Clinical trial NCT03874845: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_VA Only
Official title: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)_single Site
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Mindfulness-Based Cognitive Therapy
Muscle Relaxation
fMRI
Group Psychotherapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: pre-therapy and post therapy (approximately 8 weeks)
Secondary outcomes:
measure: 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.
timeFrame: pre-therapy and post therapy (approximately 8 weeks)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: University of Michigan and The Ohio State University
name: Anthony King, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: