Mantram Repetition to Manage PTSD in Veterans

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy of Mantram Repetition on PTSD Symptoms in Veterans

Conditions
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Stress Disorders, Post Traumatic

Intervention / Treatment
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* Behavioral: Mantram Repetition Program (MRP) plus Usual Care
* Other: Usual care consisting of medication and case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Mantram + Usual Care<br>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<br>* 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.<br>Other: Usual care consisting of medication and case management<br>* Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.<br>|
| Active Comparator: Arm 2: Usual Care alone<br>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<br>* Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score) | 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. | Pre-treatment and post-treatment | 
| Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)] | 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. | Pre- & Post-Intervention | 
| Mindfulness Attention Awareness Scale (MAAS) | 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. | Baseline, Post-Intervention | 
| Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities | 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. | Pre- & Post-Intervention | 
| Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization | 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. | Pre-treatment and Post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Intervention Study, Mindfulness, Complementary Therapy, Mind-Body Relations (Metaphysics), Spiritual Therapy, Meditation, Qualitative Analysis