Anxiety, Depression
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and targets of Positive Affect Treatment, a psychotherapy specifically aimed at enhancing reward sensitivity in individuals with low positive affect (a core feature of anhedonia) in the context of depression or anxiety. Target enrollment is 68 male and female participants with low positive affect and depression or anxiety and impaired functioning, between the ages of 18 and 65 years, who will be randomized to either Positive Affect Treatment or Negative Affect Treatment (designed to reduce threat sensitivity). Participants will complete laboratory tests, psychiatric assessments, and self-report questionnaires as part of the study. The total length of participation is around 4 months.
Detailed description
Low positive affect in the context of depression or anxiety has been relatively resistant to pharmacological and psychological treatments. Newer treatments that focus upon positivity or reward sensitivity have shown promising results. As an NIMH funded R61 phase trial, the purpose of the current randomized controlled trial is to evaluate the efficacy and targets of Positive Affect Treatment (designed to augment reward sensitivity) for individuals with low positive affect in the context of depression or anxiety symptoms. Targets include behavioral, cognitive, physiological and experiential measures of three reward processes: reward anticipation, response to reward attainment, and reward learning. Specificity of target engagement is assessed by comparison with Negative Affect Treatment, designed to reduce threat sensitivity. Clinical outcomes are assessed at baseline and either weekly or at Week 5, Week 10, and Week 15 (post). Targets are assessed at baseline, Week 5, Week 10, and Week 15. Statistical models evaluate whether change in outcomes and change in target measures are greater as a result of Positive Affect Treatment compared to Negative Affect Treatment and whether changes in target measures correlate with changes in outcome measures. Target enrollment is 68 male and female participants with low positive affect and depression or anxiety and impaired functioning between the ages of 18 and 65 who will be randomized to Positive Affect Treatment or Negative Affect Treatment, each comprising 15 individual psychotherapy sessions. Participants will complete laboratory tests and psychiatric assessments and self-report questionnaires as part of the study. Total length of participation is around 4 months.
Interventions
BEHAVIORALPositive Affect Treatment
Sessions 1-7: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects (continued for sessions 8-15) Sessions 8-10: Cognitive exercises focusing on identifying positive aspects of experience, taking responsibility for positive outcomes, and imagining future positive events Sessions 11-14: Exercises to cultivate and savor positive experiences Session 15: Relapse prevention.
BEHAVIORALNegative Affect Treatment
Sessions 1-7: Exposure therapy to feared or avoided situations, sensations, or memories (continued for sessions 8-15) Sessions 8-10: Cognitive restructuring of probability, cost, and attributional biases Sessions 11-14: Capnometry-assisted respiratory training Session 15: Relapse prevention
Sponsors
Southern Methodist University
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* English-speaking * Low positive affect indexed by less than or equal to 24 on the positive affect subscale of the PANAS (i.e., PANAS-P); and scores of greater than or equal to 11 for depression, greater to or equal to 6 for anxiety, or greater to or equal to 10 for stress on the Depression, Anxiety, and Stress Scale; and scores of greater than or equal to 5 on any Sheehan Disability Scale subscale. * Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.
Exclusion criteria
* Patient report of serious medical conditions - such as history of serious, uncontrolled medical illness, or instability (including significant cardio-pulmonary disease, organic brain syndrome, seizure disorder, cerebrovascular disease, thyroid dysfunction, and diabetes) * Active suicidal ideation * Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage * Substance abuse in the last 6 months or dependence within last 12 months. * 11 or more cigarettes per week or nicotine equivalent. * History of marijuana, cocaine or stimulant use 5-7 times/week or more before age 15 (e.g., amphetamine, cocaine, methamphetamine) * Pregnancy * Bupropion, dopaminergic or neuroleptic medication use in the past 6 months * Heterocyclics and SSRIs are permitted if stabilized (3 months) and PRN benzodiazepines and beta-blockers are permitted but discouraged on laboratory assessment visits * Refusal of video/audio-taping
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 0, Week 5, Week 10, Week 16 | Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. |
| Interviewer Anhedonia Ratings | Week 0, Week 5, Week 10, Week 16 | Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia. |
