Development of a Novel Transdiagnostic Intervention for Anhedonia - R61 Phase

NCT02874534 | Completed Results DMC

• 2 other identifiers: 16-2268aR61MH110027-01A1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Anhedonia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 15 in Neural Activation

  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.

  Baseline, 15 weeks

Secondary Outcomes (1)

• Change From Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score

  Baseline, 15 weeks

Study Arms (2)

Behavioral Activation

EXPERIMENTAL

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

Mindfulness Treatment

ACTIVE COMPARATOR

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

Interventions

Behavioral Activation BEHAVIORAL

Treatment will consist of 15 weekly 45-minute sessions.

Behavioral Activation

Mindfulness Treatment BEHAVIORAL

Treatment will consist of 15 weekly 45-minute sessions.

Mindfulness Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Duke University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (4)

• Cernasov PM, Walsh EC, Nagy GA, Kinard JL, Kelley L, Phillips RD, Pisoni A, Diehl J, Haworth K, West J, Freeman L, Pfister C, Scott M, Daughters SB, Gaylord S, Dichter GS, Smoski MJ. A parallel-arm, randomized trial of Behavioral Activation Therapy for anhedonia versus mindfulness-based cognitive therapy for adults with anhedonia. Behav Res Ther. 2024 Nov;182:104620. doi: 10.1016/j.brat.2024.104620. Epub 2024 Aug 23.

  PMID: 39213738 DERIVED

• Gibson K, Cernasov P, Styner M, Walsh EC, Kinard JL, Kelley L, Bizzell J, Phillips R, Pfister C, Scott M, Freeman L, Pisoni A, Nagy GA, Oliver JA, Smoski MJ, Dichter GS. The effects of psychotherapy for anhedonia on subcortical brain volumes measured with ultra-high field MRI. J Affect Disord. 2024 Sep 15;361:128-138. doi: 10.1016/j.jad.2024.05.140. Epub 2024 May 28.

  PMID: 38815760 DERIVED

• Cernasov PM, Kinard JL, Walsh E, Kelley L, Phillips R, Pisoni A, Arnold M, Lowery SC, Ammirato M, Nagy GA, Oliver JA, Haworth K, Daughters SB, Dichter GS, Smoski M. Parsing within & between-person dynamics of therapy homework completion and clinical symptoms in two cognitive behavioral treatments for adults with anhedonia. Behav Res Ther. 2023 Jul;166:104322. doi: 10.1016/j.brat.2023.104322. Epub 2023 Apr 26.

  PMID: 37148652 DERIVED

• Phillips R, Walsh E, Jensen T, Nagy G, Kinard J, Cernasov P, Smoski M, Dichter G. Longitudinal associations between perceived stress and anhedonia during psychotherapy. J Affect Disord. 2023 Jun 1;330:206-213. doi: 10.1016/j.jad.2023.03.011. Epub 2023 Mar 11.

  PMID: 36907457 DERIVED

MeSH Terms

Conditions

Anhedonia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

These results represent the complete therapeutic target results for this trial's R61 phase that may be combined with the results of the ongoing clinical endpoint R33 phase study whose final results will be reported in NCT04036136.

Results Point of Contact

• Title: Gabriel S. Dichter, PhD
• Organization: University of North Carolina at Chapel Hill

dichter@med.unc.edu

9194450132

Study Officials

• Gabriel S Dichter, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: June 22, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: April 24, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)