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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy
* Behavioral: Muscle Relaxation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Cognitive Therapy<br>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<br>* 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.<br>|
| Active Comparator: Muscle Relaxation Therapy (MRG)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | pre-therapy and post therapy (approximately 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | pre-therapy and post therapy (approximately 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-Based Cognitive Therapy, Muscle Relaxation, fMRI, Group Psychotherapy