Treatment for Affect Dimensions

NCT03439748 | Completed Results DMC

• 1 other identifier: R61MH115138
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)

  Reported positive affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect.

  Week 0, Week 5, Week 10, Week 16

• 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.

  Week 0, Week 5, Week 10, Week 16

• Depression Anxiety and Stress Scale (DASS-21)

  Reported symptoms of depression, anxiety, and stress (score range: 0-63), higher scores indicate higher symptom severity and frequency.

  Week 0, Week 5, Week 10, Week 16

Secondary Outcomes (15)

• Sheehan Disability Scale (SDS)

  Week 0, Week 5, Week 10, Week 16

• Beck Depression Inventory (BDI)

  Week 0, Week 5, Week 10, Week 16

• Daily Activity/Social Interaction (Actigraph)

  Week 0, Week 5, Week 10, Week 16

• Effort Expenditure for Rewards Task (EEfRT)

  Week 0, Week 5, Week 10, Week 16

• Monetary Incentive Task

  Week 0, Week 5, Week 10, Week 16

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, mental retardation, or organic brain damage
• Substance abuse in the last 6 months or dependence within last 12 months.
• or more 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)
• Pregnancy
• Bupropion, dopaminergic or neuroleptic medication 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

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

Related Publications (2)

• Uribe S, Kumar D, Rosenfield D, Ritz T, Meuret AE. From in-person to virtual: The impact of crisis-enforced delivery change on treatment for low positive affect, depression, and anxiety. J Affect Disord. 2025 Dec 15;391:119864. doi: 10.1016/j.jad.2025.119864. Epub 2025 Jul 11.

  PMID: 40652976 DERIVED

• Craske MG, Meuret AE, Echiverri-Cohen A, Rosenfield D, Ritz T. Positive affect treatment targets reward sensitivity: A randomized controlled trial. J Consult Clin Psychol. 2023 Jun;91(6):350-366. doi: 10.1037/ccp0000805. Epub 2023 Mar 9.

  PMID: 36892884 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

Generalizability from academic to community settings; Sample was selected to have low positive affect, thus results may not generalize to samples diagnosed with anhedonia; Lack of follow-up assessment prevented evaluation of long-term changes in target measures and outcomes; Sample powered for moderate or larger effects, while smaller effects may require larger samples; Participants not blinded to condition; NAT was not representative of typical cognitive-behavioral therapy for depression.

Results Point of Contact

• Title: Dr. Michelle G. Craske
• Organization: UCLA

mcraske@mednet.ucla.edu

(310) 825-8403

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 5, 2018
• First Posted: February 20, 2018
• Study Start: February 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 12, 2024
• Results First Posted: December 7, 2023

Record last verified: 2024-06

Locations

US (2)