Development of a Novel Transdiagnostic Intervention for Anhedonia - R33 Phase
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|ClinicalTrials.gov Identifier: NCT04036136|
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : July 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anhedonia||Behavioral: Behavioral Activation Behavioral: Mindfulness Treatment||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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
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): NCT04036136
|Contact: Jessica Kinard, PhDfirstname.lastname@example.org|
|Contact: Lisalynn Kelleyemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Gabriel S Dichter, PhD||UNC-Chapel Hill|