Treatment for Affect Dimensions (TAD)

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Depression
Anxiety

Treatments

Behavioral: Positive Affect Treatment
Behavioral: Negative Affect Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03439748
R61MH115138

Details and patient eligibility

About

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.

Full 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 an NIMH funded R61 phase trial, the purpose of the current randomized controlled trial is to evaluate the efficacy and targets of Positive Affect Treatment (designed to augment reward sensitivity) for individuals with low positive affect in the context of depression or anxiety symptoms. Targets include behavioral, cognitive, physiological and experiential measures of three reward processes: reward anticipation, response to reward attainment, and reward learning. Specificity of target engagement is assessed by comparison with Negative Affect Treatment, designed to reduce threat sensitivity. Clinical outcomes are assessed at baseline and either weekly or at Week 5, Week 10, and Week 15 (post). Targets are assessed at baseline, Week 5, Week 10, and Week 15. Statistical models evaluate whether change in outcomes and change in target measures are greater as a result of Positive Affect Treatment compared to Negative Affect Treatment and whether changes in target measures correlate with changes in outcome measures. 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 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 4 months.

Enrollment

85 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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, mental retardation, or organic brain damage
  • Substance abuse in the last 6 months or dependence within last 12 months.
  • 11 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

85 participants in 2 patient groups

Positive Affect Treatment
Experimental group
Description:
15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.
Treatment:
Behavioral: Positive Affect Treatment
Negative Affect Treatment
Active Comparator group
Description:
15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.
Treatment:
Behavioral: Negative Affect Treatment

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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