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Mind-Body Practice
Mindfulness-Based Cognitive Therapy 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights
Study Summary
This trial is for people who live in areas hard hit by COVID-19 and have a history of trauma. The trial will test two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy.
Who is the study for?
This trial is for people with a history of trauma who live in certain Michigan counties and are currently experiencing high levels of COVID-related stress. They must score above specific thresholds on the COVID stress scale and Penn State Worry Questionnaire to qualify. Those at risk of suicide, with PTSD, substance dependence, schizophrenia, psychosis or other conditions that make participation unsafe cannot join.Check my eligibility
What is being tested?
The study tests how Mindfulness-Based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy (MRT) affect individuals with trauma histories facing current COVID-related distress. Participants will receive one of these therapies remotely over 8 weeks, with assessments before and after treatment.See study design
What are the potential side effects?
While not explicitly stated for this therapy-focused trial, common side effects from MBCT or MRT may include temporary discomfort during practice, emotional upsets when processing difficult memories or feelings during mindfulness exercises.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PROMIS (adult short form) Emotional Depression survey
Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey
Penn State Worry Questionnaire (PSWQ-16) Worry survey
+1 moreSecondary outcome measures
Mental Depression
Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey group differences (MBCT and PMR)
Penn State Worry Questionnaire (PSWQ-16) Worry survey group differences (MBCT and PMR)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Cognitive Therapy (MBCT)Experimental Treatment1 Intervention
MBCT is a "mindfulness-based intervention" group intervention involving in session and at home practicve of mindfulness meditation and other mindfulness practices. There are8 sessions each with a specific theme and and these are ~2 hours long. Over the 8-weeks participants will learn several mindfulness meditation techniques. Each session will involve group discussion and feedback. Participants will be asked to practice these techniques at home, and keep a log of mood, and stress ratings.
Audio files with exercises will be given to participants so that they can practice at home between sessions.
Group II: Muscle Relaxation TherapyActive Control1 Intervention
PMR is a relaxation-based group intervention similar to other relaxation interventions commonly used for anxiety and PTSD. It involves in session and at home practicve of relaxation techniques including tensing and relaxing muscle groups, but no specifici mindfulness or meta-cogntive awaremess instructions. This PMR group has been designed as an active comparator with similar stucture to MBCT, but without mindfulness instruction. There are 8 sessions each with a specific theme and these are ~2 hours long. Over the 8-weeks participants will learn several relaxation techniques. Each session will involve group discussion and feedback. Participants will be asked to practice these techniques at home, and keep a log of mood, and stress ratings.
Audio files with exercises will be given to participants so that they can practice at home between sessions.
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?
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,874 Total Patients Enrolled
Ohio State UniversityLead Sponsor
829 Previous Clinical Trials
505,684 Total Patients Enrolled
University of MichiganOTHER
1,796 Previous Clinical Trials
6,377,894 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently addicted to drugs or alcohol.You have a mental illness called psychosis.I have a history of experiencing trauma.You are experiencing high levels of stress and worry related to COVID-19, as measured by specific questionnaires.You have been diagnosed with schizophrenia in the past.You have a risk of committing suicide.You have post-traumatic stress disorder (PTSD).The study team and PI have decided that it is not safe or beneficial for you to participate in the study due to other reasons.You live in an area that has been severely affected by COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-Based Cognitive Therapy (MBCT)
- Group 2: Muscle Relaxation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the chief goals of this clinical research endeavor?
"The primary objective of the study is to evaluate therapeutic efficacy through Working Alliance Inventory-short revised (WAI-SR) scores. Secondary objectives pertaining to this measure include a comparison between MBCT and PMR groups, in addition to assessing anxiety using Patient Reported Outcomes Measurement Information System (PROMIS-adult short form level 2), and worry levels as determined by Penn State Worry Questionnaire (PSWQ-16). This evaluation phase will last up to 8 weeks."
Answered by AI
What is the maximum capacity of participants for this trial?
"Correct. According to clinicaltrials.gov, this study is still recruiting participants with the most recent update occurring on August 6th 2022. When first posted in October 2020 it sought 60 patients from 2 different sites for its trial."
Answered by AI
Is this research endeavor accepting new participants?
"According to the data available on clinicaltrials.gov, this trial is open for recruitment; it was initially posted on October 19th 2020 and had its most recent update on August 6th 2022."
Answered by AI
Am I an eligible participant for this clinical research?
"To be considered for enrollment, individuals must suffer from moral injury and have an age between 18 and 72 years. Sixty people will ultimately take part in this clinical study."
Answered by AI
Are individuals aged 45 or over permitted to partake in this clinical research?
"The cutoff for entry into this study is 18 years and the upper limit is 72 years of age."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
University of Michigan
The Ohio State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
What questions have other patients asked about this trial?
1. How much should I expect this trial to pay?
2. What length of time should I expect this trial to take in order to complete and receive compensation?
3. Will this trial require time outside of in-office visits at the Ann-Arbor trial location? If so, how much time and in what ways?
4. How long should I expect the screening process to take?
PatientReceived 1 prior treatment
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