Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Transcendental Meditation program

• Registration Number: NCT02791464
• Lead Sponsor: Maharishi International University

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.

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 Timeline

• Study Start: 2014-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-06
• Study First Submitted: 2016-06-01
• Study First Submitted QC: 2016-06-03
• Last Update Submitted: 2016-06-03
• Study First Posted: 2016-06-06
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transcendental Meditation	Transcendental Meditation program	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.

Primary Outcome Measures

Name	Time	Method
Posttraumatic Stress Checklist- Civilian Version (PCL-C) total score	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