Mantram Repetition Meditation for Veterans With PTSD
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Mantram Repetition Program (MRP); Present Centered Therapy (PCT)
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Complementary Therapy; Stress Disorders, Post-Traumatic; Veterans Health; Clinical Trials, Randomized; Mindfulness; Spirituality; Meditation; Mind-body therapy

Summary:

      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.
    

Eligibility criteria:

        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.