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Phase 3 N=173 Randomized Single-blind Treatment

Mantram Repetition Meditation for Veterans With PTSD

Stress Disorders, Post-Traumatic

Bottom Line

View on ClinicalTrials.gov: NCT01506323 ↗
Enrolled (actual)
173
Serious AEs
2.3%
Results posted
Sep 2015
Primary outcome: Primary: Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) — 77.46; 75.61; 52.39; 62.07 units on a scale — p=<.006

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Mantram Repetition Program (MRP) (Behavioral); Present Centered Therapy (PCT) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
US Department of Veterans Affairs
Primary completion
Mar 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)		 77.46; 75.61; 52.39; 62.07; 50.62; 59.00 <.006 sig
PRIMARY
Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)		 20.74; 21.80; 14.40; 15.78; 14.32; 15.94 0.82
PRIMARY
Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)		 29.92; 29.13; 19.91; 24.13; 18.67; 21.78 <0.008 sig
PRIMARY
Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)		 25.01; 24.64; 18.01; 21.70; 17.61; 21.01 <.006 sig
PRIMARY
PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]		 59.23; 57.57; 45.32; 50.20; 44.74; 48.42 <0.04 sig
SECONDARY
Insomnia Severity Index (ISI)		 18.33; 16.34; 14.22; 16.62; 12.73; 15.92 <0.0008 sig
SECONDARY
Patient Health Questionnaire (PHQ-9) for Depression		 15.42; 15.15; 10.68; 12.81; 10.57; 12.18 <0.10
SECONDARY
Spielberger State Anger Inventory-Short Form		 23.43; 12.00; 21.21; 22.20; 21.22; 21.27 <0.78
SECONDARY
Spielberger Trait Anger Inventory-Short Form		 22.34; 21.89; 20.90; 10.37; 19.53; 18.62 <0.99
SECONDARY
Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)		 43.69; 44.74; 50.41; 46.28; 50.95; 47.80 <0.12
SECONDARY
Five Facet Mindfulness Questionnaire (FFMQ)		 121.34; 118.39; 121.29; 116.75; 120.43; 119.00 <0.59

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01506323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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