NCT02791464

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
Last Updated

June 6, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

June 1, 2016

Last Update Submit

June 3, 2016

Conditions

Keywords

MeditationTMPTSDTraumaFemale Prisoners

Outcome Measures

Primary Outcomes (1)

  • 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

    4 months

Study Arms (2)

wait list control

NO INTERVENTION

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.

Transcendental Meditation

EXPERIMENTAL

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

Interventions

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.

Also known as: TM technique
Transcendental Meditation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Fred Travis, PhD

    Maharishi University of Management Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Director

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 6, 2016

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

June 6, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

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