, Customized Race East Asian | 4 Participants | 5 Participants | 7 Participants | 11 Participants | 9 Participants | 0 Participants | 1 Participants | 37 Participants |
| Race/Ethnicity, Customized Race More than one race | 18 Participants | 18 Participants | 22 Participants | 24 Participants | 5 Participants | 0 Participants | 0 Participants | 87 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian/Pacific Islander | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Other or Unknown | 12 Participants | 10 Participants | 10 Participants | 6 Participants | 4 Participants | 1 Participants | 0 Participants | 43 Participants |
| Race/Ethnicity, Customized Race Prefer not to answer | 2 Participants | 4 Participants | 2 Participants | 3 Participants | 5 Participants | 0 Participants | 1 Participants | 17 Participants |
| Race/Ethnicity, Customized Race South Asian | 3 Participants | 4 Participants | 6 Participants | 5 Participants | 7 Participants | 2 Participants | 2 Participants | 29 Participants |
| Race/Ethnicity, Customized Race White/European origin | 95 Participants | 211 Participants | 185 Participants | 212 Participants | 179 Participants | 8 Participants | 1 Participants | 891 Participants |
| Sex/Gender, Customized Female | 112 Participants | 237 Participants | 217 Participants | 231 Participants | 194 Participants | 11 Participants | 1 Participants | 1003 Participants |
| Sex/Gender, Customized Male | 33 Participants | 45 Participants | 38 Participants | 43 Participants | 41 Participants | 2 Participants | 3 Participants | 205 Participants |
| Sex/Gender, Customized Other | 2 Participants | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 16 Participants |
| Sex/Gender, Customized Prefer not to answer | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 6 Participants |
| Sex/Gender, Customized Transgender | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Sex/Gender, Customized Transgender Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender Male | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 288 | 0 / 265 | 0 / 282 | 0 / 242 | 0 / 13 | 0 / 509 |
| other Total, other adverse events | 0 / 149 | 0 / 288 | 0 / 265 | 0 / 282 | 0 / 242 | 0 / 13 | 0 / 509 |
| serious Total, serious adverse events | 0 / 149 | 0 / 288 | 0 / 265 | 0 / 282 | 0 / 242 | 0 / 13 | 0 / 509 |
Outcome results
Primary
Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias)
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the threat-unrelated ratings as an index of benign interpretation bias. Higher scores represent a more benign interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline assessment | 2.04 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 3 assessment | 2.25 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 5 assessment | 2.34 units on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Follow-up assessment | 2.31 units on a scale | Standard Deviation 0.56 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline assessment | 2.00 units on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Follow-up assessment | 2.35 units on a scale | Standard Deviation 0.58 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 5 assessment | 2.51 units on a scale | Standard Deviation 0.52 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 3 assessment | 2.38 units on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline assessment | 2.13 units on a scale | Standard Deviation 0.49 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 5 assessment | 2.45 units on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Follow-up assessment | 2.36 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 3 assessment | 2.36 units on a scale | Standard Deviation 0.52 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline assessment | 2.05 units on a scale | Standard Deviation 0.52 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Follow-up assessment | 2.23 units on a scale | Standard Deviation 0.61 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline assessment | 2.07 units on a scale | Standard Deviation 0.55 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 3 assessment | 2.20 units on a scale | Standard Deviation 0.51 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Session 5 assessment | 2.19 units on a scale | Standard Deviation 0.58 |
| Psychoeducation, Lacking Classification Measures | Change in Brief Bodily Sensations Interpretations Questionnaire (Benign Interpretation Bias) | Baseline assessment | 2.23 units on a scale | Standard Deviation 0.38 |
Comparison: Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation).95% CI: [0.42, 0.54]Mixed Models Analysis
Comparison: Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach).95% CI: [-0.23, 0.39]Mixed Models Analysis
Primary
Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias)
To assess interpretation change, participants are presented with ambiguous events and then asked to rate three alternative explanations for why the event might have occurred on a 5-point scale ranging from 0 to 4. One option is always negative and threat related, whereas the other options are mixed in valence but threat unrelated. We computed the mean of the negative, threat-related ratings as an index of negative interpretation bias. Higher scores represent a more negative interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline assessment | 1.42 units on a scale | Standard Deviation 0.83 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 3 assessment | 0.93 units on a scale | Standard Deviation 0.8 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 5 assessment | 0.81 units on a scale | Standard Deviation 0.68 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Follow-up assessment | 0.78 units on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified Low Attrition | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline assessment | 1.61 units on a scale | Standard Deviation 0.86 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Follow-up assessment | 0.79 units on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 5 assessment | 0.77 units on a scale | Standard Deviation 0.68 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 3 assessment | 0.85 units on a scale | Standard Deviation 0.66 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline assessment | 1.52 units on a scale | Standard Deviation 0.81 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 5 assessment | 0.83 units on a scale | Standard Deviation 0.7 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Follow-up assessment | 0.69 units on a scale | Standard Deviation 0.57 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 3 assessment | 0.85 units on a scale | Standard Deviation 0.71 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline assessment | 1.58 units on a scale | Standard Deviation 0.82 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Follow-up assessment | 1.16 units on a scale | Standard Deviation 0.77 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline assessment | 1.61 units on a scale | Standard Deviation 0.81 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 3 assessment | 1.36 units on a scale | Standard Deviation 0.81 |
