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

• Sponsor: University of Michigan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03874845
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Ohio State University (Other)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 28.1
• Patients Per Site: 30
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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	N/A

Detailed Description

Note: due to COVID precautions, treatment shifted from in-person to remote ("Zoom" videoconferencing)

Study Design

• Study Type: Interventional
• Anticipated 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.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
• Actual Study Start Date: Jan 29, 2022
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

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) [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 72 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (qualifying trauma, and at least one intrusive, one avoidant, one negativity, and one arousal symptoms, and significant impairment or distress); type of trauma shall include interpersonal violence - combat, physical assault, 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 severe substance use disorder

• Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System	Ann Arbor	Michigan	United States	48105
2	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• University of Michigan
• National Institute of Mental Health (NIMH)
• Ohio State University

Investigators

• Principal Investigator: Anthony King, Ph.D, University of Michigan and The Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anthony King, Adj Asst and Associate Professor of Psychiatry, Faculty Associate, Institute for Behavioral Medicine Research, Institute for Behavioral Medicine Research, Institute for Social Research, University of Michigan
• ClinicalTrials.gov Identifier: NCT03874845
• Other Study ID Numbers: HUM00152509.K23; K23MH112852
• First Posted: Mar 14, 2019
• Last Update Posted: Feb 14, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anthony King, Adj Asst and Associate Professor of Psychiatry, Faculty Associate, Institute for Behavioral Medicine Research, Institute for Behavioral Medicine Research, Institute for Social Research, University of Michigan: Mindfulness-Based Cognitive Therapy; Muscle Relaxation; fMRI; Group Psychotherapy
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Feb 14, 2022