N/A
N=57
Development of a Novel Transdiagnostic Intervention for Anhedonia - R61 Phase
Anhedonia
Bottom Line
View on ClinicalTrials.gov: NCT02874534 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline to Week 15 in Neural Activation — 0.0075; -0.1059 Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Activation (Behavioral); Mindfulness Treatment (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 15 in Neural Activation |
0.0075; -0.1059 | — |
| SECONDARY Change From Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score |
8.0; 9.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02874534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.