| Psychoeducation | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Session 5 assessment | 1.24 units on a scale | Standard Deviation 0.78 |
| Psychoeducation, Lacking Classification Measures | Change in Brief Bodily Sensations Interpretations Questionnaire (Negative Interpretation Bias) | Baseline assessment | 1.35 units on a scale | Standard Deviation 0.94 |
Comparison: Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation).95% CI: [-0.6, -0.51]Mixed Models Analysis
Comparison: Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach).95% CI: [-0.23, 0.27]Mixed Models Analysis
Primary
Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale
This 7-item measure of anxiety symptoms has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 3 (4-point scale). Total DASS-21 anxiety subscale range = 0-21 (multiplied by 2 for DASS-42 = 0-42), with a higher score indicating more severe anxiety symptoms. Average item scores are reported below.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline assessment | 1.61 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified Low Attrition | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 3 assessment | 1.01 units on a scale | Standard Deviation 0.61 |
| Received CBM-I and Classified Low Attrition | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 5 assessment | 0.89 units on a scale | Standard Deviation 0.58 |
| Received CBM-I and Classified Low Attrition | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Follow-up assessment | 0.82 units on a scale | Standard Deviation 0.57 |
| Received CBM-I and Classified Low Attrition | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline assessment | 1.58 units on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Follow-up assessment | 0.80 units on a scale | Standard Deviation 0.63 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 5 assessment | 0.83 units on a scale | Standard Deviation 0.57 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 3 assessment | 0.98 units on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline assessment | 1.65 units on a scale | Standard Deviation 0.54 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 5 assessment | 0.89 units on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Follow-up assessment | 0.80 units on a scale | Standard Deviation 0.64 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 3 assessment | 1.07 units on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline assessment | 1.65 units on a scale | Standard Deviation 0.53 |
| Psychoeducation | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Follow-up assessment | 0.97 units on a scale | Standard Deviation 0.62 |
| Psychoeducation | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline assessment | 1.65 units on a scale | Standard Deviation 0.52 |
| Psychoeducation | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 3 assessment | 1.19 units on a scale | Standard Deviation 0.64 |
| Psychoeducation | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Session 5 assessment | 1.03 units on a scale | Standard Deviation 0.67 |
| Psychoeducation, Lacking Classification Measures | Change in Depression, Anxiety, Stress Scales-Short Form: Anxiety Subscale | Baseline assessment | 1.71 units on a scale | Standard Deviation 0.64 |
Comparison: Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation).95% CI: [-0.39, -0.27]Mixed Models Analysis
Comparison: Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach).95% CI: [-0.14, 0.48]Mixed Models Analysis
Primary
Change in Overall Anxiety Severity and Impairment Scale
This 5-item measure of anxiety symptom severity and impairment has good psychometric properties, shows treatment sensitivity, and is valid in community and clinical samples. Item range = 0 to 4 (5-point scale). Total scale range = 0-20, with a higher score indicating more severe anxiety. Average item scores are reported below.
Time frame: Baseline, and after sessions 1,2, 3, 4, 5 (sessions will be spaced ~1 week apart) & at 2-month follow-up (~2 months after session 5). Session 1 occurs ~0-7 days after baseline. Measure will be completed immediately following that day's training session.
Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Overall Anxiety Severity and Impairment Scale | Baseline assessment | 2.28 units on a scale | Standard Deviation 0.75 |
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Overall Anxiety Severity and Impairment Scale | Session 1 assessment | 2.00 units on a scale | — |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Session 3 assessment | 1.80 units on a scale | Standard Deviation 0.8 |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Baseline assessment | 2.32 units on a scale | Standard Deviation 0.71 |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Session 1 assessment | 2.22 units on a scale | Standard Deviation 0.73 |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Session 2 assessment | 1.75 units on a scale | Standard Deviation 0.74 |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Session 4 assessment | 1.63 units on a scale | Standard Deviation 0.84 |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Session 5 assessment | 1.58 units on a scale | Standard Deviation 0.78 |
| Received CBM-I and Classified Low Attrition | Change in Overall Anxiety Severity and Impairment Scale | Follow-up assessment | 1.59 units on a scale | Standard Deviation 0.79 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Session 1 assessment | 2.15 units on a scale | Standard Deviation 0.75 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Session 2 assessment | 1.71 units on a scale | Standard Deviation 0.74 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Baseline assessment | 2.31 units on a scale | Standard Deviation 0.67 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Session 3 assessment | 1.72 units on a scale | Standard Deviation 0.79 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Follow-up assessment | 1.56 units on a scale | Standard Deviation 0.87 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Session 4 assessment | 1.48 units on a scale | Standard Deviation 0.8 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Overall Anxiety Severity and Impairment Scale | Session 5 assessment | 1.50 units on a scale | Standard Deviation 0.78 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Follow-up assessment | 1.60 units on a scale | Standard Deviation 0.79 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Session 1 assessment | 2.21 units on a scale | Standard Deviation 0.72 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Session 3 