Mantram Repetition Meditation for Veterans With PTSD

US Department of Veterans Affairs (VA)

Status and phase: Completed; Phase 3

Conditions: Stress Disorders, Post-Traumatic

Treatments: Behavioral: Mantram Repetition Program (MRP); Behavioral: Present Centered Therapy (PCT)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01506323

SPLE-003-11S

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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181 participants in 2 patient groups

Mantram Repetition Program (MRP)

Experimental group

Description:

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.

Treatment:

Behavioral: Mantram Repetition Program (MRP)

Present Centered Therapy (PCT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Present Centered Therapy (PCT)