Trial Outcomes & Findings for Treatment for Affect Dimensions (NCT NCT03439748)
NCT ID: NCT03439748
Last Updated: 2024-06-12
Results Overview
Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
Week 0, Week 5, Week 10, Week 16
Results posted on
2024-06-12
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
Week 5 Assessment
|
36
|
37
|
|
Overall Study
Week 10 Assessment
|
32
|
29
|
|
Overall Study
COMPLETED
|
31
|
26
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
17
|
Baseline Characteristics
Treatment for Affect Dimensions
Baseline characteristics by cohort
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.95 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
31.51 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
31.73 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Alaska Native/Native American/Indigenous
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander/Native Hawaiian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino (White)
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino (non-White)
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital status
Married
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Marital status
Single, in a relationship
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Marital status
Single, not in a relationship
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Marital status
Separated
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital status
Divorced
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Current psychotropic medication
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Any diagnosis
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Depressive diagnoses
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Major depressive disorder
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Persistent depressive disorder
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Anxiety diagnoses
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Panic disorder
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Agoraphobia
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Social anxiety disorder
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Generalized anxiety disorder
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Specific phobia
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Posttraumatic stress disorder
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Obsessive compulsive disorder
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Attention deficit hyperactivity
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Adjustment disorder
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Week 0
|
20.76 score on a scale
Standard Deviation 7.42
|
29.42 score on a scale
Standard Deviation 4.74
|
|
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Week 5
|
24.18 score on a scale
Standard Deviation 7.37
|
19.42 score on a scale
Standard Deviation 8.12
|
|
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Week 10
|
26.88 score on a scale
Standard Deviation 8.29
|
22.57 score on a scale
Standard Deviation 9.82
|
|
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Week 16
|
27.30 score on a scale
Standard Deviation 7.23
|
23.85 score on a scale
Standard Deviation 9.28
|
PRIMARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Interviewer Anhedonia Ratings
Week 0
|
7.66 score on a scale
Standard Deviation 2.13
|
7.47 score on a scale
Standard Deviation 1.80
|
|
Interviewer Anhedonia Ratings
Week 5
|
6.11 score on a scale
Standard Deviation 2.26
|
5.49 score on a scale
Standard Deviation 2.40
|
|
Interviewer Anhedonia Ratings
Week 10
|
4.91 score on a scale
Standard Deviation 2.19
|
4.93 score on a scale
Standard Deviation 2.40
|
|
Interviewer Anhedonia Ratings
Week 16
|
4.19 score on a scale
Standard Deviation 1.47
|
4.43 score on a scale
Standard Deviation 2.23
|
PRIMARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Depression Anxiety and Stress Scale (DASS-21)
Week 0
|
27.36 score on a scale
Standard Deviation 11.27
|
24.51 score on a scale
Standard Deviation 10.54
|
|
Depression Anxiety and Stress Scale (DASS-21)
Week 5
|
17.90 score on a scale
Standard Deviation 11.56
|
17.92 score on a scale
Standard Deviation 10.51
|
|
Depression Anxiety and Stress Scale (DASS-21)
Week 10
|
11.55 score on a scale
Standard Deviation 9.60
|
13.00 score on a scale
Standard Deviation 12.13
|
|
Depression Anxiety and Stress Scale (DASS-21)
Week 16
|
9.09 score on a scale
Standard Deviation 6.85
|
12.38 score on a scale
Standard Deviation 10.90
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
Week 5
|
14.53 score on a scale
Standard Deviation 6.46
|
14.84 score on a scale
Standard Deviation 6.97
|
|
Sheehan Disability Scale (SDS)
Week 10
|
11.19 score on a scale
Standard Deviation 6.34
|
11.86 score on a scale
Standard Deviation 6.94
|
|
Sheehan Disability Scale (SDS)
Week 0
|
18.40 score on a scale
Standard Deviation 6.14
|
16.65 score on a scale
Standard Deviation 6.51
|
|
Sheehan Disability Scale (SDS)
Week 16
|
9.56 score on a scale
Standard Deviation 6.64
|
9.08 score on a scale
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Beck Depression Inventory (BDI)
Week 10
|
0.18 score on a scale
Standard Deviation 0.39
|
0.20 score on a scale
Standard Deviation 0.41
|
|
Beck Depression Inventory (BDI)
Week 16
|
0.23 score on a scale
Standard Deviation 0.43
|
0.08 score on a scale
Standard Deviation 0.27
|
|
Beck Depression Inventory (BDI)
Week 0
|
0.17 score on a scale
Standard Deviation 0.38
|
0.23 score on a scale
Standard Deviation 0.43
|
|
Beck Depression Inventory (BDI)
Week 5
|
0.18 score on a scale
Standard Deviation 0.39
|
0.14 score on a scale
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=15 Participants
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.
