Clinical trial NCT03874793: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
Official title: Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
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 Center for Complementary and Integrative Health (NCCIH)
name: University of Michigan
First posted: 2019-03-14
Enrollment: 89
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, 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.

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 (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

Primary outcomes:
measure: Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and dorsolateral prefrontal cortex (dlPFC)
timeFrame: pre-therapy and post therapy (approximately 8 weeks)
Secondary outcomes:
measure: Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and insular cortex (Ins)
timeFrame: pre-therapy and post therapy (approximately 8 weeks)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Anthony King, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: David Fresco, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: