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

Primary Purpose

Post Traumatic Stress Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness-Based Cognitive Therapy

Muscle Relaxation Therapy

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Mindfulness-Based Cognitive Therapy, Muscle Relaxation, fMRI, Group Psychotherapy

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Ann Arbor Healthcare System
University of MichiganRecruiting
The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Cognitive Therapy

Muscle Relaxation Therapy (MRG)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and dorsolateral prefrontal cortex (dlPFC)

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.

Secondary Outcome Measures

Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and insular cortex (Ins)

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.

Full Information

NCT ID

NCT03874793

First Posted

March 12, 2019

Last Updated

August 6, 2022

Sponsor

University of Michigan

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT03874793

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 29, 2019 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will examine the effects of psychotherapy as treatment for PTSD, and specifically how brain activity and brain connectivity is affected by Mindfulness Based Cognitive Therapy (MBCT) and an active mind-body comparison comparison therapy.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Traumatic Stress Disorder

Keywords

Mindfulness-Based Cognitive Therapy, Muscle Relaxation, fMRI, Group Psychotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

InvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-Based Cognitive Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Muscle Relaxation Therapy (MRG)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-Based Cognitive Therapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Muscle Relaxation Therapy

Intervention Description

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 Measure Information:

Title

Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and dorsolateral prefrontal cortex (dlPFC)

Description

Time Frame

pre-therapy and post therapy (approximately 8 weeks)

Secondary Outcome Measure Information:

Title

Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and insular cortex (Ins)

Description

Time Frame

pre-therapy and post therapy (approximately 8 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility 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) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jung Woon Park, BA

Phone

734-615-5249

jungp@med.umich.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony King, Ph.D.

Phone

734-936-4955

samadhi@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony King, Ph.D.

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Fresco, Ph.D

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Ann Arbor Healthcare System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105

Country

United States

Individual Site Status

Suspended

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jung Woon Park, BA

Phone

734-615-5249

jungp@med.umich.edu

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anthony P King, PhD

Phone

614-688-9537

anthony.king@osumc.edu

First Name & Middle Initial & Last Name & Degree

Alexis Berry, BS

Phone

614-688-9537

alexis.berry@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Within 36 months of completion of the project.

IPD Sharing 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.

Learn more about this trial

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

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