Mantram Repetition to Manage PTSD in Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00120627
First received: July 12, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Stress Disorders, Post Traumatic
Veterans
Behavioral: Mantram Repetition Program (MRP)
Other: Usual care consisting of medication and case management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Mantram Repetition on PTSD Symptoms in Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PTST Checklist (PCL) & Clinician Administered PTSD Scale (CAPS) [ Time Frame: Baseline, Post-Intervention & (6-week FU in MRP) ] [ Designated as safety issue: No ]
    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. The CAPS is used to determine symptom severity and PTSD diagnosis.


Secondary Outcome Measures:
  • SF-12 Health Quality of Life and Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp) [ Time Frame: Baseline, Post-Intervention ] [ Designated as safety issue: No ]

    SF-12 measures health-related quality of life changes in mental, physical health from SF-36 scales:

    • physical functioning
    • role limitations- physical problems
    • bodily pain
    • general health perceptions
    • energy
    • vitality
    • social functioning
    • role limitations- emotional problems
    • mental health Summary scores explain 90% variance of SF-36 component scores. FACIT-SWB assesses spiritual components using 23 items rated on a 5-point Likert scale; high scores reflect greater spiritual well-being. Validity of Pearson correlations measures quality of life, mood, religious growth.

  • Brief Symptom Inventory-18 (BSI-18) for anxiety and depression [ Time Frame: Baseline, Post-Intervention ] [ Designated as safety issue: No ]
    Brief Symptom 18 Item Inventory (BSI-18) is a highly sensitive self-report symptom inventory that screens for psychological distress and psychiatric disorders. It contains 18 items scored on a 5-point Likert scale and has three subscales of depression, anxiety and somatization.

  • Mindfulness Attention Awareness Scale (MAAS) [ Time Frame: Baseline, Post-Intervention ] [ Designated as safety issue: No ]
    The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.

  • Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: Pre- & Post-Intervention ] [ Designated as safety issue: No ]
    Q-LES-Q general scale measures quality of life and satisfaction of 14 domains.

  • Spiritual well-being [Functional Assessment of Chronic Illness Therapy (FACIT-Sp)] [ Time Frame: Pre- & Post-Intervention ] [ Designated as safety issue: No ]
    This is a measure of existential spiritual well-being that has subscales measuring peace/meaning and faith/assurance.

  • Spiritual well-being (Functional Assessment of Chronic Illness Therapy (FACIT-Sp) [ Time Frame: Pre- & Post-Intervention ] [ Designated as safety issue: No ]
    This is a measure of existential spiritual well-being that has subscales measuring peace/meaning and faith/assurance.


Enrollment: 146
Study Start Date: November 2005
Study Completion Date: September 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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)
The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. In this study, it was delivered in a 6-week (90 minutes/week) group setting that consists of information, experiential learning and homework. 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.
Other Name: Mantram Repetition Program (MRP)
Arm 2
Usual care consisting of medication and case-management.
Other: Usual care consisting of medication and case management
Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Other Name: Usual Care

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). Outcome measures included the PTSD Checklist (PCL), Clinician Administered PTSD Scale (CAPS), Brief Symptom Inventory-18, SF-12 Health Survey, Functional Assessment of Chronic Illness Existential Spirituality Scale (FACIT-Sp) and the Mindfulness Attention Awareness Scale (MAAS).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of PTSD, military related
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120627

Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Jill E. Bormann, PhD RN San Diego Veterans Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00120627     History of Changes
Other Study ID Numbers: NRI 04-041
Study First Received: July 12, 2005
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Randomized Controlled Trial
Intervention Study
Treatment Efficacy
Complementary Therapy
Mind-Body Relations (Metaphysics)
Spiritual Therapy
Nursing
Qualitative Analysis

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014