Affect Treatment for Depression and Anxiety

NCT05203861 | Completed DMC

• 1 other identifier: R33MH115138
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy and mediators of change in 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 100 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 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 to post-treatment (16 weeks) and follow-up (20 weeks)

• 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 to post-treatment (16 weeks) and follow-up (20 weeks)

Secondary Outcomes (14)

• Interviewer Anhedonia Ratings

  Baseline, post-treatment (16 weeks) and follow-up (20 weeks)

• Sheehan Disability Scale (SDS)

  Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)

• Beck Scale for Suicide Ideation

  Baseline, post-treatment (16 weeks) and follow-up (20 weeks)

• Positive and Negative Affect Schedule Expanded (PANAS-X) Basic Positive Emotions Scales and Serenity

  Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)

• Effort-Expenditure for Rewards Task (EEfRT)

  Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)

Study Arms (2)

Positive Affect Treatment

EXPERIMENTAL

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

Behavioral: Positive Affect Treatment

Negative Affect Treatment

ACTIVE COMPARATOR

15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.

Behavioral: Negative Affect Treatment

Interventions

Positive Affect Treatment BEHAVIORAL

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.

Positive Affect Treatment

Negative Affect Treatment BEHAVIORAL

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

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, 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.

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)
• Active suicidal ideation
• Lifetime history of bipolar disorder, psychosis, cognitive impairment, or organic brain damage
• Substance abuse in the last 6 months or dependence within last 12 months.
• 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: January 10, 2022
• First Posted: January 24, 2022
• Study Start: November 22, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

US (2)