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Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_VA Only

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ClinicalTrials.gov Identifier: NCT03874845
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony King, University of Michigan

Brief Summary:
This study will examine the effects of psychotherapy as treatment for PTSD. This research will see how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy (MRT). Participants that qualify to be in this study will receive 8 weeks of group therapy in MBCT or MRT. 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 a saliva sample. These assessments will be repeated after the therapy is over. Overall study participation should last approximately 10-12 weeks.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Mindfulness-Based Cognitive Therapy Behavioral: Muscle Relaxation Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: treatment groups will consist of a minimum of 4 participants (preferably 5-8). The statistician will randomize the groups once a sufficient number of participants have enrolled to ensure desired group size.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Statistician will not know the group assignment until blind is broken. Statistician randomizes the groups. Principal investigator will not know group assignment until blind is broken.
Primary Purpose: Treatment
Official Title: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_single Site
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


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.
Behavioral: Mindfulness-Based Cognitive Therapy
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.

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.
Behavioral: Muscle Relaxation Therapy
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.




Primary Outcome Measures :
  1. Group differences in the change in resting-state functional connectivity between two large-scale distributed functional connectivity networks: the Default Mode Network (DMN) and the Central Executive Network (CEN) [ Time Frame: pre-therapy and post therapy (approximately 8 weeks) ]
    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 to identify patterns of functional connectivity between two large-scale neural networks DMN and CEN. We will use the Brain Basis Set methodology: creating a whole-brain correlation matrix between all combinations of hundreds of brain regions throughout the brain (a "connectome") followed by data-reduction methods (principle components analyses, PCA) to examine the structure of functional connectivity patterns between nodes of canonical intrinsic connectivity networks.


Secondary Outcome Measures :
  1. Group differences in the change in resting-state functional connectivity between two large-scale distributed functional connectivity networks: the Default Mode Network (DMN) and the Salience Network (SN), measured through fMRI BOLD signal. [ Time Frame: pre-therapy and post therapy (approximately 8 weeks) ]
    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 patterns of functional connectivity between two large-scale neural networks DMN and CEN using the Brain Basis Set methodology.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for PTSD (with or without Major Depressive Disorder); type of trauma is not restricted and can include interpersonal violence, combat, and 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

Information from the National Library of Medicine

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): NCT03874845


Contacts
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Contact: Elizabeth Hinckley, BA 734-764-9527 ehinckly@med.umich.edu
Contact: Anthony King, Ph.D 734-936-4955 samadhi@med.umich.edu

Locations
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United States, Michigan
VA Ann Arbor Healthcare System Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Elizabeth Hinckley, BA    734-764-9527    ehinckly@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Anthony King, Ph.D University of Michigan

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Responsible Party: Anthony King, Assistant Professor of Psychiatry, Medical School and Faculty Associate, Research Center for Group Dynamics, Institute for Social Research, University of Michigan
ClinicalTrials.gov Identifier: NCT03874845     History of Changes
Other Study ID Numbers: HUM00152509.K23
K23MH112852 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to make available data from fMRI scans from human subjects initially to collaborators for independent replication / data pooling. We also plan to make the de-identified brain scans available to the broad scientific community, however, additional redaction steps may need to be made to brain scans to ensure subject confidentiality / inability to identify individuals from brain scans. Completely de-identified research data (redacted according to NIH practice to prevent disclosure of personal identifiers) which documents the research findings will be made available after the main findings from the finalized research dataset have been accepted for publication. And with approval of Dept Veterans Affairs Office of Research and Development.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 36 months of completion of the project.
Access Criteria: Access to data generated by the project will be available for educational, research and non-profit purposes to researchers who provide a methodologically sound proposal. Data generated under this project will be administered in accordance with NIH Sharing policies, including NIH Policy on Dissemination of NIH-Funded Clinical Trial Information (8/2016), and the NIH Grants Policy Statement (Availability of Research Results) (11/2015). Depending on such NIH policies, Data generated by this project may be available for educational, research or non-commercial purposes under the terms of a data use agreement. Data will be stored in an established data repository (e.g. Inter-university Consortium for Political and Social Research (ICPSR): icpsr.umich.edu) with appropriate provisions for curation and longterm preservation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony King, University of Michigan:
Mindfulness-Based Cognitive Therapy
Muscle Relaxation
fMRI
Group Psychotherapy
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders