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Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

Primary Purpose

Stress Disorders, Post-Traumatic

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Transcendental Meditation program

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Meditation, TM, PTSD, Trauma, Female Prisoners

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

none

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

wait list control

Transcendental Meditation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

The PCL-C is a widely-used 17-item self-report questionnaire of trauma symptom with total score and intrusions, avoidance and hyperarousal subscales

Secondary Outcome Measures

Full Information

NCT ID

NCT02791464

First Posted

June 1, 2016

Last Updated

June 3, 2016

Sponsor

Maharishi International University

Collaborators

Western Oregon University, Maharishi University of Management Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02791464

Brief Title

Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

Official Title

Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates: A Randomized Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Maharishi International University

Collaborators

Western Oregon University, Maharishi University of Management Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

Keywords

Meditation, TM, PTSD, Trauma, Female Prisoners

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

wait list control

Arm Type

No Intervention

Arm Description

Arm Title

Transcendental Meditation

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Transcendental Meditation program

Other Intervention Name(s)

TM technique

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

The PCL-C is a widely-used 17-item self-report questionnaire of trauma symptom with total score and intrusions, avoidance and hyperarousal subscales

Time Frame

4 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: female inmates, at least 4 months left of incarceration, signed written informed consent prior to baseline testing Exclusion Criteria: none

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred Travis, PhD

Organizational Affiliation

Maharishi University of Management Research Institute

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

inquiring investigators may contact the principal investigator, Dr Sanford Nidich, for data share plans. Database resides with the PI and the biostatistician

Learn more about this trial

Transcendental Meditation and Reduced Trauma Symptoms in Women Inmates

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