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Treatment for Affect Dimensions (TAD)

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Affect Treatment
Negative Affect Treatment
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, Los Angeles
  • Southern Methodist University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Positive Affect Treatment

Negative Affect Treatment

Arm Description

15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.

15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.

Outcomes

Primary Outcome Measures

Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Change in reported positive affect
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
Depression Anxiety and Stress Scale (DASS)
Change in reported symptoms of depression, anxiety, and stress

Secondary Outcome Measures

Sheehan Disability Scale (SDS)
Change in daily functioning
Beck Depression Inventory (BDI)
Change in reported suicidal ideation
Daily activity/social interaction (Actigraph)
Change in social interaction
Effort Expenditure for Rewards Task (EEfRT)
Mediator: behavioral effort for reward
Monetary Incentive Task
Mediator: cardiac acceleration to anticipation of reward
Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity
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
Modified Attentional Dot Probe Task
Mediator: attentional engagement with positive and negative stimuli
International Affective Picture System Task
Mediator: cardiac response to positive stimuli
Temporal Experience of Pleasure Scale (consummatory subscale)
Mediator: Reported reward consummatory pleasure (score range: 8-48)
Probabilistic Reward Task (PRT)
Mediator: Change in reward learning
Pavlovian Instrumental Transfer Task (PIT-FORCE and PIT-VALENCE)
Mediator: Change in force and valence for stimuli associated with reward

Full Information

First Posted
February 5, 2018
Last Updated
April 18, 2022
Sponsor
University of California, Los Angeles
Collaborators
Southern Methodist University
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1. Study Identification

Unique Protocol Identification Number
NCT03439748
Brief Title
Treatment for Affect Dimensions
Acronym
TAD
Official Title
Reward Sensitivity as a Mechanism of Positive Affect Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Southern Methodist University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Affect Treatment
Arm Type
Experimental
Arm Description
15 sessions of psychotherapy designed to augment reward anticipation, reward attainment, and reward learning.
Arm Title
Negative Affect Treatment
Arm Type
Active Comparator
Arm Description
15 sessions of psychotherapy designed to decrease threat avoidance, threat appraisal and arousal.
Intervention Type
Behavioral
Intervention Name(s)
Positive Affect Treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Negative Affect Treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P)
Description
Change in reported positive affect
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Interviewer Anhedonia Ratings
Description
Interviewer ratings of interest, pleasure, and motivation in hobbies/pastimes, foods/drinks, social activities (score range: 1-12), higher scores indicate lower anhedonia
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Depression Anxiety and Stress Scale (DASS)
Description
Change in reported symptoms of depression, anxiety, and stress
Time Frame
Change from baseline to post-treatment (15 weeks)
Secondary Outcome Measure Information:
Title
Sheehan Disability Scale (SDS)
Description
Change in daily functioning
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Beck Depression Inventory (BDI)
Description
Change in reported suicidal ideation
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Daily activity/social interaction (Actigraph)
Description
Change in social interaction
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Effort Expenditure for Rewards Task (EEfRT)
Description
Mediator: behavioral effort for reward
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Monetary Incentive Task
Description
Mediator: cardiac acceleration to anticipation of reward
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Behavioral Inhibition/Behavioral Activation (reward drive subscale) (BAS-RD)
Description
Mediator: Reported reward sensitivity (score range: 4-16), with higher scores indicating higher sensitivity
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Dimensional Anhedonia Rating Scale
Description
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
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Modified Attentional Dot Probe Task
Description
Mediator: attentional engagement with positive and negative stimuli
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
International Affective Picture System Task
Description
Mediator: cardiac response to positive stimuli
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Temporal Experience of Pleasure Scale (consummatory subscale)
Description
Mediator: Reported reward consummatory pleasure (score range: 8-48)
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Probabilistic Reward Task (PRT)
Description
Mediator: Change in reward learning
Time Frame
Change from baseline to post-treatment (15 weeks)
Title
Pavlovian Instrumental Transfer Task (PIT-FORCE and PIT-VALENCE)
Description
Mediator: Change in force and valence for stimuli associated with reward
Time Frame
Change from baseline to post-treatment (15 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75205
Country
United States

12. IPD Sharing Statement

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Treatment for Affect Dimensions

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