assessment | 1.84 units on a scale | Standard Deviation 0.74 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Session 4 assessment | 1.53 units on a scale | Standard Deviation 0.78 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Session 5 assessment | 1.62 units on a scale | Standard Deviation 0.8 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Session 2 assessment | 1.79 units on a scale | Standard Deviation 0.75 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Overall Anxiety Severity and Impairment Scale | Baseline assessment | 2.34 units on a scale | Standard Deviation 0.67 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Baseline assessment | 2.31 units on a scale | Standard Deviation 0.68 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Session 3 assessment | 2.00 units on a scale | Standard Deviation 0.78 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Session 5 assessment | 1.77 units on a scale | Standard Deviation 0.85 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Session 4 assessment | 1.85 units on a scale | Standard Deviation 0.9 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Session 1 assessment | 2.24 units on a scale | Standard Deviation 0.73 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Follow-up assessment | 1.68 units on a scale | Standard Deviation 0.81 |
| Psychoeducation | Change in Overall Anxiety Severity and Impairment Scale | Session 2 assessment | 1.92 units on a scale | Standard Deviation 0.75 |
| Psychoeducation, Lacking Classification Measures | Change in Overall Anxiety Severity and Impairment Scale | Baseline assessment | 2.62 units on a scale | Standard Deviation 0.79 |
Comparison: Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation).95% CI: [-0.46, -0.37]Mixed Models Analysis
Comparison: Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach).95% CI: [-0.23, 0.32]Mixed Models Analysis
Primary
Change in Recognition Ratings (Negative Interpretation Bias)
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the negative, threat-related ratings index negative interpretation bias. Higher scores represent a more negative interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Recognition Ratings (Negative Interpretation Bias) | Baseline assessment | 2.78 units on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Negative Interpretation Bias) | Session 5 assessment | 2.58 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Negative Interpretation Bias) | Baseline assessment | 2.90 units on a scale | Standard Deviation 0.54 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Negative Interpretation Bias) | Follow-up assessment | 2.55 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Negative Interpretation Bias) | Session 3 assessment | 2.56 units on a scale | Standard Deviation 0.56 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Negative Interpretation Bias) | Follow-up assessment | 2.48 units on a scale | Standard Deviation 0.56 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Negative Interpretation Bias) | Baseline assessment | 2.96 units on a scale | Standard Deviation 0.51 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Negative Interpretation Bias) | Session 3 assessment | 2.49 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Negative Interpretation Bias) | Session 5 assessment | 2.53 units on a scale | Standard Deviation 0.56 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Negative Interpretation Bias) | Follow-up assessment | 2.43 units on a scale | Standard Deviation 0.58 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Negative Interpretation Bias) | Baseline assessment | 2.94 units on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Negative Interpretation Bias) | Session 3 assessment | 2.46 units on a scale | Standard Deviation 0.58 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Negative Interpretation Bias) | Session 5 assessment | 2.56 units on a scale | Standard Deviation 0.52 |
| Psychoeducation | Change in Recognition Ratings (Negative Interpretation Bias) | Session 5 assessment | 2.74 units on a scale | Standard Deviation 0.59 |
| Psychoeducation | Change in Recognition Ratings (Negative Interpretation Bias) | Session 3 assessment | 2.87 units on a scale | Standard Deviation 0.55 |
| Psychoeducation | Change in Recognition Ratings (Negative Interpretation Bias) | Follow-up assessment | 2.68 units on a scale | Standard Deviation 0.58 |
| Psychoeducation | Change in Recognition Ratings (Negative Interpretation Bias) | Baseline assessment | 2.89 units on a scale | Standard Deviation 0.5 |
| Psychoeducation, Lacking Classification Measures | Change in Recognition Ratings (Negative Interpretation Bias) | Baseline assessment | 2.70 units on a scale | Standard Deviation 0.6 |
Comparison: Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation).95% CI: [-0.69, -0.57]Mixed Models Analysis
Comparison: Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach).95% CI: [-0.26, 0.39]Mixed Models Analysis
Primary
Change in Recognition Ratings (Positive Interpretation Bias)
To measure interpretation bias, participants will read ambiguous scenarios with titles, after which they will see the titles of each scenario, followed by 4 interpretations of the scenario: 1 positive and threat related, 1 negative and threat related, 1 positive and threat unrelated, and 1 negative and threat unrelated. Participants will rate each interpretation based on how similar in meaning it is to the original scenario on a 4-point scale ranging from 1 to 4. The mean of the positive, threat-related ratings index positive interpretation bias. Higher scores represent a more positive interpretation bias.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: A few participants were excluded from analyses during data cleaning due to concerns about integrity of their data, hence the # of analyzed participants is slightly below the enrollment #.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Recognition Ratings (Positive Interpretation Bias) | Baseline assessment | 2.40 units on a scale | Standard Deviation 0.47 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Positive Interpretation Bias) | Session 3 assessment | 2.89 units on a scale | Standard Deviation 0.44 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Positive Interpretation Bias) | Session 5 assessment | 2.83 units on a scale | Standard Deviation 0.52 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Positive Interpretation Bias) | Follow-up assessment | 2.71 units on a scale | Standard Deviation 0.47 |
| Received CBM-I and Classified Low Attrition | Change in Recognition Ratings (Positive Interpretation Bias) | Baseline assessment | 2.29 units on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Positive Interpretation Bias) | Follow-up assessment | 2.80 units on a scale | Standard Deviation 0.46 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Positive Interpretation Bias) | Session 5 assessment | 2.92 units on a scale | Standard Deviation 0.44 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Positive Interpretation Bias) | Session 3 assessment | 2.84 units on a scale | Standard Deviation 0.48 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Recognition Ratings (Positive Interpretation Bias) | Baseline assessment | 2.29 units on a scale | Standard Deviation 0.54 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Positive Interpretation Bias) | Session 5 assessment | 2.86 units on a scale | Standard Deviation 0.5 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Positive Interpretation Bias) | Follow-up assessment | 2.75 units on a scale | Standard Deviation 0.54 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Positive Interpretation Bias) | Session 3 assessment | 2.92 units on a scale | Standard Deviation 0.49 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Recognition Ratings (Positive Interpretation Bias) | Baseline assessment | 2.30 units on a scale | Standard Deviation 0.53 |
| Psychoeducation | Change in Recognition Ratings (Positive Interpretation Bias) | Follow-up assessment | 2.48 units on a scale | Standard Deviation 0.53 |
| Psychoeducation | Change in Recognition Ratings (Positive Interpretation Bias) | Baseline assessment | 2.33 units on a scale | Standard Deviation 0.54 |
| Psychoeducation | Change in Recognition Ratings (Positive Interpretation Bias) | Session 3 assessment | 2.39 units on a scale | Standard Deviation 0.57 |
| Psychoeducation | Change in Recognition Ratings (Positive Interpretation Bias) | Session 5 assessment | 2.42 units on a scale | Standard Deviation 0.55 |
| Psychoeducation, Lacking Classification Measures | Change in Recognition Ratings (Positive Interpretation Bias) | Baseline assessment | 2.40 units on a scale | Standard Deviation 0.6 |
Comparison: Intent-to-treat (ITT) analysis of Stage 1 randomization to CBM-I vs. psychoeducation. To correct for sampling bias (i.e., CBM-I, high attrition, coach received coaching, whereas psychoeducation did not receive coaching), CBM-I, high attrition, coach participants were excluded and replaced with an equal number of CBM-I, high attrition, no coach participants (using bootstrap resampling). The corrected ITT analysis sample included 1,234 participants (980 in CBM-I, 254 in psychoeducation).95% CI: [1.04, 1.16]Mixed Models Analysis
Comparison: Analysis of Stage 2 randomization of CBM-I participants classified as high risk for attrition to supplemental coaching vs. no coaching. The analysis sample included 544 participants (263 in CBM-I, high attrition, no coach; 281 in CBM-I, high attrition, coach).95% CI: [-0.43, 0.2]Mixed Models Analysis
Secondary
Change in Alcohol Use Comorbid Symptoms
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) is a 3-item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol use disorders. The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Alcohol Use Comorbid Symptoms | Baseline | 0.92 score on a scale | Standard Deviation 0.82 |
| Received CBM-I and Classified Low Attrition | Change in Alcohol Use Comorbid Symptoms | Baseline | 0.90 score on a scale | Standard Deviation 0.84 |
| Received CBM-I and Classified Low Attrition | Change in Alcohol Use Comorbid Symptoms | Session 5 | 0.75 score on a scale | Standard Deviation 0.75 |
| Received CBM-I and Classified Low Attrition | Change in Alcohol Use Comorbid Symptoms | Session 3 | 0.88 score on a scale | Standard Deviation 0.89 |
| Received CBM-I and Classified Low Attrition | Change in Alcohol Use Comorbid Symptoms | 2-month Follow-up | 0.78 score on a scale | Standard Deviation 0.8 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Alcohol Use Comorbid Symptoms | Session 3 | 0.92 score on a scale | Standard Deviation 0.83 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Alcohol Use Comorbid Symptoms | 2-month Follow-up | 0.80 score on a scale | Standard Deviation 0.7 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Alcohol Use Comorbid Symptoms | Baseline | 0.94 score on a scale | Standard Deviation 0.86 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Alcohol Use Comorbid Symptoms | Session 5 | 0.85 score on a scale | Standard Deviation 0.77 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Alcohol Use Comorbid Symptoms | Session 5 | 0.71 score on a scale | Standard Deviation 0.73 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Alcohol Use Comorbid Symptoms | Session 3 | 0.80 score on a scale | Standard Deviation 0.73 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Alcohol Use Comorbid Symptoms | 2-month Follow-up | 0.59 score on a scale | Standard Deviation 0.62 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Alcohol Use Comorbid Symptoms | Baseline | 0.95 score on a scale | Standard Deviation 0.79 |
| Psychoeducation | Change in Alcohol Use Comorbid Symptoms | Baseline | 0.90 score on a scale | Standard Deviation 0.89 |
| Psychoeducation | Change in Alcohol Use Comorbid Symptoms | 2-month Follow-up | 0.71 score on a scale | Standard Deviation 0.8 |
| Psychoeducation | Change in Alcohol Use Comorbid Symptoms | Session 3 | 0.84 score on a scale | Standard Deviation 0.85 |
| Psychoeducation | Change in Alcohol Use Comorbid Symptoms | Session 5 | 0.78 score on a scale | Standard Deviation 0.8 |
| Psychoeducation, Lacking Classification Measures | Change in Alcohol Use Comorbid Symptoms | Baseline | 0.64 score on a scale | Standard Deviation 0.73 |
Secondary
Change in Anxiety and Identity Circles
We will assess change in the extent anxiety is viewed as central to the person's self-concept. Participants are asked To what extent is your anxiety a central part of who you are currently? and provided with 5 images of two circles, one labeled My Anxiety and one labeled Me, where the circles start off not touching at all and get increasingly closer/overlapped, with the last image having the circles fully overlapped. We code these 5 images as 0 = No overlap, 1 = overlapped about 25%, 2 = overlapped about 50%, 3 = overlapped about 75%, 4 = Fully overlapped; higher scores indicate that anxiety is more central to the person's self-concept, and lower scores indicate that the person does not identify themself with their anxiety.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Anxiety and Identity Circles | Baseline | 2.48 score on a scale | Standard Deviation 0.93 |
| Received CBM-I and Classified Low Attrition | Change in Anxiety and Identity Circles | Session 3 | 1.93 score on a scale | Standard Deviation 0.93 |
| Received CBM-I and Classified Low Attrition | Change in Anxiety and Identity Circles | Session 5 | 1.61 score on a scale | Standard Deviation 1 |
| Received CBM-I and Classified Low Attrition | Change in Anxiety and Identity Circles | 2-month Follow-up | 1.57 score on a scale | Standard Deviation 0.88 |
