Mantram Repetition Meditation for Veterans With PTSD

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-06-30

Brief Summary

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The aim of this study was to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego, California, and Bedford, Massachusetts.

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Detailed Description

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The investigators conducted a prospective, parallel group, two-site, randomized clinical trial on the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control condition of Present Centered Therapy (PCT) in a diverse sample of Veterans with post-traumatic stress disorder (PTSD). Primary outcomes included clinician-assessed and self-reported PTSD symptom severity. Secondary outcomes included insomnia, depression, anger, spiritual well-being, and mindfulness. Veterans were were recruited from a variety of clinics, including primary care, women's health, and specialty clinics in two geographical locations within the Department of Veterans Affairs healthcare system.

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mantram Repetition Program (MRP)

A portable meditation-based "Mantram Repetition Program (MRP)" will be delivered individually in 8-weekly 1 hour sessions to teach a set of strategies for training attention to manage symptoms. For this study, the program targets symptoms of posttraumatic stress disorder (PTSD) in Veterans who have experienced military-related trauma.

Group Type EXPERIMENTAL

Mantram Repetition Program (MRP)

Intervention Type BEHAVIORAL

The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.

Present Centered Therapy (PCT)

Present Centered Therapy (PCT) is a form of individually-delivered 8-weekly, 1 hour sessions that are problem-oriented to improve current coping. For this study, it served as an attention control arm for the non-specific effects of individual therapist interaction.

Group Type ACTIVE_COMPARATOR

Present Centered Therapy (PCT)

Intervention Type BEHAVIORAL

The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.

Interventions

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Mantram Repetition Program (MRP)

The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.

Intervention Type BEHAVIORAL

Present Centered Therapy (PCT)

The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.

Intervention Type BEHAVIORAL

Other Intervention Names

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MRP, Mantram Meditation PCT

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Read and write English fluently
* Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma
* Transportation to attend meetings and available to complete study protocols
* Stable dose and type of PTSD medications for at least 6 weeks (per chart review)
* Willing to track medication changes during study

Exclusion Criteria

* Inability to give informed, voluntary consent
* Cognitive impairment sufficient to cause inability to complete the protocol
* Psychotic symptoms
* Dementia or other organic mental disorders that may cause inability to complete the protocol
* Significant documented alcohol/substance abuse
* Presence of severe suicidal urges or intent
* Residence in a geographical area outside of San Diego County or Bedford, Massachusetts area
* Current daily practice of any skills of any meditation-based program - including, but not limited to:

* Transcendental Meditation (TM)
* Yoga
* Tai Chi
* Qi-Gong
* Vipassana or Insight Meditation
* Loving-Kindness or Compassion Meditation
* Mindfulness-Based Stress Reduction (MBSR) or other mindfulness program
* Guided Imagery
* Mantram Repetition
* Passage Meditation
* Walking Meditation
* Zen or Buddhist meditation
* Self-hypnosis, Bio-feedback, etc.
* Other participant circumstances that, in the opinion of a consensus of the study team, would interfere with the safety of prospective participants or their need for treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No