|
Negative Affect Treatment
n=14 Participants
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
|
|---|---|---|
|
Daily Activity/Social Interaction (Actigraph)
Week 0
|
40.212 kcals expended per hour
Standard Deviation 19.677
|
34.634 kcals expended per hour
Standard Deviation 24.427
|
|
Daily Activity/Social Interaction (Actigraph)
Week 5
|
41.98 kcals expended per hour
Standard Deviation 20.58
|
41.44 kcals expended per hour
Standard Deviation 26.06
|
|
Daily Activity/Social Interaction (Actigraph)
Week 10
|
34.21 kcals expended per hour
Standard Deviation 20.75
|
46.92 kcals expended per hour
Standard Deviation 29.33
|
|
Daily Activity/Social Interaction (Actigraph)
Week 16
|
43.69 kcals expended per hour
Standard Deviation 27.13
|
56.57 kcals expended per hour
Standard Deviation 53.04
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Effort Expenditure for Rewards Task (EEfRT)
Week 0
|
0.41 proportion of high effort choices
Standard Deviation 0.20
|
0.41 proportion of high effort choices
Standard Deviation 0.27
|
|
Effort Expenditure for Rewards Task (EEfRT)
Week 5
|
0.43 proportion of high effort choices
Standard Deviation 0.22
|
0.39 proportion of high effort choices
Standard Deviation 0.23
|
|
Effort Expenditure for Rewards Task (EEfRT)
Week 10
|
0.51 proportion of high effort choices
Standard Deviation 0.26
|
0.41 proportion of high effort choices
Standard Deviation 0.31
|
|
Effort Expenditure for Rewards Task (EEfRT)
Week 16
|
0.48 proportion of high effort choices
Standard Deviation 0.29
|
0.42 proportion of high effort choices
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Monetary Incentive Task
Week 0
|
-0.012 beats/ms^2
Standard Deviation 0.512
|
-0.017 beats/ms^2
Standard Deviation 0.046
|
|
Monetary Incentive Task
Week 5
|
0.017 beats/ms^2
Standard Deviation 0.048
|
0.013 beats/ms^2
Standard Deviation 0.061
|
|
Monetary Incentive Task
Week 10
|
-0.002 beats/ms^2
Standard Deviation 0.042
|
0.004 beats/ms^2
Standard Deviation 0.043
|
|
Monetary Incentive Task
Week 16
|
0.003 beats/ms^2
Standard Deviation 0.026
|
0.026 beats/ms^2
Standard Deviation 0.053
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
Week 0
|
9.67 score on a scale
Standard Deviation 2.63
|
9.42 score on a scale
Standard Deviation 2.21
|
|
Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
Week 5
|
10.50 score on a scale
Standard Deviation 2.63
|
10.14 score on a scale
Standard Deviation 2.26
|
|
Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
Week 10
|
10.66 score on a scale
Standard Deviation 2.51
|
10.66 score on a scale
Standard Deviation 2.36
|
|
Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
Week 16
|
10.30 score on a scale
Standard Deviation 2.56
|
11.08 score on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Mediator: Reported reward desire, motivation, and effort (score range: 0-76) with higher scores indicating higher degree of reward desire, motivation, and effort.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
Week 0
|
42.85 score on a scale
Standard Deviation 16.96
|
49.16 score on a scale
Standard Deviation 16.32
|
|
Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
Week 5
|
52.28 score on a scale
Standard Deviation 14.20
|
52.46 score on a scale
Standard Deviation 15.36
|
|
Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
Week 10
|
55.63 score on a scale
Standard Deviation 15.69
|
55.66 score on a scale
Standard Deviation 16.08
|
|
Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
Week 16
|
59.84 score on a scale
Standard Deviation 14.31
|
58.46 score on a scale
Standard Deviation 16.31
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Mediator: Reported reward-related pleasure (score range: 0-28), with higher scores indicating higher degree of pleasure.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Dimensional Anhedonia Rating Scale-Consummatory Items
Week 0
|
17.56 score on a scale
Standard Deviation 6.26
|
19.12 score on a scale
Standard Deviation 6.16
|
|
Dimensional Anhedonia Rating Scale-Consummatory Items
Week 5
|
20.39 score on a scale
