Treatment for Affect Dimensions (TAD)

• ClinicalTrials.gov Identifier: NCT03439748
• Recruitment Status: Recruiting
• First Posted: February 20, 2018
• Last Update Posted: November 26, 2021
• Sponsor: University of California, Los Angeles
• Collaborator: Southern Methodist University
• Information provided by (Responsible Party): Michelle Craske, University of California, Los Angeles

Study Description

Brief Summary:

Affect, or the tendency to experience a given emotion, often is subdivided into two domains. Positive affect is the tendency to experience positive emotions, such as happiness, excitement, elation, and enthusiasm. Negative affect is the tendency to experience negative emotions, such as anger, resentment, sadness, anxiety, and fear. Humans exhibit a range of emotions that span across positive and negative affect domains with some individuals experiencing more of one type of affect than another. Recent research and developing theories have suggested that mental health disorders can be conceptualized as the tendency for an individual to fall into one or more extremes on these categories. Therefore, treatments should not be based on targeting a conglomeration of symptoms (as we have been doing for the past century) but rather they should be treating the underlying dysregulation (e.g., high or low positive and negative affect).

In an effort to address this gap, the current study plans to recruit participants for a treatment trial consisting of two psychotherapies: (a) positive affect treatment (PAT), and (b) negative affect treatment (NAT). The overarching goal of this project are to evaluate the target (i.e. potential mechanisms) of PAT.

Participants will be randomized to either a 15-week positive (PAT) or negative affect treatment (NAT). Participants will also complete four laboratory visits (before treatment, during treatment (two times), and at post-treatment) to measure potential targets or mediators of PAT. These laboratory-based assessments will included measures of the positive affect system such as behavioral, subjective, and psychophysiological responses to reward, anticipation and motivation, reward attainment, and reward learning.

Condition or disease	Intervention/treatment	Phase
Anhedonia; Depression; Anxiety	Behavioral: Positive Affect Treatment; Behavioral: Negative Affect Treatment	Not Applicable

Detailed Description:

Anhedonia, or loss of interest or pleasure in usual activities, is characteristic of depression, some types of anxiety, as well as substance abuse and schizophrenia. Anhedonia is a predictor of poor long-term outcomes, including suicide, and poor treatment response. Extant psychological and pharmacological treatments are relatively ineffective for anhedonia. Thus, there is an unmet therapeutic need for this high-risk symptom. Recent advances in affective neuroscience have elucidated processes that may underlie anhedonia and should be targeted in therapy. Specifically, anhedonia is associated with deficits in the appetitive reward system, including (1) reward approach-motivation, (2) initial responsiveness to reward attainment, and (3) learning of reward. We have developed a novel transdiagnostic psychosocial treatment for anhedonia, Positive Affect Treatment (PAT), designed to improve deficits in reward sensitivity. The goal of the current study is to evaluate the targets of this new treatment, PAT, and whether the targets are specific to PAT relative to traditional cognitive behavioral therapy designed to reduce negative affect, called Negative Affect Treatment (NAT), in individuals with depression or anxiety.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Reward Sensitivity as a Mechanism of Positive Affect Treatment of Anhedonia
• Actual Study Start Date: November 1, 2018
• Estimated Primary Completion Date: July 30, 2022
• Estimated Study Completion Date: July 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Positive Affect Treatment; Sessions 1-7: Planning for engagement in pleasurable activities and reinforcement of positive mood effects of those activities Sessions 8-10: 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	Behavioral: Positive Affect Treatment; Sessions 1-7: Planning for engagement in pleasurable activities and reinforcement of positive mood effects of those activities Sessions 8-10: 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.
Active Comparator: Negative Affect Treatment; Sessions 1-7: Exposures to avoided scenarios Sessions 8-10: Cognitive restructuring Sessions 11-14: Normalization of arousal response to exposure Session 15: Relapse prevention	Behavioral: Negative Affect Treatment; Sessions 1-7: Exposures to avoided scenarios Sessions 8-10: Cognitive restructuring Sessions 11-14: Normalization of arousal response to exposure Session 15: Relapse prevention

Outcome Measures

Primary Outcome Measures :

1. Anhedonia: Positive Affect Subscale of the Positive and Negative Affect Scale (PANAS-P) and interviewer-rated anhedonia [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
   Change in reported positive affect
2. Depression Anxiety and Stress Scale (DASS) [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
   Change in reported symptoms of depression, anxiety, and stress

Secondary Outcome Measures :

1. Sheehan Disability Scale (SDS) [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
   Change in daily functioning
2. Beck Depression Inventory (BDI) [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
   Change in reported suicidal ideation
3. Daily activity/social interaction (Actigraph) [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
   Change in social interaction

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• English-speaking
• Seeking treatment for emotional distress and demonstration of elevated scores on standardized scales for depression and anxiety (i.e., Depression, Anxiety, and Stress Scale, anhedonia (i.e., PANAS-P)) and standardized scales for functional impairment (i.e., Sheehan Disability Scale)
• Willingness to refrain from other psychological treatments until study completion.
• Either stabilized on psychotropic medications (1 month for benzodiazepines and beta blockers, 3 months for SSRIs) or medication-free

Exclusion Criteria:

• Non-English speaking
• 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)
• Lifetime history of bipolar disorder, psychosis, mental retardation, or organic brain damage
• Active suicidal ideation
• Substance use disorder (including smoking) within the last six months. History of cocaine or stimulate use (e.g., amphetamine, cocaine, methamphetamine)
• Pregnancy
• Refusal of video/audio-taping therapy sessions

Contacts and Locations

Contacts

Contact: Shawn Wang, BA; (209) 800-8930; shawnwang@psych.ucla.edu

Contact: Michelle G Craske, PhD; 310-206-9191; MCraske@mednet.ucla.edu

Locations

United States, California

University of California, Los Angeles; Recruiting

Los Angeles, California, United States, 90095

Contact: Michelle G Craske, PhD 310-206-9191 MCraske@mednet.ucla.edu

Principal Investigator: Michelle G. Craske, Ph.D

United States, Texas

Southern Methodist University; Recruiting

Dallas, Texas, United States, 75205

Contact: Alicia E Meuret, PhD 214-768-3422 ameuret@mail.smu.edu

Principal Investigator: Alicia E Meuret, PhD

Principal Investigator: Thomas Ritz, PhD

Sponsors and Collaborators

University of California, Los Angeles

Southern Methodist University

More Information

• Responsible Party: Michelle Craske, Principal Investigator, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03439748
• Other Study ID Numbers: R61MH115138 ( U.S. NIH Grant/Contract )
• First Posted: February 20, 2018
• Last Update Posted: November 26, 2021
• Last Verified: November 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anhedonia; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases