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| ID | Type | Description | Link |
|---|---|---|---|
| R61MH110027 | 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 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).
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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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | Treatment will consist of 15 weekly 45-minute sessions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Snaith-Hamilton Pleasure Scale Score Over Time | 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. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 15 weeks. | Baseline, Post-treatment (between 8 to 15 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neural Activation During MID Task Anticipation Phase | Neural activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. MID task reward anticipation is defined by the contrast in fMRI signal between reward and neutral trials during the presentation of cues and the fixation cross. Because this subtraction method is used to define the fMRI signal, it is possible for this value to be negative. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 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 School of Medicine | Chapel Hill | North Carolina | 27599-7255 | 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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Will share de-identified data through the National Database for Clinical Trials Related to Mental Illness (NDCT)
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Activation | Treatment will consist of 8-15 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 8-15 weekly 45-minute sessions. |
| FG001 | Mindfulness Treatment | Behavioral Activation Therapy 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. Treatment will be compromised of 8-15 weekly 45-minute sessions. Mindfulness Treatment: Treatment will consist of 8-15 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 8-15 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 8-15 weekly 45-minute sessions. |
| Units | Counts |
|---|---|
| Participants |
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| 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 in Snaith-Hamilton Pleasure Scale Score Over Time | 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. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 15 weeks. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-treatment (between 8 to 15 weeks) |
|
Adverse event data were collected from the time of signing informed consent through final MRI sessions. Due to the design of the trial, each participant was in the trial for between 8-15 weeks.
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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 8-15 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 8-15 weekly 45-minute sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Dichter, PhD | University of North Carollina at Chapel Hill | 919-364-4275 | 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 9, 2023 | Mar 26, 2024 | 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. |
|
| Baseline, Post-treatment (between 8 to 15 weeks) |
| Change in Neural Activation During MID Task Outcome Phase | Brain activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. MID task reward outcome is defined by the contrast in fMRI signal between successful and unsuccessful reward trials during the presentation of feedback. Because this subtraction method is used to define the fMRI signal, it is possible for this value to be negative. | up to 15 weeks |
| 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. |
| 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 8-15 weekly 45-minute sessions. Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 8-15 weekly 45-minute sessions. Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions. |
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| Secondary | Change in Neural Activation During MID Task Anticipation Phase | Neural activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. MID task reward anticipation is defined by the contrast in fMRI signal between reward and neutral trials during the presentation of cues and the fixation cross. Because this subtraction method is used to define the fMRI signal, it is possible for this value to be negative. Treatment duration varied across participants. Participants participated in as few as 8 weekly sessions or in as many as 15 weekly sessions of psychotherapy, based on therapist judgement. Thus the outcome measure timeframe varied between 8 and 15 weeks. | Posted | Mean | Standard Deviation | percent signal change | Baseline, Post-treatment (between 8 to 15 weeks) |
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| Secondary | Change in Neural Activation During MID Task Outcome Phase | Brain activation assessed by Functional Magnetic Resonance Imaging (fMRI) during Monetary Incentive Delay (MID) task. During MID the task, participants respond to "win" trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. MID task reward outcome is defined by the contrast in fMRI signal between successful and unsuccessful reward trials during the presentation of feedback. Because this subtraction method is used to define the fMRI signal, it is possible for this value to be negative. | Posted | Mean | Standard Deviation | percent signal change | up to 15 weeks |
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| 0 |
| 61 |
| 0 |
| 61 |
| 4 |
| 61 |
| 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 8-15 weekly 45-minute sessions. Mindfulness Treatment: Treatment will consist of 8-15 weekly 45-minute sessions. | 0 | 55 | 0 | 55 | 11 | 55 |
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D013568 | Pathological Conditions, Signs and Symptoms |