| Depression Anxiety and Stress Scale (DASS-21) | Week 0, Week 5, Week 10, Week 16 | Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effort Expenditure for Rewards Task (EEfRT) | Week 0, Week 5, Week 10, Week 16 | The Effort Expenditure for Rewards Task (EEfRT) is a computer-based multi-trial task used to objectively assess decision-making and willingness to expend effort for reward. The dependent variable is the ratio of hard (high-effort) choices to the total number of trials. Results range from 0 to 1, with higher values indicating a higher proportion of hard (high-effort) choices. Results show the mean proportion of high-effort choices. |
| Monetary Incentive Task | Week 0, Week 5, Week 10, Week 16 | Heart rate acceleration during the Monetary Incentive Task (MIT) was used to measure cardiac responding to the prospect of a monetary reward. The dependent variable is the interbeat interval acceleration during the task (score range in our sample: -0.16 to 0.17). Higher values indicate greater cardiac responding to the prospect of monetary reward. |
| Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 0, Week 5, Week 10, Week 16 | Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity |
| Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 0, Week 5, Week 10, Week 16 | Mediator: Reported reward desire, motivation, and effort (score range: 0-76) with higher scores indicating higher degree of reward desire, motivation, and effort. |
| Dimensional Anhedonia Rating Scale-Consummatory Items | Week 0, Week 5, Week 10, Week 16 | Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure. |
| Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 0, Week 5, Week 10, Week 16 | The Modified Attentional Dot Probe Task is a computer-based multi-trial task used to objectively assess attentional bias toward positively- and negatively-valenced stimuli. The dependent variable is the reaction time index for disengagement bias from sad faces. This is calculated as follows: (Cue appears proximal to emotional face in the pair of emotional face and random blur image: reaction time for target distal to emotional face minus reaction time for target proximal to emotional face) minus (Cue proximal to neutral face in pair of neutral face and random blur image: reaction time for target distal to neutral face minus reaction time for target proximal to neutral face). The range of values in our sample was: -309.28 to 283.45. |
| Sheehan Disability Scale (SDS) | Week 0, Week 5, Week 10, Week 16 | Reported impairment due to symptoms (score range: 0-30) with higher scores indicating greater impairment. Includes reported number of days of missed school/work and number of days of reduced productivity. Statistical analyses have not yet been conducted for this outcome measure. |
| International Affective Picture System Task | Week 0, Week 5, Week 10, Week 16 | Heart rate acceleration during presentation of images from the International Affective Picture Systems (IAPS) was used to assess cardiac responding to positive images. The dependent variable is heart rate acceleration during the 6 seconds of positive image presentation relative to the last 2 seconds before picture onset. Higher values indicate greater cardiac responding to positive images. The range of values in our sample was: -0.12 to 0.09. |
| Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 0, Week 5, Week 10, Week 16 | Mediator: Reported reward consummatory pleasure (score range: 8-48), with higher scores indicating higher reported reward consummatory pleasure |
| Probabilistic Reward Task (PRT) | Week 0, Week 5, Week 10, Week 16 | The Probabilistic Reward Task (PRT) is a computer-based multi-trial task used to objectively assess the propensity to modulate behavior as a function of prior reinforcements. The dependent variable is response bias (measured as accuracy) toward the more frequently rewarded stimulus. A high response bias emerges when subjects show high rates of correct identification (hits) for the rich stimulus and high miss rates for the lean stimulus (i.e., the stimulus associated with less frequent rewards). Higher values indicate a greater propensity to modulate behavior as a function of prior reinforcements. The range of values in our sample was: -0.58 to 0.78. |
| Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 0, Week 5, Week 10, Week 16 | The Pavlovian Instrumental Transfer (PIT) task assesses the extent to which a conditional stimulus paired with reward influences instrumental responding to gain rewards. The dependent variable was handgrip force exerted in response to stimuli during a test phase following Pavlovian conditioning. Higher values indicate greater instrumental responding to gain rewards as a function of Pavlovian conditioning to a conditional stimulus paired with reward. The range of values in our sample was: -18.76 to 61.30. |
| Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 0, Week 5, Week 10, Week 16 | Within the Pavlovian Instrumental Transfer Task (PIT), participants rate the pleasantness (0-4) for three conditional stimuli to indicate the perceived value of reward associated with each one. The dependent variable is the self-reported pleasantness for rewarded stimuli compared to nonrewarded stimuli. This is calculated by first taking the average of participants' pleasantness ratings for the three CS+s and CS-s, and then subtracting the average CS- ratings from the average CS+ ratings. Higher values indicate greater responding to Pavlovian conditioning during the task. |
| Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 0, Week 5, Week 10, Week 16 | The Modified Attentional Dot Probe Task is a computer-based multi-trial task used to objectively assess attentional bias toward positively- and negatively-valenced stimuli. The dependent variable is the reaction time index for engagement bias from happy faces. This is calculated as follows: (Cue probe distal to negative image in negative/abstract image pair: RT for target probe distal to negative image minus RT for target probe proximal to negative image) minus (Cue probe distal to neutral image in neutral/abstract image pair: RT for target probe distal to neutral image minus RT for target probe proximal to neutral image). The range of data in our sample was: -237.82 to to 343.93. Statistical analyses have not yet been conducted for this outcome measure. |
| Beck Depression Inventory (BDI) | Week 0, Week 5, Week 10, Week 16 | Reported suicidal ideation (item 9 on the BDI), scores range from 0-3 with higher scores indicating a higher degree of suicidal ideation. Statistical analyses have not yet been conducted for this outcome measure. |
| Daily Activity/Social Interaction (Actigraph) | Week 0, Week 5, Week 10, Week 16 | We intended to collect data on energy expenditure over four 7-day periods (at week 0, week 5, week 10, and week 16) using a wrist-worn Actigraph tri-axial accelerometer. However, the use of Actigraph monitors was terminated early in the study due to the onset of the COVID-19 pandemic. |
Countries
United States
Participant flow
Recruitment details
Recruitment began February 23, 2019 and ended February 5, 2021. A brief study description was distributed via lab websites, social media, ClinicalTrials.gov, and campus and local area flyers.
Pre-assignment details
1062 individuals completed an online screening. 517 were excluded due to ineligibility and 114 did not follow up. 431 were scheduled for a phone screen. 27 declined, 131 were excluded due to ineligibility, and 60 could not be reached. The remaining 213 were scheduled for a diagnostic assessment. 30 declined to participate, 46 were excluded due to ineligibility or other reasons, and 45 could not be reached. 92 participants were eligible. 7 withdrew during or after assessment. 85 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Positive Affect Treatment 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.
Positive Affect Treatment: Sessions 1-7: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects (continued for sessions 8-15) Sessions 8-10: Cognitive exercises focusing on identifying positive aspects of experience, taking responsibility for positive outcomes, and imagining future positive events Sessions 11-14: Exercises to cultivate and savor positive experiences Session 15: Relapse prevention. | 42 |
| Negative Affect Treatment 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.
Negative Affect Treatment: Sessions 1-7: Exposure therapy to feared or avoided situations, sensations, or memories (continued for sessions 8-15) Sessions 8-10: Cognitive restructuring of probability, cost, and attributional biases Sessions 11-14: Capnometry-assisted respiratory training Session 15: Relapse prevention | 43 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 11 | 17 |
Baseline characteristics
| Characteristic | Total | Negative Affect Treatment | Positive Affect Treatment |
|---|---|---|---|
| Adjustment disorder | 2 Participants | 1 Participants | 1 Participants |
| Age, Continuous | 31.73 years STANDARD_DEVIATION 12.3 | 31.51 years STANDARD_DEVIATION 13.1 | 31.95 years STANDARD_DEVIATION 11.5 |
| Agoraphobia | 3 Participants | 2 Participants | 1 Participants |
| Anxiety diagnoses | 50 Participants | 26 Participants | 24 Participants |
| Any diagnosis | 76 Participants | 39 Participants | 37 Participants |
| Attention deficit hyperactivity | 14 Participants | 5 Participants | 9 Participants |
| Current psychotropic medication | 24 Participants | 12 Participants | 12 Participants |
| Depressive diagnoses | 58 Participants | 31 Participants | 27 Participants |
| Generalized anxiety disorder | 31 Participants | 16 Participants | 15 Participants |
| Major depressive disorder | 46 Participants | 27 Participants | 19 Participants |
| Marital status Divorced | 3 Participants | 0 Participants | 3 Participants |
| Marital status Married | 19 Participants | 10 Participants | 9 Participants |
| Marital status Separated | 2 Participants | 1 Participants | 1 Participants |
| Marital status Single, in a relationship | 23 Participants | 13 Participants | 10 Participants |
| Marital status Single, not in a relationship | 38 Participants | 19 Participants | 19 Participants |
| Obsessive compulsive disorder | 3 Participants | 3 Participants | 0 Participants |
| Panic disorder | 10 Participants | 5 Participants | 5 Participants |
| Persistent depressive disorder | 33 Participants | 16 Participants | 17 Participants |
