Affect Treatment for Depression and Anxiety (TAD Pilot)

NCT06488859 | Completed DMC

• 1 other identifier: TAD Pilot
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Interviewer Anhedonia Ratings

  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)

  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)

  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)

  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)

  Baseline (week 1), pre-treatment (week 2), mid-treatment (week 6), post-treatment (week 11/week 16, depending on treatment condition)

Study Arms (2)

Positive Affect Treatment

EXPERIMENTAL

8 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

Behavioral: Positive Affect Treatment

Positive Affect Treatment and Negative Affect Treatment

ACTIVE COMPARATOR

8 sessions of psychotherapy. 3-5 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning. Remaining sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.

Behavioral: Positive Affect Treatment and Negative Affect Treatment

Interventions

Positive Affect Treatment BEHAVIORAL

Sessions 1-8: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects

Positive Affect Treatment

Positive Affect Treatment and Negative Affect Treatment BEHAVIORAL

Sessions 1-4: Pleasurable activities + imaginal recounting and reinforcement of positive mood effects Sessions 5-8: Exposure therapy to feared or avoided situations, sensations, or memories

Positive Affect Treatment and Negative Affect Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and greater to or equal to 6 for anxiety on the Depression, Anxiety, and Stress Scale.
• Score of greater than or equal to 4 on any WSAS subscale
• Willingness to refrain from starting other psychosocial or pharmacological treatments until study completion.

You may not qualify if:

• 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)
• Current active suicidal ideation
• Lifetime history of bipolar disorder, psychosis, cognitive impairment, or organic brain damage
• Substance use disorder (including smoking) within the last 6 months. History of cocaine or stimulate use (e.g., amphetamine, cocaine, methamphetamine)
• Greater than 11 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)
• Willingness to refrain from marijuana use 1 week before laboratory assessments
• Pregnancy
• Bupropion, dopaminergic or neuroleptic medications 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
• Prior participation in previous waves of this study

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Southern Methodist University: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Southern Methodist University

Dallas, Texas, 75205, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 5, 2024
• Study Start: March 25, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (2)