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Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04036136
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 30, 2020
Duke University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anhedonia Behavioral: Behavioral Activation Behavioral: Mindfulness Treatment Not Applicable

Detailed Description:

Deficits in motivation and pleasure, together referred to as anhedonia, are implicated in a number of psychiatric illnesses, including mood and anxiety disorders, substance-use disorders, schizophrenia, and attention-deficit/hyperactivity disorder. As a result, constructs related to anhedonia are central to the NIMH Research Domain Criteria (RDoC) project. Anhedonia is often one of the most difficult psychiatric symptoms to treat and thus represents a critical endophenotype and vulnerability factor for a range of psychiatric disorders. Given the centrality of anhedonia to a large number of psychiatric disorders, improved interventions to treat motivation and pleasure are critical for these disorders. The overall goal of this R61/R33 project is to develop a novel transdiagnostic treatment for anhedonia, called Behavioral Activation Treatment for Anhedonia (BATA). This new intervention is designed to treat anhedonia by emphasizing supported engagement with personally relevant goals and reducing avoidance behaviors. Consistent with the objectives and milestones outlined in RFA-MH-16-406 ("Exploratory Clinical Trials of Novel Interventions for Mental Disorders"), in the R61 phase of this trial that lasted from June 22, 2017-July 31, 2019, the investigators proposed to use an experimental therapeutics approach to first evaluate mesocorticolimbic target engagement by this treatment in a transdiagnostic sample characterized by clinically impairing anhedonia (Aim 1). Specifically, the investigators examined the effects of this treatment, relative to an active comparison treatment, on caudate nucleus activation during reward anticipation and rostral anterior cingulate cortex activation during reward outcomes using ultra-high field (7T) functional magnetic resonance imaging. The investigators also used fMRI to determine the optimal dose of the intervention (Aim 2).

In the current R33 phase of the study, which begins recruitment 8/1/2019, the investigators plan to evaluate the effects of the optimal dose of this new treatment, versus an active comparison treatment, on anhedonic symptoms and functional outcomes (Aim 3), behavioral indicators of reward sensitivity (Aim 4), and neural indicators of reward processing (Aim 5).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
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.
Behavioral: Behavioral Activation
Treatment will consist of 15 weekly 45-minute sessions.

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.
Behavioral: Mindfulness Treatment
Treatment will consist of 15 weekly 45-minute sessions.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-50 years old and treatment seeking;
  • SHAPS scores ≥ 20, corresponding to clinically significant anhedonia;
  • Clinician's Global Impression Scale-Severity score (CGI-S) > 3 to assure a clinically impaired sample;
  • 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:

  • Those for whom medication management is the primary gold-standard treatment, including those with bipolar disorder/mania, schizophrenia spectrum, and other psychotic disorders;
  • 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);
  • Those who may have difficulty understanding the cognitive components of BATA, including those with intellectual disability, neurocognitive disorders, and dissociative disorders;
  • Feeding and eating disorders which may have confounding effects on the fMRI signal;
  • Substance Use Disorders given confounding effects of substances of abuse on the fMRI signal;
  • Suicidal intent and plan;
  • 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;
  • Currently pregnant, as measured by urine pregnancy screen immediately before MRI scans;
  • Positive urinalysis screen for cocaine, marijuana, opiates, methadone, amphetamines, and benzodiazepines (conducted on-site via Biosite Triage Meter Plus) at study entry.
  • No neurological conditions (e.g., history of stroke, seizure, or TBI); 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.

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 identifier (NCT number): NCT04036136

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Contact: Jessica Kinard, PhD 919-966-3594
Contact: Lisalynn Kelley

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United States, North Carolina
UNC-Chapel Hill School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599-7255
Contact: Gabriel S Dichter, PhD    919-445-0132   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
National Institute of Mental Health (NIMH)
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Principal Investigator: Gabriel S Dichter, PhD UNC-Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT04036136    
Other Study ID Numbers: 16-2268b
R61MH110027 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will share de-identified data through the National Database for Clinical Trials Related to Mental Illness (NDCT)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases