Clinical trial NCT00120627: Mantram Repetition to Manage PTSD in Veterans
Official title: Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post Traumatic
Keywords: Randomized Controlled Trial
Intervention Study
Mindfulness
Complementary Therapy
Mind-Body Relations (Metaphysics)
Spiritual Therapy
Meditation
Qualitative Analysis
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-18
Enrollment: 146
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: With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat veterans is increasing. Creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with PTSD. Surveys indicate that veterans are interested in complementary approaches to health care. The purpose of this study is to determine the efficacy of the Mantram Repetition Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual associations, to manage PTSD symptoms and improve quality of life military veterans with trauma.

Detailed description: The Mantram Repetition Program (MRP) is an innovative, portable meditation-based group intervention. In this study, the MRP was delivered in addition to usual care (defined as case management and medication) in a 6-week (90 minutes/week) group setting. The MRP was compared to usual care only.

This 4-year study employed a mixed-methods, prospective, randomized controlled trial with qualitative phone interviews at 3 months post-intervention to explore ways that the intervention was used. Outpatient Veterans (N=146) with military-related PTSD were recruited from a single VA site and randomly assigned to the experimental arm (n=71) which consisted of usual care and the mantram program versus usual care only control group (n=76).

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of PTSD, military related
* Score of greater or equal to 45 on the Clinician Administered PTSD Scale
* Read and write English
* Score of \> 50 on PTSD Checklist
* Has a telephone with answering machine or voice mail to receive study messages
* Has a Case Manager assigned for usual care
* Willingness to track medications, relaxation techniques and number of case manager visit

Exclusion Criteria:

* Cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation
* Presence of active, serious suicidal ideation

Primary outcomes:
measure: Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
timeFrame: Pre-treatment and post-treatment
measure: PTST Checklist (PCL) Civilian Version
timeFrame: Pre-treatment and Post-treatment
Secondary outcomes:
measure: Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
timeFrame: Pre-treatment and post-treatment
measure: Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
timeFrame: Pre- & Post-Intervention
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: Baseline, Post-Intervention
measure: Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
timeFrame: Pre- & Post-Intervention
measure: Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
timeFrame: Pre-treatment and Post-treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Jill E Bormann, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bormann JE. Frequent, Silent Mantram Repetition: A Jacuzzi for the Mind. Topics in Emergency Medicine. 2005 Apr 1; 27(2):163-166.
citation: Bormann JE, Thorp S, Wetherell JL, Golshan S. A spiritually based group intervention for combat veterans with posttraumatic stress disorder: feasibility study. J Holist Nurs. 2008 Jun;26(2):109-16. doi: 10.1177/0898010107311276. Epub 2008 Mar 20.
citation: Bormann JE, Smith TL, Shively M, Dellefield ME, Gifford AL. Self-monitoring of a stress reduction technique using wrist-worn counters. J Healthc Qual. 2007 Jan-Feb;29(1):45-52. doi: 10.1111/j.1945-1474.2007.tb00175.x.
citation: Bormann JE, Smith TL, Becker S, Gershwin M, Pada L, Grudzinski AH, Nurmi EA. Efficacy of frequent mantram repetition on stress, quality of life, and spiritual well-being in veterans: a pilot study. J Holist Nurs. 2005 Dec;23(4):395-414. doi: 10.1177/0898010105278929.
citation: Bormann JE, Hurst S, Thorp SR, Glaser D. Spiritually-Based Mantram Repetition to Manage PTSD in Veterans: A Qualitative Analysis of Use and Outcomes. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2010 Apr 1; 39(Suppl 1):216.
citation: Bormann JE, Liu L, Thorp SR, Lang AJ. Spiritual wellbeing mediates PTSD change in veterans with military-related PTSD. Int J Behav Med. 2012 Dec;19(4):496-502. doi: 10.1007/s12529-011-9186-1.
citation: Bormann JE. Spiritual well-being and PTSD symptoms in veterans: A predictive model. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2009 Dec 1; Suppl:114.
citation: Bormann JE, Hurst S, Kelly A. Responses to Mantram Repetition Program from Veterans with posttraumatic stress disorder: a qualitative analysis. J Rehabil Res Dev. 2013;50(6):769-84. doi: 10.1682/JRRD.2012.06.0118.
citation: Lang AJ, Strauss JL, Bomyea J, Bormann JE, Hickman SD, Good RC, Essex M. The theoretical and empirical basis for meditation as an intervention for PTSD. Behav Modif. 2012 Nov;36(6):759-86. doi: 10.1177/0145445512441200. Epub 2012 Jun 5.
citation: Bormann JE, Thorp SR, Wetherell JL, Golshan S, Lang AJ. Meditation-Based Mantram Intervention for Veterans with Posttraumatic Stress Disorder: A Randomized Trial. Psychological trauma : theory, research, practice and policy. 2013 Jan 1; 5(3):259-267.
citation: Bormann JE, Oman D, Walter KH, Johnson BD. Mindful attention increases and mediates psychological outcomes following mantram repetition practice in veterans with posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S13-8. doi: 10.1097/MLR.0000000000000200.