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Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

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ClinicalTrials.gov Identifier: NCT02791464
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Collaborators:
Western Oregon University
Maharishi University of Management Research Institute
Information provided by (Responsible Party):
Sanford Nidich, Maharishi University of Management

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Transcendental Meditation program Not Applicable

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates: A Randomized Controlled Pilot Study
Study Start Date : March 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
Behavioral: Transcendental Meditation program
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 Name: TM technique



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female inmates, at least 4 months left of incarceration, signed written informed consent prior to baseline testing

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791464


Sponsors and Collaborators
Maharishi University of Management
Western Oregon University
Maharishi University of Management Research Institute
Investigators
Study Chair: Fred Travis, PhD Maharishi University of Management Research Institute

Responsible Party: Sanford Nidich, Principal Investigator, Associate Director, Maharishi University of Management
ClinicalTrials.gov Identifier: NCT02791464     History of Changes
Obsolete Identifiers: NCT03232060
Other Study ID Numbers: DLF1008
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: inquiring investigators may contact the principal investigator, Dr Sanford Nidich, for data share plans. Database resides with the PI and the biostatistician

Keywords provided by Sanford Nidich, Maharishi University of Management:
Meditation
TM
PTSD
Trauma
Female Prisoners

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders