Adjustment Disorders, Anxiety, Depression, Stress Related Disorder
Conditions
Brief summary
Among primary care patients, compare the effectiveness of an 8-week mindfulness-based intervention (Mindfulness Training for Primary Care\[MTPC\]) vs. a low-dose mindfulness introduction comparator on self-management of chronic illness and illness-related health behavior action plan initiation, as well as on measures related to anxiety, depression, and stress.
Detailed description
This study builds on a pilot study that investigated the impact of Mindfulness Training for Primary Care on anxiety, depression, stress, and chronic illness self-management in primary care patients receiving care in an urban, community, multi-cultural safety net healthcare system. The current comparative effectiveness randomized controlled trial takes place in a larger sample, and investigates the impact of a refined MTPC curriculum on specific aspects of self-regulation such as action plan initiation, while examining potential mechanisms of change, including self-efficacy, perceived control, mindfulness, self-compassion, emotion regulation, and body awareness. Participants randomized to MTPC are compared with participants who are randomized to a low-dose comparator condition and receive a 1-hour introduction to mindfulness with a referral to community mindfulness resources. Outcome assessments are conducted at baseline and study weeks 8-10.
Interventions
BEHAVIORALMindfulness Training for Primary Care
MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.
BEHAVIORAL60-minute Introduction to Mindfulness
Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
Sponsors
The Arthur Vining Davis Foundations
The Arnold P. Gold Foundation
National Institutes of Health (NIH)
Brown University
National Center for Complementary and Integrative Health (NCCIH)
Cambridge Health Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two arms, intervention and low-dose comparator, which are randomly assigned at the same time and are implemented in parallel.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current CHA patient with an enrolled CHA primary care doctor. * CHA patients 18 years of age and older. * Able to tolerate and participate in interviews and engage in all procedures. * Able to give written consent in English OR willing and able to provide consent and complete assessments through a professional language translator when necessary. * Diagnosis eligible to be covered by insurance for group visits (e.g., anxiety disorder, depression, or adjustment disorder related to chronic illness, pain, etc.).
Exclusion criteria
* Any cognitive impairment that precludes informed consent. * Patients who, in the opinion of the Principal Investigator, pose an imminent risk of suicide or danger to self or others. * Likelihood of potential incarceration such as a conviction or pending charges that may potentially result in imprisonment. * Previous enrollment or randomization of treatment in the present study within the 12 months. * Behaviors that may cause disruption to a mindfulness group. * Patients with symptoms of psychosis, thought disorder, and/or severe mental illness, including schizophrenia, schizoaffective, bipolar disorder, or a current severe episode of major depressive disorder. * Lack of insurance coverage for group psychotherapy may preclude participation in groups. * Patients in their third trimester of pregnancy who foresee conflicts that preclude their commitment to completing all activities. * Patients with highly unstable medical problems that put them at a high risk of hospitalization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action Plan Initiation Survey (APIS-5) | Weeks 8-10 | The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable). For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal. |
| Perceived Stress Scale | Baseline and week 8 (pre to post Intervention) | The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress). |
| Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) | Baseline and week 8 (pre to post Intervention) | The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity). |
| Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) | Baseline and week 8 (pre to post Intervention) | The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difficulty in Emotion Regulation Scale (DERS) | Baseline and week 8 (pre to post Intervention) | The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never \[0-10%\]) to 5 (almost always \[91-100%\]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation). |
| Five Facet Mindfulness Questionnaire (FFMQ) | Baseline and week 8 (pre to post Intervention) | The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome). |
| Multidimensional Assessment of Interoceptive Awareness (MAIA) | Baseline and week 8 (pre to post Intervention) | The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception). |
| Self-Compassion Scale-Short Form (SCS-SF) | Baseline and week 8 (pre to post Intervention) | The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion. |
| Change in Self-Efficacy for Managing Chronic Disease (SECD-6) | Baseline and week 8 (pre to post Intervention) | The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy). |
| Perceived Control Questionnaire (PCQ) | Baseline and week 8 (pre to post Intervention) | The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 11 metro-north Boston primary care Patient Centered Medical Homes via print and digital flyers, as well as referrals from primary and mental health care settings confirmed by a primary care provider. 465 participants were recruited.
