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. This is a 4-year plan to study the efficacy of a brief, 6-week, complementary and portable intervention of frequent, silent repetition of a mantram (mantra), a word or phrase with or without spiritual associations, to manage severity of PTSD symptoms and improve quality of life in military veterans. A randomized, controlled clinical trial (N=140) will be conducted to compare a mantram group intervention (n = 70) to a delayed treatment control group (n = 70) on outcomes of self-reported PTSD symptoms, psychological distress, and quality of life. Outpatient veterans with military-related PTSD will be recruited and randomized to either intervention or delayed treatment control group. The intervention will be given over 6-weeks, 90-minutes per week in small groups. Mantram repetition will be measured using a wrist-watch counter and tracking logs. Outcomes of PTSD symptom severity, psychological distress, and quality of life will be assessed using Clinician Administered PTSD Scale (CAPS), PTSD Checklist, Spielberger Anger Inventory, SF-36 Health Survey, and Functional Assessment of Chronic Illness Existential Spirituality Scale at pre-intervention, post-intervention, and 6 week follow-up. Intervention efficacy will be assessed using 2 (group) by 2 (time) repeated measure design. Within intervention group comparisons will be examined at pre-intervention and week 12. Qualitative tape-recorded phone interviews will be conducted at week 24 to assess situations where the intervention was either helpful or not helpful. Qualitative interviews will be analyzed using critical incident technique.

Condition	Intervention
Stress Disorders, Post Traumatic	Behavior: Frequent, silent mantram repetition

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Primary diagnosis of PTSD, military related
• Read and write English
• Score higher than 23 on Mini Mental Status Exam
• Score higher than 50 on Clinician Administered PTSD Scale
• Score higher than 20 on Brief Symptom Inventory-18
• Clean and sober for at least 2 months
• 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 visits

Please refer to this study by ClinicalTrials.gov identifier  NCT00120627

California
      VA San Diego Health Care System, San Diego,  California,  92161,  United States

Study ID Numbers:  NRI 04-041
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120627
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26