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Trial record 1 of 35 for:    Anhedonia
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Development of a Novel Transdiagnostic Intervention for Anhedonia

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ClinicalTrials.gov Identifier: NCT02874534
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

August 17, 2016
August 22, 2016
September 14, 2017
June 22, 2017
November 2021   (Final data collection date for primary outcome measure)
Change from Baseline to Week 15 in Neural Activation [ Time Frame: Baseline, 15 weeks ]
Neural activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task
Same as current
Complete list of historical versions of study NCT02874534 on ClinicalTrials.gov Archive Site
Change from Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score [ Time Frame: Baseline, 15 weeks ]
The Snaith-Hamilton Pleasure Scale (SHAPS), a well-validated 14-item questionnaire will be used to assess hedonic capacity. The sum of the 14 items scores ranges from 0 to 56. A higher score represents more anhedonic symptoms.
Same as current
Not Provided
Not Provided
 
Development of a Novel Transdiagnostic Intervention for Anhedonia
Development of a Novel Transdiagnostic Intervention for Anhedonia
The overall goal of this project is to develop a novel transdiagnostic treatment for anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA), using ultra-high field functional neuroimaging. There is a critical need for a validated treatment that specifically targets anhedonia, and this project will evaluate the effects of this new treatment on anhedonia and will establish how this treatment impacts brain systems that mediate reward processing, clinical symptoms of anhedonia, functional outcomes, and behavioral indices of reward processing. This work will also identify brain targets by which future novel anhedonia treatment may be evaluated.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Anhedonia
  • Behavioral: Behavioral Activation
    Treatment will consist of 15 weekly 45-minute sessions.
  • Behavioral: Mindfulness Treatment
    Treatment will consist of 15 weekly 45-minute sessions.
  • Experimental: Behavioral Activation
    Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment.
    Intervention: Behavioral: Behavioral Activation
  • Active Comparator: Mindfulness Treatment
    BATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions.
    Intervention: Behavioral: Mindfulness Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
Same as current
November 2021
November 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18-50 years old and treatment seeking;
  2. SHAPS scores ≥ 20, corresponding to clinically significant anhedonia;
  3. Clinician's Global Impression Scale-Severity score (CGI-S) > 3 to assure a clinically impaired sample;
  4. Seeking treatment for anhedonia (i.e., referred from an outpatient clinic or responded to an advertisement for anhedonia treatment; endorses desire for treatment during screening).

Exclusion Criteria:

  1. Those for whom medication management is the primary gold-standard treatment, including those with bipolar disorder/mania, schizophrenia spectrum, and other psychotic disorders;
  2. Prior treatment with behavioral activation therapy for depression or mindfulness-based treatments (those with exposure to other forms of psychotherapy, e.g., supportive therapy, will be eligible);
  3. Those who may have difficulty understanding the cognitive components of BATA, including those with intellectual disability, neurocognitive disorders, and dissociative disorders;
  4. Feeding and eating disorders which may have confounding effects on the fMRI signal;
  5. Substance Use Disorders given confounding effects of substances of abuse on the fMRI signal;
  6. Suicidal intent and plan;
  7. Psychotropic medication use in the past 4 weeks (8 weeks for fluoxetine) and/or current psychotherapy. Participants must be medication-free at study entry; study personnel will not supervise medication taper for the purpose of the study, but those who taper under the supervision of their regular provider will be eligible;
  8. Currently pregnant, as measured by urine pregnancy screen immediately before MRI scans;
  9. Positive urinalysis screen for cocaine, marijuana, opiates, methadone, amphetamines, and benzodiazepines (conducted on-site via Biosite Triage Meter Plus) at study entry.
  10. No neurological conditions (e.g., history of stroke, seizure, or TBI);
  11. Contraindications for fMRI imaging: Metal in the body, dental work that is not fillings or gold, any tattoos, any metal in the body, any metal injury - especially those to the eyes, any other type of implant unless they are 100% plastic.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact: Marcy E McLamb 919-966-3594 Marcy.Mclamb@cidd.unc.edu
Contact: Lisalynn Kelley lisalynn.kelley@duke.edu
United States
 
 
NCT02874534
16-2268
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Duke University
Principal Investigator: Gabriel S Dichter, PhD UNC-Chapel Hill
University of North Carolina, Chapel Hill
September 2017

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