Pre-assignment details
All participants received a 60-minute introduction to mindfulness led by an MTPC group leader prior to randomization. The session included a conceptual/experiential mindfulness introduction, inquiry, and digital and print resources. Participants were able to decline study continuation after the 60-minute introduction and before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Training for Primary Care Mindfulness Training for Primary Care (MTPC) is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements integrated with novel mindfulness-oriented behavior change elements into a format that is adaptable to delivery in primary care health centers.
Mindfulness Training for Primary Care: MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7. | 92 |
| Low-dose Comparator Comparator arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month wait-list for a Cambridge Health Alliance mindfulness-based intervention group and allowed to receive behavioral and medical referrals and treatment as usual. All participants complete an action planning protocol during Week 7.
60-minute Introduction to Mindfulness: Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources. | 44 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 5 |
| Overall Study | Partially completed 8 wk or 24 wk survey | 3 | 5 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Total | Mindfulness Training for Primary Care | Low-dose Comparator |
|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 12.5 | 40.6 years STANDARD_DEVIATION 12.7 | 40.3 years STANDARD_DEVIATION 12.2 |
| Annual Income <$20,000 | 40 Participants | 31 Participants | 9 Participants |
| Any depression diagnosis | 67 Participants | 48 Participants | 19 Participants |
| Any PTSD diagnosis | 12 Participants | 11 Participants | 1 Participants |
| Baseline meditation practice | 5.9 minutes/day STANDARD_DEVIATION 9.4 | 6.8 minutes/day STANDARD_DEVIATION 10.5 | 4.1 minutes/day STANDARD_DEVIATION 6.5 |
| DSM-V diagnosis 2+ DSM-V diagnosis | 47 Participants | 33 Participants | 14 Participants |
| DSM-V diagnosis Single DSM-V diagnosis | 89 Participants | 59 Participants | 30 Participants |
| Education | 16.2 years STANDARD_DEVIATION 3.4 | 16.6 years STANDARD_DEVIATION 3.1 | 15.5 years STANDARD_DEVIATION 4.1 |
| English as second language | 24 Participants | 19 Participants | 5 Participants |
| Have practiced meditation before | 78 Participants | 56 Participants | 22 Participants |
| Insurance Medicaid or Medicare | 20 Participants | 12 Participants | 8 Participants |
| Insurance Other | 4 Participants | 2 Participants | 2 Participants |
| Insurance Private | 61 Participants | 39 Participants | 22 Participants |
| Insurance Subsidized | 51 Participants | 39 Participants | 12 Participants |
| Marital Status Divorced | 15 Participants | 13 Participants | 2 Participants |
| Marital Status Married/cohabitating | 49 Participants | 32 Participants | 17 Participants |
| Marital Status Other | 3 Participants | 2 Participants | 1 Participants |
| Marital Status Single | 67 Participants | 44 Participants | 23 Participants |
| Marital Status Widowed | 2 Participants | 1 Participants | 1 Participants |
| Primary DSM-V diagnosis Adjustment disorder | 21 Participants | 11 Participants | 10 Participants |
| Primary DSM-V diagnosis Anxiety NOS | 20 Participants | 14 Participants | 6 Participants |
| Primary DSM-V diagnosis Generalized anxiety disorder | 23 Participants | 16 Participants | 7 Participants |
| Primary DSM-V diagnosis Major depressive disorder | 37 Participants | 27 Participants | 10 Participants |
| Primary DSM-V diagnosis Other | 20 Participants | 15 Participants | 5 Participants |
| Primary DSM-V diagnosis Other depressive disorder | 15 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 21 Participants | 17 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 115 Participants | 75 Participants | 40 Participants |
| Race/Ethnicity, Customized Race Black | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Other | 24 Participants | 16 Participants | 8 Participants |
| Race/Ethnicity, Customized Race White | 105 Participants | 73 Participants | 32 Participants |
| Sex: Female, Male Female | 89 Participants | 63 Participants | 26 Participants |
| Sex: Female, Male Male | 47 Participants | 29 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 44 |
| other Total, other adverse events | 8 / 92 | 4 / 44 |
| serious Total, serious adverse events | 4 / 92 | 0 / 44 |
Outcome results
Primary
Action Plan Initiation Survey (APIS-5)
The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable). For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal.
Time frame: Weeks 8-10
Population: Using mixed effects intent-to-treat analysis, we defined non-initiator status as participants who never endorsed greater than 4 or who did not complete the API survey. by week 9. The APIS-5 is analyzed using an intent to treat analysis and missing APIS is considered incomplete action plan initiation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Training for Primary Care | Action Plan Initiation Survey (APIS-5) | 53 Participants |
| Low-dose Comparator | Action Plan Initiation Survey (APIS-5) | 14 Participants |
p-value: 0.006Unadjusted bivariate logistic regression
Primary
Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) | Baseline | 63.9 score on a scale | Standard Deviation 6.9 |
| Mindfulness Training for Primary Care | Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) | 8 Weeks | 58.5 score on a scale | Standard Deviation 6.6 |
| Low-dose Comparator | Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) | Baseline | 61.9 score on a scale | Standard Deviation 6.6 |
| Low-dose Comparator | Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF) | 8 Weeks | 58.9 score on a scale | Standard Deviation 6.9 |
p-value: 0.12Mixed Models Analysis
Primary
Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)
The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) | Baseline | 59.2 score on a scale | Standard Deviation 8.6 |
| Mindfulness Training for Primary Care | Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) | 8 Weeks | 53.9 score on a scale | Standard Deviation 7.9 |
| Low-dose Comparator | Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) | Baseline | 58.0 score on a scale | Standard Deviation 8.6 |
| Low-dose Comparator | Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF) | 8 Weeks | 55.6 score on a scale | Standard Deviation 8 |
p-value: 0.08Mixed Models Analysis
Primary
Perceived Stress Scale
The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Perceived Stress Scale | Baseline | 25.0 score on a scale | Standard Deviation 6.7 |
| Mindfulness Training for Primary Care | Perceived Stress Scale | 8 Weeks | 19.9 score on a scale | Standard Deviation 6.3 |
| Low-dose Comparator | Perceived Stress Scale | Baseline | 24.3 score on a scale | Standard Deviation 6.6 |
| Low-dose Comparator | Perceived Stress Scale | 8 Weeks | 20.9 score on a scale | Standard Deviation 6.3 |
p-value: 0.19Mixed Models Analysis
Secondary
Change in Self-Efficacy for Managing Chronic Disease (SECD-6)
The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Change in Self-Efficacy for Managing Chronic Disease (SECD-6) | Baseline | 6.1 score on a scale | Standard Deviation 1.9 |
| Mindfulness Training for Primary Care | Change in Self-Efficacy for Managing Chronic Disease (SECD-6) | 8 Weeks | 6.7 score on a scale | Standard Deviation 1.6 |
| Low-dose Comparator | Change in Self-Efficacy for Managing Chronic Disease (SECD-6) | Baseline | 6.2 score on a scale | Standard Deviation 2 |
| Low-dose Comparator | Change in Self-Efficacy for Managing Chronic Disease (SECD-6) | 8 Weeks | 6.5 score on a scale | Standard Deviation 1.7 |
p-value: 0.31Mixed Models Analysis
Secondary
Difficulty in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never \[0-10%\]) to 5 (almost always \[91-100%\]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Difficulty in Emotion Regulation Scale (DERS) | Baseline | 76.1 score on a scale | Standard Deviation 23 |
