Affect Treatment for Depression and Anxiety (TAD Pilot)
NCT Number: NCT06488859
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Anxiety
Interventions: BEHAVIORAL: Positive Affect Treatment|BEHAVIORAL: Positive Affect Treatment and Negative Affect Treatment
Sponsor: University of California, Los Angeles
Collaborators: Southern Methodist University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-25
Completion Date: 2025-03-25
Locations: University of California, Los Angeles, Los Angeles, California, 90095, United States|Southern Methodist University, Dallas, Texas, 75205, United States

Summary:
The goal of this study is to determine whether subjects who do not show expected clinical improvement during the early course of positive affect treatment (PAT) would benefit from switching to an alternative psychosocial treatment (negative affect treatment) that is designed to instead target and improve deficits in 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 5 months.

Primary Outcome Measures: Positive and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales), Reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50), higher scores represent higher levels of positive affect or negative affect)., Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)|Depression Anxiety and Stress Scale (DASS-21), Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency., Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)
Secondary Outcome Measures: 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, Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)|Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD), Mediator: Reported reward sensitivity (score range: 4-16), and threat sensitivity (score range: 7-28), with higher scores indicating higher sensitivity, Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)|Beck Depression Inventory (BDI-9), Reported suicidal ideation (score range: 0-3), higher scores indicate higher suicidality, Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)|Temporal Experience of Pleasure Scale (TEPS), Change in reported anticipatory pleasure (score range: 10-60) and consummatory pleasure (score range: 8-48), higher scores indicate higher reward responsiveness, Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)|Dimensional Anhedonia Rating Scale (DARS), Reported desire, motivation, effort, and consummatory pleasure across hedonic domains (score range: 0-104), higher scores indicate lower anhedonia, Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)|Work and Social Adjustment Scale (WSAS), Reported impairment at work, home, and in relationships (score range: 0-40), higher scores indicate higher impairment, Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)