Clinical trial NCT05203861: Affect Treatment for Depression and Anxiety
Official title: Reward and Threat Sensitivity as Mediators of Positive and Negative 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: 2022-01-24
Enrollment: 100
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 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.

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.

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, 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

Primary outcomes:
measure: Positive and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales)
timeFrame: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
measure: Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Secondary outcomes:
measure: Interviewer Anhedonia Ratings
timeFrame: Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Beck Scale for Suicide Ideation
timeFrame: Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
measure: Positive and Negative Affect Schedule Expanded (PANAS-X) Basic Positive Emotions Scales and Serenity
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Effort-Expenditure for Rewards Task (EEfRT)
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Monetary Incentive Task
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Dimensional Anhedonia Rating Scale
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Modified Attentional Dot Probe Task
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: International Affective Picture System Task
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Temporal Experience of Pleasure Scale (consummatory subscale)
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Anxiety Sensitivity Index
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Probability and Cost Questionnaire for Social and Physical Outcomes
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
measure: Mental Arithmetic Task
timeFrame: Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
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: