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

The Ohio State University

Status: Withdrawn

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: Muscle Relaxation Therapy; Behavioral: Mindfulness-Based Cognitive Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03874845

HUM00152509.K23

K23MH112852 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 72 years old

Volunteers: No 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 (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy

Experimental group

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.

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy

Muscle Relaxation Therapy (MRG)

Active Comparator group

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.

Treatment:

Behavioral: Muscle Relaxation Therapy