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Trial record 8 of 34 for:    Anhedonia

Treatment for Affect Dimensions (TAD)

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ClinicalTrials.gov Identifier: NCT03439748
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Southern Methodist University
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles

February 5, 2018
February 20, 2018
July 12, 2018
September 1, 2018
August 30, 2020   (Final data collection date for primary outcome measure)
  • Positive and Negative Affect Scale (PANAS) and interviewer-rated anhedonia [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
    Change in reported positive and negative affect
  • Depression Anxiety and Stress Scale (DASS) [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
    Change in reported symptoms of anxiety and stress
  • Positive and Negative Affect Scale (PANAS) [ Time Frame: Change from baseline to post-treatment (15 weeks) and follow-up (6 months post-treatment) ]
    Change in reported positive and negative affect
  • Depression Anxiety and Stress Scale (DASS) [ Time Frame: Change from baseline to post-treatment (15 weeks) and follow-up (6 months post-treatment) ]
    Change in reported symptoms of anxiety and stress
Complete list of historical versions of study NCT03439748 on ClinicalTrials.gov Archive Site
Suicide ideation [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
Change in reported suicidal ideation, ex. Sheehan Disability Scale
Suicide ideation [ Time Frame: Change from baseline to post-treatment (15 weeks) and follow-up (6 months post-treatment) ]
Change in reported suicidal ideation
Not Provided
Not Provided
 
Treatment for Affect Dimensions
Reward Sensitivity as a Mechanism of Positive Affect Treatment of Anhedonia

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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anhedonia
  • Depression
  • Anxiety
  • 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.
  • 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
  • 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
    Intervention: Behavioral: Positive Affect Treatment
  • 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
    Intervention: Behavioral: Negative Affect Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
August 30, 2020
August 30, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)
  • either stabilized on psychotropic medications (1 month for benzodiazepines and beta blockers) or medication-free
  • English-speaking

Exclusion Criteria:

  • patient report of serious medical conditions - such as respiratory (e.g., chronic obstructive pulmonary disease), cardiovascular, pulmonary, neurological, muscular-skeletal diseases, uncontrolled hyper- or hypothyroidism, uncontrolled high blood pressure, and history of seizures or epilepsy)
  • intellectual disability or organic brain damage
  • history of bipolar I or II disorder, schizophrenia-spectrum disorder, or suicide attempt
  • active suicidal ideation or self-harm within the past year
  • substance use disorder within the last six months
  • pregnancy
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Michelle G Craske, PhD 310-206-9191 craske@psych.ucla.edu
United States
 
 
NCT03439748
R61MH110048
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Michelle Craske, University of California, Los Angeles
University of California, Los Angeles
Southern Methodist University
Not Provided
University of California, Los Angeles
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP