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Behavioral Intervention

Mindfulness-Based Cognitive Therapy for Post-Traumatic Stress Disorder

N/A
Waitlist Available
Led By Anthony King, Ph.D
Research Sponsored by University of Michigan
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 (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.
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 study the effects of two types of therapy on patients with PTSD, by looking at changes in brain activity and connectivity.

Eligible Conditions
  • Post Traumatic Stress Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been through a traumatic experience that has caused symptoms such as flashbacks, avoiding reminders, negative thoughts and feelings, and feeling on edge. The trauma could be from violence like combat, physical assault, 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 two large-scale distributed functional connectivity networks: the Default Mode Network (DMN) and the Central Executive Network (CEN)
Secondary outcome measures
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.

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 MichiganLead Sponsor
1,782 Previous Clinical Trials
6,364,657 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,774 Previous Clinical Trials
2,674,303 Total Patients Enrolled
Ohio State UniversityLead Sponsor
821 Previous Clinical Trials
501,135 Total Patients Enrolled

Media Library

Mindfulness-Based Cognitive Therapy (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03874845 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Mindfulness-Based Cognitive Therapy, Muscle Relaxation Therapy (MRG)
Post-Traumatic Stress Disorder Clinical Trial 2023: Mindfulness-Based Cognitive Therapy Highlights & Side Effects. Trial Name: NCT03874845 — N/A
Mindfulness-Based Cognitive Therapy (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03874845 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT03874845 — N/A

Frequently Asked Questions

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

Is there an age-limit for recruiting participants in this research experiment?

"To be eligible for this medical study, individuals must between 18 and 72 years old. There are 46 different trials available to minors while 328 studies target seniors over 65 years of age."

Answered by AI

Is enrollment still open for the current trial?

"According to data available on clinicaltrials.gov, this study is presently searching for participants and has been since it was initially posted on January 29th 2022 with no updated information since then."

Answered by AI

Who would be the ideal candidates for this trial?

"Eligible applicants must be between 18 and 72 years old, have suffered moral injury, and meet other criteria. The recruitment process is seeking a total of 60 participants."

Answered by AI

How many individuals are actively taking part in this medical experiment?

"Confirmed. According to information available on clinicaltrials.gov, active recruitment for this medical trial is underway as of 1/29/2022. Sixty patients are needed from one particular site in order to complete the study."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
The Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I believe mindfulness can help save lives and I would like to be representation of it working.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
~0 spots leftby Mar 2025