| Posttraumatic stress disorder | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Alaska Native/Native American/Indigenous | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 17 Participants | 9 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino (non-White) | 8 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latino (White) | 15 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Multiracial | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 7 Participants | 1 Participants |
| Race/Ethnicity, Customized Pacific Islander/Native Hawaiian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 53 Participants | 25 Participants | 28 Participants |
| Sex: Female, Male Female | 67 Participants | 36 Participants | 31 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 11 Participants |
| Social anxiety disorder | 34 Participants | 17 Participants | 17 Participants |
| Specific phobia | 7 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 43 |
| other Total, other adverse events | 0 / 42 | 3 / 43 |
| serious Total, serious adverse events | 0 / 42 | 0 / 43 |
Outcome results
Primary
Depression Anxiety and Stress Scale (DASS-21)
Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 0 | 27.36 score on a scale | Standard Deviation 11.27 |
| Positive Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 5 | 17.90 score on a scale | Standard Deviation 11.56 |
| Positive Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 10 | 11.55 score on a scale | Standard Deviation 9.6 |
| Positive Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 16 | 9.09 score on a scale | Standard Deviation 6.85 |
| Negative Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 16 | 12.38 score on a scale | Standard Deviation 10.9 |
| Negative Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 0 | 24.51 score on a scale | Standard Deviation 10.54 |
| Negative Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 10 | 13.00 score on a scale | Standard Deviation 12.13 |
| Negative Affect Treatment | Depression Anxiety and Stress Scale (DASS-21) | Week 5 | 17.92 score on a scale | Standard Deviation 10.51 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.p-value: 0.024Mixed Models Analysis
Primary
Interviewer Anhedonia Ratings
Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Interviewer Anhedonia Ratings | Week 0 | 7.66 score on a scale | Standard Deviation 2.13 |
| Positive Affect Treatment | Interviewer Anhedonia Ratings | Week 5 | 6.11 score on a scale | Standard Deviation 2.26 |
| Positive Affect Treatment | Interviewer Anhedonia Ratings | Week 10 | 4.91 score on a scale | Standard Deviation 2.19 |
| Positive Affect Treatment | Interviewer Anhedonia Ratings | Week 16 | 4.19 score on a scale | Standard Deviation 1.47 |
| Negative Affect Treatment | Interviewer Anhedonia Ratings | Week 16 | 4.43 score on a scale | Standard Deviation 2.23 |
| Negative Affect Treatment | Interviewer Anhedonia Ratings | Week 0 | 7.47 score on a scale | Standard Deviation 1.8 |
| Negative Affect Treatment | Interviewer Anhedonia Ratings | Week 10 | 4.93 score on a scale | Standard Deviation 2.4 |
| Negative Affect Treatment | Interviewer Anhedonia Ratings | Week 5 | 5.49 score on a scale | Standard Deviation 2.4 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.p-value: >0.05Mixed Models Analysis
Primary
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 0 | 20.76 score on a scale | Standard Deviation 7.42 |
| Positive Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 5 | 24.18 score on a scale | Standard Deviation 7.37 |
| Positive Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 10 | 26.88 score on a scale | Standard Deviation 8.29 |
| Positive Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 16 | 27.30 score on a scale | Standard Deviation 7.23 |
| Negative Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 16 | 23.85 score on a scale | Standard Deviation 9.28 |
| Negative Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 0 | 29.42 score on a scale | Standard Deviation 4.74 |
| Negative Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 10 | 22.57 score on a scale | Standard Deviation 9.82 |
| Negative Affect Treatment | Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) | Week 5 | 19.42 score on a scale | Standard Deviation 8.12 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference between PAT and NAT as small as d=.35.p-value: 0.002Mixed Models Analysis
Secondary
Beck Depression Inventory (BDI)
Reported suicidal ideation (item 9 on the BDI), scores range from 0-3 with higher scores indicating a higher degree of suicidal ideation. Statistical analyses have not yet been conducted for this outcome measure.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Beck Depression Inventory (BDI) | Week 10 | 0.18 score on a scale | Standard Deviation 0.39 |
| Positive Affect Treatment | Beck Depression Inventory (BDI) | Week 0 | 0.17 score on a scale | Standard Deviation 0.38 |
| Positive Affect Treatment | Beck Depression Inventory (BDI) | Week 16 | 0.23 score on a scale | Standard Deviation 0.43 |
| Positive Affect Treatment | Beck Depression Inventory (BDI) | Week 5 | 0.18 score on a scale | Standard Deviation 0.39 |
| Negative Affect Treatment | Beck Depression Inventory (BDI) | Week 16 | 0.08 score on a scale | Standard Deviation 0.27 |
| Negative Affect Treatment | Beck Depression Inventory (BDI) | Week 5 | 0.14 score on a scale | Standard Deviation 0.35 |
| Negative Affect Treatment | Beck Depression Inventory (BDI) | Week 0 | 0.23 score on a scale | Standard Deviation 0.43 |
| Negative Affect Treatment | Beck Depression Inventory (BDI) | Week 10 | 0.20 score on a scale | Standard Deviation 0.41 |
Secondary
Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 0 | 9.67 score on a scale | Standard Deviation 2.63 |
| Positive Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 5 | 10.50 score on a scale | Standard Deviation 2.63 |
| Positive Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 10 | 10.66 score on a scale | Standard Deviation 2.51 |
| Positive Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 16 | 10.30 score on a scale | Standard Deviation 2.56 |
| Negative Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 16 | 11.08 score on a scale | Standard Deviation 1.96 |
| Negative Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 0 | 9.42 score on a scale | Standard Deviation 2.21 |
| Negative Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 10 | 10.66 score on a scale | Standard Deviation 2.36 |
| Negative Affect Treatment | Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD) | Week 5 | 10.14 score on a scale | Standard Deviation 2.26 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.591Mixed Models Analysis
Secondary
Daily Activity/Social Interaction (Actigraph)
We intended to collect data on energy expenditure over four 7-day periods (at week 0, week 5, week 10, and week 16) using a wrist-worn Actigraph tri-axial accelerometer. However, the use of Actigraph monitors was terminated early in the study due to the onset of the COVID-19 pandemic.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 5 | 41.98 kcals expended per hour | Standard Deviation 20.58 |
| Positive Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 16 | 43.69 kcals expended per hour | Standard Deviation 27.13 |
| Positive Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 0 | 40.212 kcals expended per hour | Standard Deviation 19.677 |
| Positive Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 10 | 34.21 kcals expended per hour | Standard Deviation 20.75 |
| Negative Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 10 | 46.92 kcals expended per hour | Standard Deviation 29.33 |
| Negative Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 5 | 41.44 kcals expended per hour | Standard Deviation 26.06 |
| Negative Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 0 | 34.634 kcals expended per hour | Standard Deviation 24.427 |
| Negative Affect Treatment | Daily Activity/Social Interaction (Actigraph) | Week 16 | 56.57 kcals expended per hour | Standard Deviation 53.04 |
Secondary
Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
Mediator: Reported reward desire, motivation, and effort (score range: 0-76) with higher scores indicating higher degree of reward desire, motivation, and effort.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 0 | 42.85 score on a scale | Standard Deviation 16.96 |
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 5 | 52.28 score on a scale | Standard Deviation 14.2 |
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 10 | 55.63 score on a scale | Standard Deviation 15.69 |
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 16 | 59.84 score on a scale | Standard Deviation 14.31 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 16 | 58.46 score on a scale | Standard Deviation 16.31 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 0 | 49.16 score on a scale | Standard Deviation 16.32 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 10 | 55.66 score on a scale | Standard Deviation 16.08 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items | Week 5 | 52.46 score on a scale | Standard Deviation 15.36 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.004Mixed Models Analysis
Secondary
Dimensional Anhedonia Rating Scale-Consummatory Items
Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 0 | 17.56 score on a scale | Standard Deviation 6.26 |
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 5 | 20.39 score on a scale | Standard Deviation 4.76 |
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 10 | 21.50 score on a scale | Standard Deviation 5.66 |
| Positive Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 16 | 22.88 score on a scale | Standard Deviation 4.73 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 16 | 22.12 score on a scale | Standard Deviation 5.78 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 0 | 19.12 score on a scale | Standard Deviation 6.16 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 10 | 21.59 score on a scale | Standard Deviation 5.99 |
| Negative Affect Treatment | Dimensional Anhedonia Rating Scale-Consummatory Items | Week 5 | 20.51 score on a scale | Standard Deviation 6.25 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.03Mixed Models Analysis
Secondary
Effort Expenditure for Rewards Task (EEfRT)