| Received CBM-I and Classified Low Attrition | Change in Anxiety and Identity Circles | Baseline | 2.55 score on a scale | Standard Deviation 0.9 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Anxiety and Identity Circles | 2-month Follow-up | 1.54 score on a scale | Standard Deviation 0.85 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Anxiety and Identity Circles | Session 5 | 1.69 score on a scale | Standard Deviation 0.79 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Anxiety and Identity Circles | Session 3 | 1.86 score on a scale | Standard Deviation 0.92 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Anxiety and Identity Circles | Baseline | 2.51 score on a scale | Standard Deviation 0.88 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Anxiety and Identity Circles | Session 5 | 1.75 score on a scale | Standard Deviation 0.99 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Anxiety and Identity Circles | 2-month Follow-up | 1.57 score on a scale | Standard Deviation 0.89 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Anxiety and Identity Circles | Session 3 | 2.01 score on a scale | Standard Deviation 0.9 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Anxiety and Identity Circles | Baseline | 2.56 score on a scale | Standard Deviation 0.85 |
| Psychoeducation | Change in Anxiety and Identity Circles | 2-month Follow-up | 1.78 score on a scale | Standard Deviation 1.01 |
| Psychoeducation | Change in Anxiety and Identity Circles | Baseline | 2.49 score on a scale | Standard Deviation 0.98 |
| Psychoeducation | Change in Anxiety and Identity Circles | Session 3 | 2.12 score on a scale | Standard Deviation 0.95 |
| Psychoeducation | Change in Anxiety and Identity Circles | Session 5 | 1.83 score on a scale | Standard Deviation 0.94 |
| Psychoeducation, Lacking Classification Measures | Change in Anxiety and Identity Circles | Baseline | 2.42 score on a scale | Standard Deviation 0.79 |
Secondary
Change in Depression Comorbid Symptoms
The Patient Health Questionnaire 2 (PHQ-2) inquires about the frequency of depressed mood and anhedonia. A score of 3 or higher on the Patient Health Questionnaire-2 (PHQ-2) is considered an indication of major depressive disorder. The PHQ-2 is a two-question screening tool that asks how often a person has experienced depressed mood or anhedonia over the past two weeks. The score range is 0-6, with higher scores indicating more frequent symptoms, and response options 0-3 for each question where 0: Not at all, 1: Several days, 2: More than half the days, 3: Nearly every day.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Depression Comorbid Symptoms | Baseline | 2.77 score on a scale | Standard Deviation 0.86 |
| Received CBM-I and Classified Low Attrition | Change in Depression Comorbid Symptoms | Session 3 | 2.35 score on a scale | Standard Deviation 0.92 |
| Received CBM-I and Classified Low Attrition | Change in Depression Comorbid Symptoms | Session 5 | 2.15 score on a scale | Standard Deviation 0.92 |
| Received CBM-I and Classified Low Attrition | Change in Depression Comorbid Symptoms | 2-month Follow-up | 2.15 score on a scale | Standard Deviation 0.91 |
| Received CBM-I and Classified Low Attrition | Change in Depression Comorbid Symptoms | Baseline | 2.76 score on a scale | Standard Deviation 0.9 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression Comorbid Symptoms | 2-month Follow-up | 2.00 score on a scale | Standard Deviation 0.93 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression Comorbid Symptoms | Session 5 | 2.12 score on a scale | Standard Deviation 0.9 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression Comorbid Symptoms | Session 3 | 2.22 score on a scale | Standard Deviation 0.86 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Depression Comorbid Symptoms | Baseline | 2.68 score on a scale | Standard Deviation 0.93 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression Comorbid Symptoms | Session 5 | 2.13 score on a scale | Standard Deviation 0.9 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression Comorbid Symptoms | 2-month Follow-up | 2.00 score on a scale | Standard Deviation 0.89 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression Comorbid Symptoms | Session 3 | 2.32 score on a scale | Standard Deviation 0.9 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Depression Comorbid Symptoms | Baseline | 2.77 score on a scale | Standard Deviation 0.91 |
| Psychoeducation | Change in Depression Comorbid Symptoms | 2-month Follow-up | 2.09 score on a scale | Standard Deviation 0.88 |
| Psychoeducation | Change in Depression Comorbid Symptoms | Baseline | 2.78 score on a scale | Standard Deviation 0.89 |
| Psychoeducation | Change in Depression Comorbid Symptoms | Session 3 | 2.49 score on a scale | Standard Deviation 0.96 |
| Psychoeducation | Change in Depression Comorbid Symptoms | Session 5 | 2.36 score on a scale | Standard Deviation 0.97 |
| Psychoeducation, Lacking Classification Measures | Change in Depression Comorbid Symptoms | Baseline | 2.92 score on a scale | Standard Deviation 0.95 |
Secondary
Change in Mechanisms Underlying Bias Change - Cognitive Flexibility
Item 14 of the Cognitive Flexibility Inventory (CFI) will be administered to measure cognitive flexibility. Participants are asked I often look at a situation from different viewpoints. with response options as follows, with higher scores indicating more cognitive flexibility (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline | 5.20 score on a scale | Standard Deviation 1.41 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 3 | 5.41 score on a scale | Standard Deviation 1.31 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 5 | 5.40 score on a scale | Standard Deviation 1.4 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | 2-month Follow-up | 5.59 score on a scale | Standard Deviation 1.15 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline | 5.20 score on a scale | Standard Deviation 1.43 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | 2-month Follow-up | 5.57 score on a scale | Standard Deviation 1.19 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 5 | 5.61 score on a scale | Standard Deviation 1.35 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 3 | 5.60 score on a scale | Standard Deviation 1.33 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline | 5.25 score on a scale | Standard Deviation 1.38 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 5 | 5.52 score on a scale | Standard Deviation 1.23 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | 2-month Follow-up | 5.57 score on a scale | Standard Deviation 1.2 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 3 | 5.41 score on a scale | Standard Deviation 1.35 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline | 5.17 score on a scale | Standard Deviation 1.51 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | 2-month Follow-up | 5.47 score on a scale | Standard Deviation 1.26 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline | 5.04 score on a scale | Standard Deviation 1.44 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 3 | 5.36 score on a scale | Standard Deviation 1.24 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Session 5 | 5.33 score on a scale | Standard Deviation 1.26 |
