Mantram Repetition to Manage PTSD in Veterans

NCT00120627 | Completed Results

• 1 other identifier: NRI 04-041
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post Traumatic

Keywords

Randomized Controlled Trial; Intervention Study; Mindfulness; Complementary Therapy; Mind-Body Relations (Metaphysics); Spiritual Therapy; Meditation; Qualitative Analysis

Outcome Measures

Primary Outcomes (2)

• Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR

  The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0="never" to 4="daily or almost everyday." The items for intensity are rated from 0="none" to 4="extreme." Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis. The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms.

  Pre-treatment and post-treatment

• PTST Checklist (PCL) Civilian Version

  The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0="not at all" to 5="extremely". Higher scores indicate greater severity and scores range from 17-85.

  Pre-treatment and Post-treatment

Secondary Outcomes (5)

• Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)

  Pre-treatment and post-treatment

• Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]

  Pre- & Post-Intervention

• Mindfulness Attention Awareness Scale (MAAS)

  Baseline, Post-Intervention

• Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities

  Pre- & Post-Intervention

• Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization

  Pre-treatment and Post-treatment

Study Arms (2)

Arm 1: Mantram + Usual Care

EXPERIMENTAL

Mantram Repetition Program for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.

Behavioral: Mantram Repetition Program (MRP) plus Usual Care; Other: Usual care consisting of medication and case management

Arm 2: Usual Care alone

ACTIVE COMPARATOR

Usual care alone is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.

Other: Usual care consisting of medication and case management

Interventions

Mantram Repetition Program (MRP) plus Usual Care BEHAVIORAL

The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A "mantram" is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.

Arm 1: Mantram + Usual Care

Usual care consisting of medication and case management OTHER

Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.

Arm 1: Mantram + Usual Care; Arm 2: Usual Care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (11)

• Bormann JE. Frequent, Silent Mantram Repetition: A Jacuzzi for the Mind. Topics in Emergency Medicine. 2005 Apr 1; 27(2):163-166.

  BACKGROUND

• 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.

  PMID: 18356284 BACKGROUND

• 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.

  PMID: 17518033 BACKGROUND

• 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.

  PMID: 16251489 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 21874605 RESULT

• 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.

  RESULT

• 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.

  PMID: 24203540 RESULT

• 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.

  PMID: 22669968 RESULT

• 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.

  RESULT

• 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.

  PMID: 25397817 DERIVED

MeSH Terms

Conditions

Combat Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Jill E. Bormann, PhD, RN, FAAN
• Organization: VA San Diego Healthcare System

jill.bormann@va.gov

858-552-8585

Study Officials

• Jill E Bormann, PhD RN

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2005
• First Posted: July 18, 2005
• Study Start: November 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: September 1, 2010
• Last Updated: April 28, 2015
• Results First Posted: November 27, 2014

Record last verified: 2014-08

Locations

US (1)