The Effort Expenditure for Rewards Task (EEfRT) is a computer-based multi-trial task used to objectively assess decision-making and willingness to expend effort for reward. The dependent variable is the ratio of hard (high-effort) choices to the total number of trials. Results range from 0 to 1, with higher values indicating a higher proportion of hard (high-effort) choices. Results show the mean proportion of high-effort choices.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 10 | 0.51 proportion of high effort choices | Standard Deviation 0.26 |
| Positive Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 5 | 0.43 proportion of high effort choices | Standard Deviation 0.22 |
| Positive Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 16 | 0.48 proportion of high effort choices | Standard Deviation 0.29 |
| Positive Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 0 | 0.41 proportion of high effort choices | Standard Deviation 0.2 |
| Negative Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 16 | 0.42 proportion of high effort choices | Standard Deviation 0.32 |
| Negative Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 0 | 0.41 proportion of high effort choices | Standard Deviation 0.27 |
| Negative Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 10 | 0.41 proportion of high effort choices | Standard Deviation 0.31 |
| Negative Affect Treatment | Effort Expenditure for Rewards Task (EEfRT) | Week 5 | 0.39 proportion of high effort choices | Standard Deviation 0.23 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.922Mixed Models Analysis
Secondary
International Affective Picture System Task
Heart rate acceleration during presentation of images from the International Affective Picture Systems (IAPS) was used to assess cardiac responding to positive images. The dependent variable is heart rate acceleration during the 6 seconds of positive image presentation relative to the last 2 seconds before picture onset. Higher values indicate greater cardiac responding to positive images. The range of values in our sample was: -0.12 to 0.09.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | International Affective Picture System Task | Week 10 | 0.0071 beats/ms^2 | Standard Deviation 0.0221 |
| Positive Affect Treatment | International Affective Picture System Task | Week 5 | -0.0016 beats/ms^2 | Standard Deviation 0.0222 |
| Positive Affect Treatment | International Affective Picture System Task | Week 16 | 0.0024 beats/ms^2 | Standard Deviation 0.0222 |
| Positive Affect Treatment | International Affective Picture System Task | Week 0 | 0.0003 beats/ms^2 | Standard Deviation 0.0243 |
| Negative Affect Treatment | International Affective Picture System Task | Week 16 | 0.0035 beats/ms^2 | Standard Deviation 0.0524 |
| Negative Affect Treatment | International Affective Picture System Task | Week 5 | -0.0061 beats/ms^2 | Standard Deviation 0.0331 |
| Negative Affect Treatment | International Affective Picture System Task | Week 10 | 0.0013 beats/ms^2 | Standard Deviation 0.0244 |
| Negative Affect Treatment | International Affective Picture System Task | Week 0 | -0.0007 beats/ms^2 | Standard Deviation 0.0238 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.494Mixed Models Analysis
Secondary
Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
The Modified Attentional Dot Probe Task is a computer-based multi-trial task used to objectively assess attentional bias toward positively- and negatively-valenced stimuli. The dependent variable is the reaction time index for disengagement bias from sad faces. This is calculated as follows: (Cue appears proximal to emotional face in the pair of emotional face and random blur image: reaction time for target distal to emotional face minus reaction time for target proximal to emotional face) minus (Cue proximal to neutral face in pair of neutral face and random blur image: reaction time for target distal to neutral face minus reaction time for target proximal to neutral face). The range of values in our sample was: -309.28 to 283.45.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 0 | -43.43 milliseconds (ms) | Standard Deviation 114.62 |
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 5 | 16.70 milliseconds (ms) | Standard Deviation 98.11 |
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 16 | 4.85 milliseconds (ms) | Standard Deviation 97 |
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 10 | -3.07 milliseconds (ms) | Standard Deviation 82.01 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 0 | 2.80 milliseconds (ms) | Standard Deviation 105.63 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 10 | -31.56 milliseconds (ms) | Standard Deviation 94.05 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 16 | 66.24 milliseconds (ms) | Standard Deviation 101.47 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli | Week 5 | -16.49 milliseconds (ms) | Standard Deviation 102.44 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.029Mixed Models Analysis
Secondary
Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
