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

The Ohio State University

Status: Completed

Conditions: Post Traumatic Stress Disorder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03874793

HUM00152509

1R61AT009867-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

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 (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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 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