- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03874793
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active comparison therapy called Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will be randomly assigned to receive 8 weeks of group therapy in either MBCT or MRT treatments. Prior to receiving therapy participants will: complete baseline assessments related to their PTSD; fill out surveys; have an functional magnetic resonance imaging (fMRI); and provide saliva samples. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.
Due to COVID precautions, treatments shifted from in-person to remotely-delivered ("Zoom" video-conferencing) modality.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jung Woon Park, BA
- Phone Number: 734-615-5249
- Email: jungp@med.umich.edu
Study Contact Backup
- Name: Anthony King, Ph.D.
- Phone Number: 734-936-4955
- Email: samadhi@med.umich.edu
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Meets current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for PTSD (with or without Major Depressive Disorder) or subsyndromal PTSD (has qualifying trauma, has intrusive and avoidant symptoms, and at least one negativity and one arousal symptom, and significant impairment); type of trauma shall be interpersonal violence, combat, and/or sexual assault, etc.
Exclusion Criteria:
- Dissociative PTSD
- Delayed-onset PTSD
- Magnetic Resonance Imaging (MRI) contraindications (e.g. metal in body, inability to be in the scanner - claustrophobia, severe back pain, etc.)
- Serious medical or neurologic conditions (e.g. stroke, seizures)
- Suicide risk
- Psychosis
- Life history of schizophrenia
- Life history of bipolar disorder
- Current substance dependence
- Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-Based Cognitive Therapy
Participants will have 8 weeks of group therapy and will be asked to do MBCT exercises for approximately 20-30 minutes on 5 or more days/week.
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Participants will attend 8 weekly group therapy sessions.
Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
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Active Comparator: Muscle Relaxation Therapy (MRG)
Participants will have 8 weeks of group therapy participants and will be asked to do MRG exercises for approximately 20-30 minutes on 5 or more days/week.
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Participants will attend 8 weekly group therapy sessions.
Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and dorsolateral prefrontal cortex (dlPFC)
Time Frame: pre-therapy and post therapy (approximately 8 weeks)
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Network functional connectivity will be measured through fMRI blood oxygen level dependent [BOLD] signal.
Time-course of BOLD signal while participants are "resting" / not performing a task will be used identify brain regions whose activity time-course is correlated with a brain region of interest (ROI), called a "seed" ROI.
We will use activity in the PCC as a seed ROI and search for regions of time-course correlation within the dlPFC, searching for dlPFC clusters within an anatomical mask of middle frontal cortex.
Betas for identified dlPFC clusters will be extracted.
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pre-therapy and post therapy (approximately 8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and insular cortex (Ins)
Time Frame: pre-therapy and post therapy (approximately 8 weeks)
|
Network functional connectivity will be measured through fMRI BOLD signal.
Time-course of BOLD signal while participants are "resting" / not performing a task will be used identify brain regions whose activity time-course is correlated with a PCC seed ROI and search for regions of time-course correlation within the insula cortex, searching for clusters within an anatomical mask of insular cortex.
Betas for identified insula clusters will be extracted.
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pre-therapy and post therapy (approximately 8 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Fresco, Ph.D, University of Michigan
- Principal Investigator: Anthony King, Ph.D., Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00152509
- 1R61AT009867-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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