| Psychoeducation, Lacking Classification Measures | Change in Mechanisms Underlying Bias Change - Cognitive Flexibility | Baseline | 5.54 score on a scale | Standard Deviation 1.05 |
Secondary
Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal
Items 7 and 10 from the Emotion Regulation Questionnaire (ERQ) will be administered to measure cognitive reappraisal. Participants are given two statements - When I want to feel more positive emotion, I change the way I'm thinking about the situation and When I want to feel less negative emotion, I change the way I'm thinking about the situation - with response options as follows, with higher scores indicating more reappraisal (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer Total aggregate scores can range from 0 to 7 by taking the mean of the two items. We calculate participants' Cognitive reappraisal scores by taking the mean of the two items, and we are reporting these mean Cognitive reappraisal scores below.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline | 4.41 score on a scale | Standard Deviation 1.57 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 3 | 4.90 score on a scale | Standard Deviation 1.25 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 5 | 5.11 score on a scale | Standard Deviation 1.28 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | 2-month Follow-up | 5.00 score on a scale | Standard Deviation 1.2 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline | 4.28 score on a scale | Standard Deviation 1.49 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | 2-month Follow-up | 4.96 score on a scale | Standard Deviation 1.18 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 5 | 4.95 score on a scale | Standard Deviation 1.2 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 3 | 4.81 score on a scale | Standard Deviation 1.44 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline | 4.34 score on a scale | Standard Deviation 1.42 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 5 | 4.89 score on a scale | Standard Deviation 1.32 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | 2-month Follow-up | 5.01 score on a scale | Standard Deviation 1.18 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 3 | 4.79 score on a scale | Standard Deviation 1.28 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline | 4.29 score on a scale | Standard Deviation 1.41 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | 2-month Follow-up | 4.92 score on a scale | Standard Deviation 1.11 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline | 4.14 score on a scale | Standard Deviation 1.36 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 3 | 4.59 score on a scale | Standard Deviation 1.33 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Session 5 | 4.87 score on a scale | Standard Deviation 1.29 |
| Psychoeducation, Lacking Classification Measures | Change in Mechanisms Underlying Bias Change - Cognitive Reappraisal | Baseline | 4.65 score on a scale | Standard Deviation 1.05 |
Secondary
Change in Mechanisms Underlying Bias Change - Experiential Avoidance
Item 11 from the Comprehensive Assessment of ACT processes (CompACT) will be administered to measure experiential avoidance. Participants are asked I am willing to fully experience whatever thoughts, feelings, and sensations come up for me, without trying to change them. with response options as follows, with higher scores indicating less avoidance (AKA more positive outcome): 1. = Strongly disagree 2. = Disagree 3. = Somewhat disagree 4. = Neutral 5. = Somewhat agree 6. = Agree 7. = Strongly agree Prefer not to answer
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline | 4.05 score on a scale | Standard Deviation 1.75 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 3 | 4.33 score on a scale | Standard Deviation 1.6 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 5 | 4.56 score on a scale | Standard Deviation 1.55 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | 2-month Follow-up | 4.58 score on a scale | Standard Deviation 1.51 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline | 3.78 score on a scale | Standard Deviation 1.66 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | 2-month Follow-up | 4.73 score on a scale | Standard Deviation 1.54 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 5 | 4.72 score on a scale | Standard Deviation 1.41 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 3 | 4.44 score on a scale | Standard Deviation 1.6 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline | 3.89 score on a scale | Standard Deviation 1.63 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 5 | 4.43 score on a scale | Standard Deviation 1.56 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | 2-month Follow-up | 4.17 score on a scale | Standard Deviation 1.61 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 3 | 3.94 score on a scale | Standard Deviation 1.57 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline | 3.85 score on a scale | Standard Deviation 1.64 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | 2-month Follow-up | 4.35 score on a scale | Standard Deviation 1.43 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline | 3.80 score on a scale | Standard Deviation 1.55 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 3 | 4.14 score on a scale | Standard Deviation 1.53 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Session 5 | 4.25 score on a scale | Standard Deviation 1.48 |
| Psychoeducation, Lacking Classification Measures | Change in Mechanisms Underlying Bias Change - Experiential Avoidance | Baseline | 3.85 score on a scale | Standard Deviation 1.41 |
Secondary
Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty
Items 1 and 7 from the Intolerance of Uncertainty Scale-Short Form (IUS-12) will be administered to measure intolerance of uncertainty. Item range = 1 to 7. Total range for aggregated 2 items = 2-14, with a higher score indicating more intolerance of uncertainty.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline | 5.42 score on a scale | Standard Deviation 1.27 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline | 5.57 score on a scale | Standard Deviation 1.11 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 5 | 5.00 score on a scale | Standard Deviation 1.37 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 3 | 5.22 score on a scale | Standard Deviation 1.2 |