| Mindfulness Training for Primary Care | Difficulty in Emotion Regulation Scale (DERS) | 8 Weeks | 60.2 score on a scale | Standard Deviation 21.8 |
| Low-dose Comparator | Difficulty in Emotion Regulation Scale (DERS) | Baseline | 72.2 score on a scale | Standard Deviation 23.2 |
| Low-dose Comparator | Difficulty in Emotion Regulation Scale (DERS) | 8 Weeks | 68.8 score on a scale | Standard Deviation 21.8 |
p-value: <0.001Mixed Models Analysis
Secondary
Five Facet Mindfulness Questionnaire (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8-40, with the exception of the nonreactivity facet, which ranges from 7-35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Five Facet Mindfulness Questionnaire (FFMQ) | Baseline | 115.8 score on a scale | Standard Deviation 18.2 |
| Mindfulness Training for Primary Care | Five Facet Mindfulness Questionnaire (FFMQ) | 8 Weeks | 132.0 score on a scale | Standard Deviation 16.9 |
| Low-dose Comparator | Five Facet Mindfulness Questionnaire (FFMQ) | Baseline | 115.6 score on a scale | Standard Deviation 24.5 |
| Low-dose Comparator | Five Facet Mindfulness Questionnaire (FFMQ) | 8 Weeks | 119.4 score on a scale | Standard Deviation 26.4 |
p-value: <0.001Mixed Models Analysis
Secondary
Multidimensional Assessment of Interoceptive Awareness (MAIA)
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Multidimensional Assessment of Interoceptive Awareness (MAIA) | Baseline | 2.4 score on a scale | Standard Deviation 0.73 |
| Mindfulness Training for Primary Care | Multidimensional Assessment of Interoceptive Awareness (MAIA) | 8 Weeks | 3.1 score on a scale | Standard Deviation 0.64 |
| Low-dose Comparator | Multidimensional Assessment of Interoceptive Awareness (MAIA) | Baseline | 2.5 score on a scale | Standard Deviation 0.73 |
| Low-dose Comparator | Multidimensional Assessment of Interoceptive Awareness (MAIA) | 8 Weeks | 2.6 score on a scale | Standard Deviation 0.69 |
p-value: <0.001Mixed Models Analysis
Secondary
Perceived Control Questionnaire (PCQ)
The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Perceived Control Questionnaire (PCQ) | Baseline | 23.5 score on a scale | Standard Deviation 4.4 |
| Mindfulness Training for Primary Care | Perceived Control Questionnaire (PCQ) | 8 Weeks | 25.3 score on a scale | Standard Deviation 4.2 |
| Low-dose Comparator | Perceived Control Questionnaire (PCQ) | Baseline | 23.0 score on a scale | Standard Deviation 4.4 |
| Low-dose Comparator | Perceived Control Questionnaire (PCQ) | 8 Weeks | 23.8 score on a scale | Standard Deviation 4.3 |
p-value: 0.26Mixed Models Analysis
Secondary
Self-Compassion Scale-Short Form (SCS-SF)
The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.
Time frame: Baseline and week 8 (pre to post Intervention)
Population: We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Training for Primary Care | Self-Compassion Scale-Short Form (SCS-SF) | Baseline | 2.6 score on a scale | Standard Deviation 0.67 |
| Mindfulness Training for Primary Care | Self-Compassion Scale-Short Form (SCS-SF) | 8 Weeks | 3.1 score on a scale | Standard Deviation 0.65 |
| Low-dose Comparator | Self-Compassion Scale-Short Form (SCS-SF) | Baseline | 2.6 score on a scale | Standard Deviation 0.73 |
| Low-dose Comparator | Self-Compassion Scale-Short Form (SCS-SF) | 8 Weeks | 2.8 score on a scale | Standard Deviation 0.69 |
p-value: 0.03Mixed Models Analysis