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Behavioral Intervention

Mindfulness-Based Cognitive Therapy vs. Muscle Relaxation for PTSD

N/A
Waitlist Available
Led By Anthony King, Ph.D.
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-therapy and post therapy (approximately 8 weeks)
Awards & highlights

Study Summary

This trial will compare the effects of two types of therapy - MBCT and an active mind-body comparison therapy - on brain activity and connectivity in people with PTSD.

Who is the study for?
This trial is for individuals with PTSD or subsyndromal PTSD from interpersonal violence, combat, or sexual assault. Participants must meet DSM-5 criteria and have significant impairment but cannot join if they have dissociative PTSD, MRI contraindications like metal implants, current substance dependence, suicide risk, serious medical conditions like stroke or seizures, psychosis, schizophrenia history, bipolar disorder history or other factors that make participation unsafe.Check my eligibility
What is being tested?
The study is testing the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) compared to an active mind-body therapy in treating PTSD. It will look at changes in brain activity and connectivity as a result of these therapies to understand how they may alleviate symptoms of trauma.See study design
What are the potential side effects?
While not explicitly stated for this psychotherapy trial, potential side effects could include emotional discomfort due to recalling traumatic events during sessions and possible increased anxiety or stress levels as participants work through their experiences.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PTSD or symptoms of it due to violence, combat, or sexual assault.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-therapy and post therapy (approximately 8 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-therapy and post therapy (approximately 8 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and dorsolateral prefrontal cortex (dlPFC)
Secondary outcome measures
Group differences in the change in resting-state functional connectivity between posterior cingulate cortex (PCC) and insular cortex (Ins)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Cognitive TherapyExperimental Treatment1 Intervention
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.
Group II: Muscle Relaxation Therapy (MRG)Active Control1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Cognitive Therapy
2013
Completed Phase 2
~5470

Find a Location

Who is running the clinical trial?

University of MichiganOTHER
1,794 Previous Clinical Trials
6,373,827 Total Patients Enrolled
Ohio State UniversityLead Sponsor
827 Previous Clinical Trials
502,662 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
831 Previous Clinical Trials
668,844 Total Patients Enrolled

Media Library

Mindfulness-Based Cognitive Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03874793 — N/A
Mindfulness-Based Cognitive Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03874793 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT03874793 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the enrollment window for this clinical trial closed?

"Yes, the data uploaded on clinicaltrials.gov states that this experiment is presently recruiting participants. It was initially published on July 29th 2019 and last edited on August 6th 2022; they currently need 60 patients at 2 different medical sites."

Answered by AI

Is it possible to partake in the research protocol?

"To take part in this study, individuals must possess stress disorders related to trauma and be between 18 and 72 years of age. The total number of enrollees is 60 people."

Answered by AI

What is the magnitude of participation in this research endeavor?

"Affirmative. Clinicaltrials.gov records that this clinical study is actively recruiting patients, with the initial post on July 29th 2019 and recent changes made on August 6th 2022. The trial seeks to enrol 60 individuals across two medical sites."

Answered by AI

Are geriatric patients admissible for this research study?

"As stated in the trial's prerequisites, only individuals between 18 and 72 years old qualify. Moreover, there are 46 studies designed to help minors and 328 for elderly participants."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Michigan
How old are they?
18 - 65
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I've tried numerous attempts.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)
Anthony P King 2019. "Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03874793.
~16 spots leftby Apr 2025
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