The Modified Attentional Dot Probe Task is a computer-based multi-trial task used to objectively assess attentional bias toward positively- and negatively-valenced stimuli. The dependent variable is the reaction time index for engagement bias from happy faces. This is calculated as follows: (Cue probe distal to negative image in negative/abstract image pair: RT for target probe distal to negative image minus RT for target probe proximal to negative image) minus (Cue probe distal to neutral image in neutral/abstract image pair: RT for target probe distal to neutral image minus RT for target probe proximal to neutral image). The range of data in our sample was: -237.82 to to 343.93. Statistical analyses have not yet been conducted for this outcome measure.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 0 | 9.30 milliseconds (ms) | Standard Deviation 105.87 |
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 5 | -17.65 milliseconds (ms) | Standard Deviation 90.72 |
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 10 | -20.86 milliseconds (ms) | Standard Deviation 69.89 |
| Positive Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 16 | -22.51 milliseconds (ms) | Standard Deviation 89.93 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 16 | 16.36 milliseconds (ms) | Standard Deviation 111.56 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 0 | 3.29 milliseconds (ms) | Standard Deviation 108.57 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 10 | -22.51 milliseconds (ms) | Standard Deviation 88.93 |
| Negative Affect Treatment | Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli | Week 5 | 2.62 milliseconds (ms) | Standard Deviation 96.57 |
Secondary
Monetary Incentive Task
Heart rate acceleration during the Monetary Incentive Task (MIT) was used to measure cardiac responding to the prospect of a monetary reward. The dependent variable is the interbeat interval acceleration during the task (score range in our sample: -0.16 to 0.17). Higher values indicate greater cardiac responding to the prospect of monetary reward.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Monetary Incentive Task | Week 0 | -0.012 beats/ms^2 | Standard Deviation 0.512 |
| Positive Affect Treatment | Monetary Incentive Task | Week 5 | 0.017 beats/ms^2 | Standard Deviation 0.048 |
| Positive Affect Treatment | Monetary Incentive Task | Week 10 | -0.002 beats/ms^2 | Standard Deviation 0.042 |
| Positive Affect Treatment | Monetary Incentive Task | Week 16 | 0.003 beats/ms^2 | Standard Deviation 0.026 |
| Negative Affect Treatment | Monetary Incentive Task | Week 16 | 0.026 beats/ms^2 | Standard Deviation 0.053 |
| Negative Affect Treatment | Monetary Incentive Task | Week 0 | -0.017 beats/ms^2 | Standard Deviation 0.046 |
| Negative Affect Treatment | Monetary Incentive Task | Week 10 | 0.004 beats/ms^2 | Standard Deviation 0.043 |
| Negative Affect Treatment | Monetary Incentive Task | Week 5 | 0.013 beats/ms^2 | Standard Deviation 0.061 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.049Mixed Models Analysis
Secondary
Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
The Pavlovian Instrumental Transfer (PIT) task assesses the extent to which a conditional stimulus paired with reward influences instrumental responding to gain rewards. The dependent variable was handgrip force exerted in response to stimuli during a test phase following Pavlovian conditioning. Higher values indicate greater instrumental responding to gain rewards as a function of Pavlovian conditioning to a conditional stimulus paired with reward. The range of values in our sample was: -18.76 to 61.30.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 0 | 6.30 volts | Standard Deviation 12.29 |
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 5 | 7.96 volts | Standard Deviation 15.61 |
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 10 | 6.55 volts | Standard Deviation 16.39 |
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 16 | 8.05 volts | Standard Deviation 16.34 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 16 | 1.24 volts | Standard Deviation 7.96 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 0 | 4.91 volts | Standard Deviation 13.54 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 10 | 6.57 volts | Standard Deviation 12.35 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Force (PIT-FORCE) | Week 5 | 6.72 volts | Standard Deviation 12.6 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.267Mixed Models Analysis
Secondary
Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
Within the Pavlovian Instrumental Transfer Task (PIT), participants rate the pleasantness (0-4) for three conditional stimuli to indicate the perceived value of reward associated with each one. The dependent variable is the self-reported pleasantness for rewarded stimuli compared to nonrewarded stimuli. This is calculated by first taking the average of participants' pleasantness ratings for the three CS+s and CS-s, and then subtracting the average CS- ratings from the average CS+ ratings. Higher values indicate greater responding to Pavlovian conditioning during the task.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 10 | 1.29 score on a scale | Standard Deviation 2.88 |
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 0 | 1.09 score on a scale | Standard Deviation 2.1 |
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 16 | 0.74 score on a scale | Standard Deviation 2.49 |
| Positive Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 5 | 1.50 score on a scale | Standard Deviation 2.5 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 16 | 1.93 score on a scale | Standard Deviation 1.9 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 5 | 0.73 score on a scale | Standard Deviation 2.99 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 10 | 0.44 score on a scale | Standard Deviation 2.94 |
| Negative Affect Treatment | Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE) | Week 0 | 0.62 score on a scale | Standard Deviation 2.17 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.051Mixed Models Analysis
Secondary
Probabilistic Reward Task (PRT)
The Probabilistic Reward Task (PRT) is a computer-based multi-trial task used to objectively assess the propensity to modulate behavior as a function of prior reinforcements. The dependent variable is response bias (measured as accuracy) toward the more frequently rewarded stimulus. A high response bias emerges when subjects show high rates of correct identification (hits) for the rich stimulus and high miss rates for the lean stimulus (i.e., the stimulus associated with less frequent rewards). Higher values indicate a greater propensity to modulate behavior as a function of prior reinforcements. The range of values in our sample was: -0.58 to 0.78.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Probabilistic Reward Task (PRT) | Week 10 | 0.09 Ratio | Standard Deviation 0.13 |
| Positive Affect Treatment | Probabilistic Reward Task (PRT) | Week 5 | 0.04 Ratio | Standard Deviation 0.27 |
| Positive Affect Treatment | Probabilistic Reward Task (PRT) | Week 16 | 0.16 Ratio | Standard Deviation 0.21 |
| Positive Affect Treatment | Probabilistic Reward Task (PRT) | Week 0 | 0.16 Ratio | Standard Deviation 0.19 |
| Negative Affect Treatment | Probabilistic Reward Task (PRT) | Week 16 | 0.15 Ratio | Standard Deviation 0.23 |
| Negative Affect Treatment | Probabilistic Reward Task (PRT) | Week 5 | 0.19 Ratio | Standard Deviation 0.27 |
| Negative Affect Treatment | Probabilistic Reward Task (PRT) | Week 10 | 0.03 Ratio | Standard Deviation 0.18 |
| Negative Affect Treatment | Probabilistic Reward Task (PRT) | Week 0 | 0.15 Ratio | Standard Deviation 0.29 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.344Mixed Models Analysis
Secondary
Sheehan Disability Scale (SDS)
Reported impairment due to symptoms (score range: 0-30) with higher scores indicating greater impairment. Includes reported number of days of missed school/work and number of days of reduced productivity. Statistical analyses have not yet been conducted for this outcome measure.
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Sheehan Disability Scale (SDS) | Week 0 | 18.40 score on a scale | Standard Deviation 6.14 |
| Positive Affect Treatment | Sheehan Disability Scale (SDS) | Week 5 | 14.53 score on a scale | Standard Deviation 6.46 |
| Positive Affect Treatment | Sheehan Disability Scale (SDS) | Week 10 | 11.19 score on a scale | Standard Deviation 6.34 |
| Positive Affect Treatment | Sheehan Disability Scale (SDS) | Week 16 | 9.56 score on a scale | Standard Deviation 6.64 |
| Negative Affect Treatment | Sheehan Disability Scale (SDS) | Week 16 | 9.08 score on a scale | Standard Deviation 6.38 |
| Negative Affect Treatment | Sheehan Disability Scale (SDS) | Week 0 | 16.65 score on a scale | Standard Deviation 6.51 |
| Negative Affect Treatment | Sheehan Disability Scale (SDS) | Week 10 | 11.86 score on a scale | Standard Deviation 6.94 |
| Negative Affect Treatment | Sheehan Disability Scale (SDS) | Week 5 | 14.84 score on a scale | Standard Deviation 6.97 |
Secondary
Temporal Experience of Pleasure Scale (Consummatory Subscale)
Mediator: Reported reward consummatory pleasure (score range: 8-48), with higher scores indicating higher reported reward consummatory pleasure
Time frame: Week 0, Week 5, Week 10, Week 16
Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Positive Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 0 | 35.81 score on a scale | Standard Deviation 6.98 |
| Positive Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 5 | 36.28 score on a scale | Standard Deviation 6.2 |
| Positive Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 10 | 37.03 score on a scale | Standard Deviation 6.17 |
| Positive Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 16 | 37.70 score on a scale | Standard Deviation 4.73 |
| Negative Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 16 | 37.62 score on a scale | Standard Deviation 5.59 |
| Negative Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 0 | 37.12 score on a scale | Standard Deviation 6.03 |
| Negative Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 10 | 37.97 score on a scale | Standard Deviation 5.17 |
| Negative Affect Treatment | Temporal Experience of Pleasure Scale (Consummatory Subscale) | Week 5 | 37.49 score on a scale | Standard Deviation 5.83 |
Comparison: This analysis compares the PAT and NAT groups at post-treatment. For this analysis, we have greater than .80 power to detect an effect size difference as small as d=.39.p-value: 0.231Mixed Models Analysis