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Trial record 9 of 35 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 : October 11, 2018
Sponsor:
Collaborator:
Southern Methodist University
Information provided by (Responsible Party):
Michelle Craske, University of California, Los Angeles

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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

  2. Depression Anxiety and Stress Scale (DASS) [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
    Change in reported symptoms of anxiety and stress


Secondary Outcome Measures :
  1. Suicide ideation [ Time Frame: Change from baseline to post-treatment (15 weeks) ]
    Change in reported suicidal ideation, ex. Sheehan Disability Scale



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439748


Contacts
Contact: Michelle G Craske, PhD 310-206-9191 craske@psych.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    craske@psych.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

Responsible Party: Michelle Craske, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03439748     History of Changes
Other Study ID Numbers: R61MH110048
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

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
Signs and Symptoms