VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161, United States
NCT Number: NCT00120627
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92161, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
Time frame: Pre-treatment and post-treatment
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.
Time frame: Pre-treatment and Post-treatment
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.
Time frame: Pre-treatment and post-treatment
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.
Time frame: Pre- & Post-Intervention
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.
Time frame: Baseline, Post-Intervention
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.
Time frame: Pre- & Post-Intervention
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.
Time frame: Pre-treatment and Post-treatment
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.
US Department of Veterans Affairs
Fed
Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
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