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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH110027-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | Treatment will consist of 15 weekly 45-minute sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score | 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. | Baseline, 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel S Dichter, PhD | UNC-Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39213738 | Derived | 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. | |
| 38815760 | Derived |
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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.
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Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Activation: Treatment will consist of 15 weekly 45-minute sessions. |
| FG001 | Mindfulness Treatment | Behavioral Activation Treatment for Anhedonia (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. Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Activation: Treatment will consist of 15 weekly 45-minute sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The fMRI data quality for one participant was inadequate and was excluded from the analysis. | Posted | Mean | Standard Deviation | Z-score | Baseline, 15 weeks |
|
From initial assessment through post treatment scan, a total of approximately 3 to 5 months.
Study team members (e.g., study coordinator, study therapists) asked participants at each visit following the initial appointment if any adverse events or changes in health were experienced since the last visit. Adverse Events were assessed by a trained study coordinator, study therapist, or other approved study team member, and discussed at the weekly research staff meetings.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Activation: Treatment will consist of 15 weekly 45-minute sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriel S. Dichter, PhD | University of North Carolina at Chapel Hill | 9194450132 | dichter@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2019 | Feb 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| Mindfulness Treatment | Behavioral | Treatment will consist of 15 weekly 45-minute sessions. |
|
| 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. |
| 37148652 | 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. |
| 36907457 | 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. |
| Ongoing in study |
|
| BG001 | 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. Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| SHAPS | The Snaith-Hamilton Pleasure Scale (SHAPS) is a 14-item self-report scale that measures the ability to experience pleasure. The SHAPS scale has a range from 14-56. Higher scores on the SHAPS scale indicate less ability to experience pleasure. | Mean | Standard Deviation | units on a scale |
|
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 Activation: Treatment will consist of 15 weekly 45-minute sessions. |
| OG001 | 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. Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions. |
|
|
| Secondary | Change From Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score | 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. | The fMRI data quality for one participant was inadequate and was excluded from the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 15 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 10 |
| 31 |
| EG001 | 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. Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions. | 0 | 26 | 0 | 26 | 12 | 26 |
| Burns on right forearm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cold Symptoms | Infections and infestations | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Elevated TSH | Endocrine disorders | Systematic Assessment |
|
| Flu | Infections and infestations | Systematic Assessment |
|
| Hip Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Intermittent eye twitching | Eye disorders | Systematic Assessment | Intermittent eye twitching after mri scan |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Scalp Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment | Suicidal Ideation secondary to motor vehicle accident |
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| Telogen Effluvium | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Presyncopal Episode | Cardiac disorders | Systematic Assessment |
|
| Broken Collar Bone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Streptococcal pharyngitis | Infections and infestations | Systematic Assessment |
|
| Worsening arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | worsening arthritis pain (back & neck) secondary to MRI |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |