Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Development of a Novel Transdiagnostic Intervention for Anhedonia - R61 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02874534
Recruitment Status : Completed
First Posted : August 22, 2016
Results First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
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 propose 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 will examine 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. In this phase of the project, the investigators will also use fMRI to determine the optimal dose of the intervention (Aim 2).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Novel Transdiagnostic Intervention for Anhedonia - R61 Phase
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

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 Neural Activation [ Time Frame: Baseline, 15 weeks ]
    Change due to BATA, relative to MBCT, from baseline in right caudate nucleus activation during the anticipation phase of the Monetary Incentive Delay (MID) task assessed by Functional Magnetic Resonance Imaging (fMRI). The BOLD (Blood Oxygen Level-Dependent signal change is expressed as a z-score that represents the magnitude of change relative to baseline. A score of 0 would correspond to no change, and a score of 1 would represent 1 standard deviation of change. The difference in z-scores between the BATA and the MBCT groups reflects the difference in change in fMRI responses between the two treated groups. Thus even a score of 0 in the BATA group may reflect greater change than observed in the MBCT group if change in the MBCT group is negative.


Secondary 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), used to assess hedonic capacity. The sum of the 14 items scores ranges from 0 to 56. A higher score represents more anhedonic symptoms. The below means represent change in units on the Snaith-Hamilton Pleasure Scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02874534


Locations
Layout table for location information
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Gabriel S Dichter, PhD UNC-Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02874534    
Other Study ID Numbers: 16-2268a
R61MH110027-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2016    Key Record Dates
Results First Posted: April 24, 2020
Last Update Posted: April 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared via the NIMH Data Archive (NDA), collection #2595. Investigators may access the deidentified IPD directly from NDA without needing to contact the study team directly.
Time Frame: Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
Access Criteria: To request access to data, you must be sponsored by an NIH-recognized institution with a Federalwide Assurance and have a research related need to access NDA data. See https://nda.nih.gov/get/access-data.html for more information.
URL: https://nda.nih.gov/edit_collection.html?id=2595

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anhedonia
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms