Affect Treatment for Depression and Anxiety

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05203861
• Other study ID #: R33MH115138
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: Shawn Wang, B.A.
• Phone: (209) 800-8930
• Email: shawnwang[@]psych.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Affect Schedule Expanded (PANAS-X) (General Dimensions Scales)	Reported positive affect (general dimensions scale positive affect) and negative affect (general dimension scale negative affect) (score range for each scale: 10-50, higher scores represent higher levels of positive affect or negative affect).	Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Primary	Depression Anxiety and Stress Scale (DASS-21)	Reported symptoms of depression (score range: 0-21), anxiety (score range: 0-21), and stress (score range: 0-21), higher scores indicate higher severity and frequency.	Baseline to post-treatment (16 weeks) and follow-up (20 weeks)
Secondary	Interviewer Anhedonia Ratings	Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia	Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
Secondary	Sheehan Disability Scale (SDS)	Reported impairment due to symptoms (score range: 0-30) with higher scores indicating greater impairment. Includes reported number of days of missed school/work and number of days of reduced productivity.	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Beck Scale for Suicide Ideation	Reported suicidal ideation (score range: 0-38), higher scores indicate higher suicidality	Baseline, post-treatment (16 weeks) and follow-up (20 weeks)
Secondary	Positive and Negative Affect Schedule Expanded (PANAS-X) Basic Positive Emotions Scales and Serenity	Mediator: Reported positive affect (basic positive emotions scales and serenity) (score range: 19 - 95). Note: items which overlap with the general dimensions scale for positive affect (see Outcome 1) will not be included in this composite score. Excluded overlapping items include: alert, attentive, determined, enthusiastic, excited, proud, and strong.	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Effort-Expenditure for Rewards Task (EEfRT)	Mediator: behavioral effort for reward	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Monetary Incentive Task	Mediator: cardiac acceleration to anticipation of reward	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)	Mediator: Reported reward sensitivity (score range: 4-16), and threat sensitivity (score range: 7-28), with higher scores indicating higher sensitivity	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Dimensional Anhedonia Rating Scale	Mediator: Reported reward desire, motivation, effort, and pleasure (score range: 0-68), with higher scores indicating higher degree of reward desire, motivation, effort, and pleasure	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Modified Attentional Dot Probe Task	Mediator: attentional engagement with positive and negative stimuli	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	International Affective Picture System Task	Mediator: cardiac response to positive stimuli	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Temporal Experience of Pleasure Scale (consummatory subscale)	Mediator: Reported reward consummatory pleasure (score range: 8-48)	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Anxiety Sensitivity Index	Mediator: Reported threat appraisal of anxiety (score range: 0-64)	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Probability and Cost Questionnaire for Social and Physical Outcomes	Mediator: Reported threat appraisal of social and physical outcomes (score range: 0-80 for each subscale), with higher scores indicating higher cost/probability estimation	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)
Secondary	Mental Arithmetic Task	Mediator: cardiorespiratory response to stress	Baseline, Week 5, Week 10, post-treatment (Week 16) and follow-up (Week 20)