Status:
COMPLETED
Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Duke University
National Institute of Mental Health (NIMH)
Conditions:
Anhedonia
Eligibility:
All Genders
18-50 years
Phase:
NA
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 neuroimag...
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, schizophreni...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04036136
Start Date
August 1 2019
End Date
July 31 2023
Last Update
June 21 2024
Active Locations (1)
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1
UNC-Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States, 27599-7255