Clinical trial NCT01506323: Mantram Repetition Meditation for Veterans With PTSD
Official title: Portable Mantram Meditation for Veterans With Military Related PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Disorders, Post-Traumatic
Keywords: Complementary Therapy
Stress Disorders, Post-Traumatic
Veterans Health
Clinical Trials, Randomized
Mindfulness
Spirituality
Meditation
Mind-body therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-01-10
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)
timeFrame: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
measure: Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)
timeFrame: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
measure: Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)
timeFrame: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
measure: Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)
timeFrame: Baseline to post-treatment (week 8); baseline to 2 months post-treatment.
measure: PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]
timeFrame: Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline to post-treatment (week 8); baseline to 2 months post-treatment.
measure: Patient Health Questionnaire (PHQ-9) for Depression
timeFrame: Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.
measure: Spielberger State Anger Inventory-Short Form
timeFrame: Baseline to post-treatment (week 8); baseline to 2-months post-treatment.
measure: Spielberger Trait Anger Inventory-Short Form
timeFrame: Baseline to post-treatment (week 8); baseline to 2-months post-treatment.
measure: Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)
timeFrame: Baseline to post-treatment (week 8); baseline to 2-months post-treatment.
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to post-treatment (week 8); baseline to 2-months follow-up.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
state: Massachusetts
Study officials:
affiliation: San Diego Veterans Healthcare System
name: Jill E. Bormann, PhD RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Edith Nourse Rogers Memorial Veterans Hospital
name: A. Rani Elwy, PhD MSc BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bormann JE, Plumb DN, Beck DJ, Glickman M, Zhao S, Osei-Bonsu PE, Johnston JM, Herz L, Elwy AR. Portable meditation-based mantram program reduces PTSD symptoms in veterans: A randomized controlled trial. Poster session presented at: International Society for Traumatic Stress Studies Annual Symposium; 2014 Nov 1; Miami, FL.
citation: Malaktaris A, McLean CL, Mallavarapu S, Herbert MS, Kelsven S, Bormann JE, Lang AJ. Higher frequency of mantram repetition practice is associated with enhanced clinical benefits among United States Veterans with posttraumatic stress disorder. Eur J Psychotraumatol. 2022 Jun 10;13(1):2078564. doi: 10.1080/20008198.2022.2078564. eCollection 2022.
citation: Bormann JE, Thorp SR, Smith E, Glickman M, Beck D, Plumb D, Zhao S, Ackland PE, Rodgers CS, Heppner P, Herz LR, Elwy AR. Individual Treatment of Posttraumatic Stress Disorder Using Mantram Repetition: A Randomized Clinical Trial. Am J Psychiatry. 2018 Oct 1;175(10):979-988. doi: 10.1176/appi.ajp.2018.17060611. Epub 2018 Jun 20.