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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: November 20, 2014
Last verified: November 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
Behavioral: Mantram Repetition Program (MRP) plus Usual Care
Other: Usual care consisting of medication and case management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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:
  • Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR [ Time Frame: Pre-treatment and post-treatment ] [ Designated as safety issue: No ]

    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.


  • PTST Checklist (PCL) Civilian Version [ Time Frame: Pre-treatment and Post-treatment ] [ 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. Items are rated from 0="not at all" to 5="extremely". Higher scores indicate greater severity and scores range from 17-85.


Secondary Outcome Measures:
  • Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score) [ Time Frame: Pre-treatment and post-treatment ] [ Designated as safety issue: No ]
    Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include "feeling calm and peaceful, having alot of energy, feeling downhearted and blue" -- all rated on a frequency scale from 1= "all of the time" to 6="none of the time." Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) "accomplishing less than you like" and (2) "not doing work or activies as carefully as usual" (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements.

  • Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)] [ Time Frame: Pre- & Post-Intervention ] [ Designated as safety issue: No ]
    FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of "feeling peaceful," "having meaning and purpose in life" and "finding comfort in faith or spiritual beliefs." Items are rated on a 5-point Likert scale: 0 = "not at all" and 4 = "very much". Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being.

  • 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. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. 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) General Activities [ Time Frame: Pre- & Post-Intervention ] [ Designated as safety issue: No ]
    Quality of Life Enjoyment & Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.

  • Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization [ Time Frame: Pre-treatment and Post-treatment ] [ Designated as safety issue: No ]
    The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.


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 + Usual Care
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
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.
Other: Usual care consisting of medication and case management
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
Active Comparator: Arm 2: Usual Care alone
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
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.

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

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
  • 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
  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
Results First Received: September 23, 2014
Last Updated: November 20, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2014