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

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Behavioral: Muscle Relaxation Therapy; Behavioral: Mindfulness-Based Cognitive Therapy

• Registration Number: NCT03874793
• Lead Sponsor: Ohio State University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-12
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Study Start: 2019-07-29
• Primary Completion: 2023-12-01
• Status Verified: 2024-03
• Study Completion: 2024-03-01
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Muscle Relaxation Therapy (MRG)	Muscle Relaxation Therapy	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.
Mindfulness-Based Cognitive Therapy	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.

Primary Outcome Measures

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

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

Trial Locations

Locations (2)

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States