| Received CBM-I and Classified Low Attrition | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | 2-month Follow-up | 5.10 score on a scale | Standard Deviation 1.31 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline | 5.56 score on a scale | Standard Deviation 1.14 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | 2-month Follow-up | 5.16 score on a scale | Standard Deviation 1.2 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 3 | 5.18 score on a scale | Standard Deviation 1.19 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 5 | 5.08 score on a scale | Standard Deviation 1.14 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 5 | 5.03 score on a scale | Standard Deviation 1.21 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 3 | 5.29 score on a scale | Standard Deviation 1.17 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | 2-month Follow-up | 5.02 score on a scale | Standard Deviation 1.2 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline | 5.65 score on a scale | Standard Deviation 1.12 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline | 5.53 score on a scale | Standard Deviation 1.23 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | 2-month Follow-up | 5.26 score on a scale | Standard Deviation 1.19 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 3 | 5.44 score on a scale | Standard Deviation 1.2 |
| Psychoeducation | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Session 5 | 5.25 score on a scale | Standard Deviation 1.22 |
| Psychoeducation, Lacking Classification Measures | Change in Mechanisms Underlying Bias Change - Intolerance of Uncertainty | Baseline | 5.62 score on a scale | Standard Deviation 1.16 |
Secondary
Change in Wellness Measures - Growth Mindset
Items 1, 5, and 7 from the Growth Mindset Measure were administered to measure changes in thinking styles (altered from the original items that reference intelligence). Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate a lack of a growth mindset (AKA more negative outcome). We calculate participants' growth mindset scores by taking the mean of the two items, and we are reporting these mean growth mindset scores below. Questions are: You can learn new things, but you can't really change how you think. No matter how much you have been thinking a particular way, you can always change it quite a bit. You can always substantially change how you think.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Wellness Measures - Growth Mindset | Baseline | 2.17 score on a scale | Standard Deviation 0.57 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Growth Mindset | Session 3 | 2.29 score on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Growth Mindset | Session 5 | 2.29 score on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Growth Mindset | 2-month Follow-up | 2.22 score on a scale | Standard Deviation 0.47 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Growth Mindset | Baseline | 2.14 score on a scale | Standard Deviation 0.5 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Growth Mindset | 2-month Follow-up | 2.25 score on a scale | Standard Deviation 0.52 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Growth Mindset | Session 5 | 2.34 score on a scale | Standard Deviation 0.51 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Growth Mindset | Session 3 | 2.33 score on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Growth Mindset | Baseline | 2.12 score on a scale | Standard Deviation 0.55 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Growth Mindset | Session 5 | 2.25 score on a scale | Standard Deviation 0.53 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Growth Mindset | 2-month Follow-up | 2.26 score on a scale | Standard Deviation 0.46 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Growth Mindset | Session 3 | 2.27 score on a scale | Standard Deviation 0.47 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Growth Mindset | Baseline | 2.10 score on a scale | Standard Deviation 0.51 |
| Psychoeducation | Change in Wellness Measures - Growth Mindset | 2-month Follow-up | 2.25 score on a scale | Standard Deviation 0.5 |
| Psychoeducation | Change in Wellness Measures - Growth Mindset | Baseline | 2.13 score on a scale | Standard Deviation 0.53 |
| Psychoeducation | Change in Wellness Measures - Growth Mindset | Session 3 | 2.20 score on a scale | Standard Deviation 0.49 |
| Psychoeducation | Change in Wellness Measures - Growth Mindset | Session 5 | 2.28 score on a scale | Standard Deviation 0.52 |
| Psychoeducation, Lacking Classification Measures | Change in Wellness Measures - Growth Mindset | Baseline | 2.13 score on a scale | Standard Deviation 0.44 |
Secondary
Change in Wellness Measures - Life Satisfaction
Single-Item Life Satisfaction measure will be administered to measure overall satisfaction with one's life. Participants are asked All things considered, how satisfied are you with your life as a whole? and can choose from the following options, with lower scores being more dissatisfied with life (AKA more negative): 0 (Completely dissatisfied) 1 2 3 4 5 6 7 8 9 10 (Completely satisfied) Prefer not to answer
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Wellness Measures - Life Satisfaction | Baseline | 4.71 score on a scale | Standard Deviation 2.28 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Life Satisfaction | Session 3 | 5.69 score on a scale | Standard Deviation 2.21 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Life Satisfaction | Baseline | 4.77 score on a scale | Standard Deviation 2.22 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Life Satisfaction | Session 5 | 5.81 score on a scale | Standard Deviation 2.32 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Life Satisfaction | 2-month Follow-up | 5.71 score on a scale | Standard Deviation 2.16 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Life Satisfaction | Baseline | 5.09 score on a scale | Standard Deviation 2.16 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Life Satisfaction | 2-month Follow-up | 6.12 score on a scale | Standard Deviation 2.05 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Life Satisfaction | Session 3 | 5.75 score on a scale | Standard Deviation 2.05 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Life Satisfaction | Session 5 | 6.00 score on a scale | Standard Deviation 2.08 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Life Satisfaction | Baseline | 4.95 score on a scale | Standard Deviation 2.14 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Life Satisfaction | Session 3 | 5.94 score on a scale | Standard Deviation 1.99 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Life Satisfaction | Session 5 | 6.01 score on a scale | Standard Deviation 1.91 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Life Satisfaction | 2-month Follow-up | 6.14 score on a scale | Standard Deviation 2.03 |
| Psychoeducation | Change in Wellness Measures - Life Satisfaction | 2-month Follow-up | 5.76 score on a scale | Standard Deviation 1.91 |
