TAD: Treatment for Affect Dimensions
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Positive Affect Treatment 15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. |
Behavioral: 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.
|
| Active Comparator: Negative Affect Treatment 15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal. |
Behavioral: 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
|
Outcome Measures
Primary Outcome Measures
- Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) [Change from baseline to post-treatment (15 weeks)]
Change in reported positive affect
- Interviewer Anhedonia Ratings [Change from baseline to post-treatment (15 weeks)]
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) [Change from baseline to post-treatment (15 weeks)]
Change in reported symptoms of depression, anxiety, and stress
Secondary Outcome Measures
- Sheehan Disability Scale (SDS) [Change from baseline to post-treatment (15 weeks)]
Change in daily functioning
- Beck Depression Inventory (BDI) [Change from baseline to post-treatment (15 weeks)]
Change in reported suicidal ideation
- Daily activity/social interaction (Actigraph) [Change from baseline to post-treatment (15 weeks)]
Change in social interaction
- Effort Expenditure for Rewards Task (EEfRT) [Change from baseline to post-treatment (15 weeks)]
Mediator: behavioral effort for reward
- Monetary Incentive Task [Change from baseline to post-treatment (15 weeks)]
Mediator: cardiac acceleration to anticipation of reward
- Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD) [Change from baseline to post-treatment (15 weeks)]
Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity
- Dimensional Anhedonia Rating Scale [Change from baseline to post-treatment (15 weeks)]
Mediator: Reported reward desire, motivation, effort, and pleasure (score range: 0-68), with higher scores indicating higher degree of reward desire, motivation, effort, and pleasure
- Modified Attentional Dot Probe Task [Change from baseline to post-treatment (15 weeks)]
Mediator: attentional engagement with positive and negative stimuli
- International Affective Picture System Task [Change from baseline to post-treatment (15 weeks)]
Mediator: cardiac response to positive stimuli
- Temporal Experience of Pleasure Scale (consummatory subscale) [Change from baseline to post-treatment (15 weeks)]
Mediator: Reported reward consummatory pleasure (score range: 8-48)
- Probabilistic Reward Task (PRT) [Change from baseline to post-treatment (15 weeks)]
Mediator: Change in reward learning
- Pavlovian Instrumental Transfer Task (PIT-FORCE and PIT-VALENCE) [Change from baseline to post-treatment (15 weeks)]
Mediator: Change in force and valence for stimuli associated with reward
Eligibility Criteria
Criteria
Inclusion Criteria:
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English-speaking
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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.
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Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.
Exclusion Criteria:
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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)
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Active suicidal ideation
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Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage
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Substance abuse in the last 6 months or dependence within last 12 months.
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11 or more cigarettes per week or nicotine equivalent.
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History of marijuana, cocaine or stimulant use 5-7 times/week or more before age 15 (e.g., amphetamine, cocaine, methamphetamine)
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Pregnancy
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Bupropion, dopaminergic or neuroleptic medication use in the past 6 months
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Heterocyclics and SSRIs are permitted if stabilized (3 months) and PRN benzodiazepines and beta-blockers are permitted but discouraged on laboratory assessment visits
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Refusal of video/audio-taping
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
| 2 | Southern Methodist University | Dallas | Texas | United States | 75205 |
Sponsors and Collaborators
- University of California, Los Angeles
- Southern Methodist University
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- R61MH115138