Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_single Site
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Ohio State University
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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.
Detailed Description
Note: due to COVID precautions, treatment shifted from in-person to remote ("Zoom" videoconferencing)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 18 Years to 72 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Muscle Relaxation Therapy (Behavioral)
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.
Intervention: Mindfulness-Based Cognitive Therapy (Behavioral)
Outcomes
Primary Outcomes
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 Outcomes
- 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))
Investigators
Anthony P King
Associate Professor of Psychiatry, Faculty Associate, Institute for Behavioral Medicine Research, Institute for Behavioral Medicine Research, Institute for Social Research
Ohio State University