Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of California, Los Angeles

Study Contact

Shawn Wang, B.A.
(209) 800-8930
shawnwang@psych.ucla.edu

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 a replication and extension of a prior NIMH funded R61 phase trial, the purpose of this R33 phase randomized controlled trial is to evaluate the efficacy and mediators of change of Positive Affect Treatment (designed to augment reward sensitivity) for individuals with low positive affect in the context of depression or anxiety symptoms. Mediators (targets) include behavioral, cognitive, physiological and experiential measures of two reward targets: reward anticipation and response to reward attainment. Specificity of target engagement is assessed by comparison with Negative Affect Treatment, designed to reduce threat sensitivity, and by including behavioral, cognitive, physiological and experiential mediators (targets) that assess threat sensitivity. Clinical outcomes are assessed at baseline and either weekly or at Week 5, Week 10, Week 16 (post), and one-month follow-up. Mediators (targets) are assessed at baseline, Week 5, Week 10, Week 16 (post) and one-month follow-up. Mediational models will evaluate the degree to which change in the target measures explain change in the outcome measures. 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 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 5 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.