| Psychoeducation | Change in Wellness Measures - Life Satisfaction | Session 5 | 5.79 score on a scale | Standard Deviation 2.05 |
| Psychoeducation | Change in Wellness Measures - Life Satisfaction | Session 3 | 5.28 score on a scale | Standard Deviation 2.13 |
| Psychoeducation | Change in Wellness Measures - Life Satisfaction | Baseline | 5.01 score on a scale | Standard Deviation 2.18 |
| Psychoeducation, Lacking Classification Measures | Change in Wellness Measures - Life Satisfaction | Baseline | 4.31 score on a scale | Standard Deviation 2.5 |
Secondary
Change in Wellness Measures - Optimism
Items 3 and 7 from the Life Orientation Test-Revised (LOT-R) assess generalized optimism versus pessimism. Responses include: 0 = Strongly disagree, 1 = Disagree, 2 = Neutral, 3 = Agree, and 4 = Strongly agree, plus Prefer not to answer. Total aggregate scores range from 0 to 4 by taking the mean of the 2 items. Higher scores indicate lower optimism/higher pessimism. We calculate participants' optimism scores by taking the mean of the two items, and we are reporting these mean optimism scores below. Questions are: If something can go wrong with me, it will. I hardly ever expect things to go my way.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Wellness Measures - Optimism | Baseline | 1.33 score on a scale | Standard Deviation 1 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Optimism | Session 5 | 1.85 score on a scale | Standard Deviation 1.03 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Optimism | Session 3 | 1.82 score on a scale | Standard Deviation 0.94 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Optimism | Baseline | 1.40 score on a scale | Standard Deviation 0.97 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Optimism | 2-month Follow-up | 1.93 score on a scale | Standard Deviation 1.03 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Optimism | 2-month Follow-up | 1.84 score on a scale | Standard Deviation 1.08 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Optimism | Baseline | 1.39 score on a scale | Standard Deviation 0.96 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Optimism | Session 3 | 1.82 score on a scale | Standard Deviation 1.05 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Optimism | Session 5 | 1.97 score on a scale | Standard Deviation 1.06 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Optimism | Session 3 | 1.79 score on a scale | Standard Deviation 1.07 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Optimism | Baseline | 1.45 score on a scale | Standard Deviation 1.02 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Optimism | 2-month Follow-up | 1.95 score on a scale | Standard Deviation 1.07 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Optimism | Session 5 | 1.82 score on a scale | Standard Deviation 1.01 |
| Psychoeducation | Change in Wellness Measures - Optimism | Session 5 | 1.57 score on a scale | Standard Deviation 0.97 |
| Psychoeducation | Change in Wellness Measures - Optimism | Session 3 | 1.52 score on a scale | Standard Deviation 0.98 |
| Psychoeducation | Change in Wellness Measures - Optimism | Baseline | 1.29 score on a scale | Standard Deviation 0.97 |
| Psychoeducation | Change in Wellness Measures - Optimism | 2-month Follow-up | 1.65 score on a scale | Standard Deviation 0.93 |
| Psychoeducation, Lacking Classification Measures | Change in Wellness Measures - Optimism | Baseline | 1.85 score on a scale | Standard Deviation 1.43 |
Secondary
Change in Wellness Measures - Self-efficacy
Items 2, 6, and 7 from the New General Self-Efficacy Scale (NGSES) will be administered to measure self-efficacy. Item range = 0 to 4. Total aggregate scores can range from 0 to 4 by taking the mean of the 3 items. Higher scores indicate more self-efficacy. We calculate participants' self-efficacy scores by taking the mean of the 3 items.
Time frame: Baseline, and after session 3 (2-3 weeks following baseline), session 5 (~2 weeks after session 3), & at 2-month follow-up (~ 2 months after session 5). Measure will be completed immediately following that day's training session.
Population: Some weeks have less participants reported than overall number analyzed because of attrition - participants did not fill out the survey and thus we do not have data to report on all participants across all weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received CBM-I and Not Classified as High/Low Risk for Attrition | Change in Wellness Measures - Self-efficacy | Baseline | 2.27 score on a scale | Standard Deviation 0.93 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Self-efficacy | Session 3 | 2.71 score on a scale | Standard Deviation 0.84 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Self-efficacy | Session 5 | 2.77 score on a scale | Standard Deviation 0.81 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Self-efficacy | 2-month Follow-up | 2.75 score on a scale | Standard Deviation 0.75 |
| Received CBM-I and Classified Low Attrition | Change in Wellness Measures - Self-efficacy | Baseline | 2.27 score on a scale | Standard Deviation 0.92 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Self-efficacy | 2-month Follow-up | 2.82 score on a scale | Standard Deviation 0.74 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Self-efficacy | Session 5 | 2.75 score on a scale | Standard Deviation 0.79 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Self-efficacy | Session 3 | 2.75 score on a scale | Standard Deviation 0.85 |
| Received CBM-I and Classified High Attrition and no Coach Given | Change in Wellness Measures - Self-efficacy | Baseline | 2.37 score on a scale | Standard Deviation 0.83 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Self-efficacy | Session 5 | 2.74 score on a scale | Standard Deviation 0.84 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Self-efficacy | 2-month Follow-up | 2.75 score on a scale | Standard Deviation 0.78 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Self-efficacy | Session 3 | 2.59 score on a scale | Standard Deviation 0.81 |
| Received CBM-I and Classified High Attrition and Given a Coach | Change in Wellness Measures - Self-efficacy | Baseline | 2.22 score on a scale | Standard Deviation 0.93 |
| Psychoeducation | Change in Wellness Measures - Self-efficacy | 2-month Follow-up | 2.58 score on a scale | Standard Deviation 0.8 |
| Psychoeducation | Change in Wellness Measures - Self-efficacy | Baseline | 2.20 score on a scale | Standard Deviation 0.93 |
| Psychoeducation | Change in Wellness Measures - Self-efficacy | Session 3 | 2.41 score on a scale | Standard Deviation 0.83 |
| Psychoeducation | Change in Wellness Measures - Self-efficacy | Session 5 | 2.57 score on a scale | Standard Deviation 0.88 |
| Psychoeducation, Lacking Classification Measures | Change in Wellness Measures - Self-efficacy | Baseline | 2.15 score on a scale | Standard Deviation 1.04 |