Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Michelle G. Craske, Ph.D

Description

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.

Official Title

Reward and Threat Sensitivity as Mediators of Positive and Negative Affect Treatment

Details

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.

Keywords

Depression, Anxiety, Depressive Disorder, Positive Affect Treatment, Negative Affect Treatment

Eligibility

You can join if…

Open to people ages 18-65

  • 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 CAN'T join 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

Locations

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Southern Methodist University accepting new patients
    Dallas Texas 75205 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05203861
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated