N/A
Completed N=146
Mantram Repetition to Manage PTSD in Veterans
Stress Disorders, Post Traumatic
Source: ClinicalTrials.gov NCT00120627 ↗
Enrolled (actual)
146
Serious AEs
—
Results posted
Nov 2014
Primary outcomePrimary: Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR — 83.08; 82.83; 66.16; 72.59 units on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR |
83.08; 82.83; 66.16; 72.59 | <0.05 sig |
| PRIMARY PTST Checklist (PCL) Civilian Version |
61.39; 62.70; 55.77; 60.23 | < 0.05 sig |
| SECONDARY Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score) |
33.15; 32.89; 36.30; 33.17 | <0.05 sig |
| SECONDARY Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)] |
22.30; 20.59; 26.72; 20.04 | <0.0001 sig |
| SECONDARY Mindfulness Attention Awareness Scale (MAAS) |
46.60; 47.80; 50.99; 46.04 | <0.001 sig |
| SECONDARY Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities |
35.52; 34.98; 39.34; 35.75 | <0.01 sig |
| SECONDARY Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization |
12.52; 12.32; 10.60; 12.24; 12.15; 11.98 | <0.001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00120627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.