CompletedNot Applicable

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

United States61 participantsStarted 2019-07-29

Plain-language 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.

Who can participate

Age range

18 Years – 72 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change (From Intake to Post-therapy) in Resting-state Functional Connectivity Between Posterior Cingulate Cortex (PCC) and Dorsolateral Prefrontal Cortex (dlPFC)

Timeframe: Intake (pre-therapy) and post therapy (approximately 9 - 10 weeks)

Trial details

NCT IDNCT03874793

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Results submitted2025-03-15

View on ClinicalTrials.gov More Post Traumatic Stress Disorder trials

Who can participate

Age range

18 Years – 72 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.