- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791464
Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates
June 3, 2016 updated by: Sanford Nidich, Maharishi International University
Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates: A Randomized Controlled Pilot Study
The pilot study investigates the potential benefits of the Transcendental Meditation program in reducing trauma, including PTSD, in female prisoners.
Subjects will be randomly assigned to either the TM program or a wait list control group for a period of four months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled pilot study will evaluate the effects of Transcendental Meditation ® (TM) on female offenders with trauma.
Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, Oregon, with at least four months left of incarceration, will be enrolled in the study.
Subjects will be randomly assigned to either a TM (n=11) or a wait-list control group (n=11).
Subjects will be measured at baseline and four-month posttest, using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C) Twenty of the subjects (10 in each group) will take part in their treatment assignment and complete post-testing.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female inmates, at least 4 months left of incarceration, signed written informed consent prior to baseline testing
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: wait list control
Waitlist control subjects interested in learning the TM program will be asked to wait for 4 months before learning if they were randomly assigned to this comparison group.
Controls will receive usual medical care during 4 month intervention period.
|
|
Experimental: Transcendental Meditation
The TM technique is a simple, effortless, mental technique to reducing stress which allows the mind to experience finer levels of the thinking process to achieve a state of restful alertness.
The Transcendental Meditation program will be taught as a standard seven-step program over five consecutive days.
|
a mental technique using a mantra or 'soothing sound' that refines the thought process enabling the mind to 'transcend' its own thinking process and experience a state of pure consciousness.
Subjects practice this technique twice a day for 20 minutes sitting in chair with eyes closed.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Posttraumatic Stress Checklist- Civilian Version (PCL-C) total score
Time Frame: 4 months
|
The PCL-C is a widely-used 17-item self-report questionnaire of trauma symptom with total score and intrusions, avoidance and hyperarousal subscales
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Fred Travis, PhD, Maharishi University of Management Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
June 1, 2016
First Submitted That Met QC Criteria
June 3, 2016
First Posted (Estimate)
June 6, 2016
Study Record Updates
Last Update Posted (Estimate)
June 6, 2016
Last Update Submitted That Met QC Criteria
June 3, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLF1008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
inquiring investigators may contact the principal investigator, Dr Sanford Nidich, for data share plans.
Database resides with the PI and the biostatistician
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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