Standard Deviation 4.76
|
20.51 score on a scale
Standard Deviation 6.25
|
|
Dimensional Anhedonia Rating Scale-Consummatory Items
Week 10
|
21.50 score on a scale
Standard Deviation 5.66
|
21.59 score on a scale
Standard Deviation 5.99
|
|
Dimensional Anhedonia Rating Scale-Consummatory Items
Week 16
|
22.88 score on a scale
Standard Deviation 4.73
|
22.12 score on a scale
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
Week 0
|
-43.43 milliseconds (ms)
Standard Deviation 114.62
|
2.80 milliseconds (ms)
Standard Deviation 105.63
|
|
Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
Week 5
|
16.70 milliseconds (ms)
Standard Deviation 98.11
|
-16.49 milliseconds (ms)
Standard Deviation 102.44
|
|
Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
Week 10
|
-3.07 milliseconds (ms)
Standard Deviation 82.01
|
-31.56 milliseconds (ms)
Standard Deviation 94.05
|
|
Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
Week 16
|
4.85 milliseconds (ms)
Standard Deviation 97.00
|
66.24 milliseconds (ms)
Standard Deviation 101.47
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
Week 0
|
9.30 milliseconds (ms)
Standard Deviation 105.87
|
3.29 milliseconds (ms)
Standard Deviation 108.57
|
|
Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
Week 5
|
-17.65 milliseconds (ms)
Standard Deviation 90.72
|
2.62 milliseconds (ms)
Standard Deviation 96.57
|
|
Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
Week 10
|
-20.86 milliseconds (ms)
Standard Deviation 69.89
|
-22.51 milliseconds (ms)
Standard Deviation 88.93
|
|
Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
Week 16
|
-22.51 milliseconds (ms)
Standard Deviation 89.93
|
16.36 milliseconds (ms)
Standard Deviation 111.56
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
International Affective Picture System Task
Week 0
|
0.0003 beats/ms^2
Standard Deviation 0.0243
|
-0.0007 beats/ms^2
Standard Deviation 0.0238
|
|
International Affective Picture System Task
Week 5
|
-0.0016 beats/ms^2
Standard Deviation 0.0222
|
-0.0061 beats/ms^2
Standard Deviation 0.0331
|
|
International Affective Picture System Task
Week 10
|
0.0071 beats/ms^2
Standard Deviation 0.0221
|
0.0013 beats/ms^2
Standard Deviation 0.0244
|
|
International Affective Picture System Task
Week 16
|
0.0024 beats/ms^2
Standard Deviation 0.0222
|
0.0035 beats/ms^2
Standard Deviation 0.0524
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
Mediator: Reported reward consummatory pleasure (score range: 8-48), with higher scores indicating higher reported reward consummatory pleasure
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Temporal Experience of Pleasure Scale (Consummatory Subscale)
Week 16
|
37.70 score on a scale
Standard Deviation 4.73
|
37.62 score on a scale
Standard Deviation 5.59
|
|
Temporal Experience of Pleasure Scale (Consummatory Subscale)
Week 0
|
35.81 score on a scale
Standard Deviation 6.98
|
37.12 score on a scale
Standard Deviation 6.03
|
|
Temporal Experience of Pleasure Scale (Consummatory Subscale)
Week 5
|
36.28 score on a scale
Standard Deviation 6.20
|
37.49 score on a scale
Standard Deviation 5.83
|
|
Temporal Experience of Pleasure Scale (Consummatory Subscale)
Week 10
|
37.03 score on a scale
Standard Deviation 6.17
|
37.97 score on a scale
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Probabilistic Reward Task (PRT)
Week 0
|
0.16 Ratio
Standard Deviation 0.19
|
0.15 Ratio
Standard Deviation 0.29
|
|
Probabilistic Reward Task (PRT)
Week 5
|
0.04 Ratio
Standard Deviation 0.27
|
0.19 Ratio
Standard Deviation 0.27
|
|
Probabilistic Reward Task (PRT)
Week 10
|
0.09 Ratio
Standard Deviation 0.13
|
0.03 Ratio
Standard Deviation 0.18
|
|
Probabilistic Reward Task (PRT)
Week 16
|
0.16 Ratio
Standard Deviation 0.21
|
0.15 Ratio
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
Week 0
|
6.30 volts
Standard Deviation 12.29
|
4.91 volts
Standard Deviation 13.54
|
|
Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
Week 5
|
7.96 volts
Standard Deviation 15.61
|
6.72 volts
Standard Deviation 12.60
|
|
Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
Week 10
|
6.55 volts
Standard Deviation 16.39
|
6.57 volts
Standard Deviation 12.35
|
|
Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
Week 16
|
8.05 volts
Standard Deviation 16.34
|
1.24 volts
Standard Deviation 7.96
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 16Population: Intent to treat population (all participants assigned to Positive Affect Treatment or Negative Affect Treatment)
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.
Outcome measures
| Measure |
Positive Affect Treatment
n=42 Participants
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.
|
Negative Affect Treatment
n=43 Participants
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
|
|---|---|---|
|
Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
Week 0
|
1.09 score on a scale
Standard Deviation 2.10
|
0.62 score on a scale
Standard Deviation 2.17
|
|
Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
Week 5
|
1.50 score on a scale
Standard Deviation 2.50
|
0.73 score on a scale
Standard Deviation 2.99
|
|
Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
Week 10
|
1.29 score on a scale
Standard Deviation 2.88
|
0.44 score on a scale
Standard Deviation 2.94
|
|
Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
Week 16
|
0.74 score on a scale
Standard Deviation 2.49
|
1.93 score on a scale
Standard Deviation 1.90
|
Adverse Events
Positive Affect Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Negative Affect Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Positive Affect Treatment
n=42 participants at risk
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.
|
Negative Affect Treatment
n=43 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Clinical deterioration
|
0.00%
0/42 • Each participant was assessed over 16 weeks
DSMB committee members independently evaluated whether each event qualified as a serious adverse event using the following criteria: 1) Serious/Not serious: Is the event serious or places subjects or others at greater risk than previously known or recognized? 2) Expected/Unexpected: Is the event unexpected (not described in the protocol or consent or exceeds severity/frequency of expected event) 3) Causality: Is the event-related or possibly related to research procedures?
|
4.7%
2/43 • Number of events 2 • Each participant was assessed over 16 weeks
DSMB committee members independently evaluated whether each event qualified as a serious adverse event using the following criteria: 1) Serious/Not serious: Is the event serious or places subjects or others at greater risk than previously known or recognized? 2) Expected/Unexpected: Is the event unexpected (not described in the protocol or consent or exceeds severity/frequency of expected event) 3) Causality: Is the event-related or possibly related to research procedures?
|
|
Psychiatric disorders
Homework noncompliance leading to participant withdrawal
|
0.00%
0/42 • Each participant was assessed over 16 weeks
DSMB committee members independently evaluated whether each event qualified as a serious adverse event using the following criteria: 1) Serious/Not serious: Is the event serious or places subjects or others at greater risk than previously known or recognized? 2) Expected/Unexpected: Is the event unexpected (not described in the protocol or consent or exceeds severity/frequency of expected event) 3) Causality: Is the event-related or possibly related to research procedures?
|
2.3%
1/43 • Number of events 1 • Each participant was assessed over 16 weeks
DSMB committee members independently evaluated whether each event qualified as a serious adverse event using the following criteria: 1) Serious/Not serious: Is the event serious or places subjects or others at greater risk than previously known or recognized? 2) Expected/Unexpected: Is the event unexpected (not described in the protocol or consent or exceeds severity/frequency of expected event) 3) Causality: Is the event-related or possibly related to research procedures?
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place