Clinical trial NCT03439748: Treatment for Affect Dimensions
Official title: Reward Sensitivity as a Mechanism of Positive Affect Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Southern Methodist University
First posted: 2018-02-20
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Interviewer Anhedonia Ratings
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Week 0, Week 5, Week 10, Week 16
Secondary outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Beck Depression Inventory (BDI)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Daily Activity/Social Interaction (Actigraph)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Effort Expenditure for Rewards Task (EEfRT)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Monetary Incentive Task
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Behavioral Inhibition/Behavioral Activation (Reward Drive Subscale) (BAS-RD)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Dimensional Anhedonia Rating Scale-Anticipation and Motivation Items
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Dimensional Anhedonia Rating Scale-Consummatory Items
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Modified Attentional Dot Probe Task-Disengagement Bias for Negative Stimuli
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Modified Attentional Dot Probe Task-Engagement Bias for Positive Stimuli
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: International Affective Picture System Task
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Temporal Experience of Pleasure Scale (Consummatory Subscale)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Probabilistic Reward Task (PRT)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Pavlovian Instrumental Transfer Task - Force (PIT-FORCE)
timeFrame: Week 0, Week 5, Week 10, Week 16
measure: Pavlovian Instrumental Transfer Task - Valence (PIT-VALENCE)
timeFrame: Week 0, Week 5, Week 10, Week 16
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
References: