Mantram Repetition to Manage PTSD in Veterans - Full Text View

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 a brief, 6-week, complementary and portable intervention of frequent, silent repetition of a mantram (mantra), a word or phrase with spiritual associations, on reducing PTSD symptoms and improving quality of life in military veterans.

Condition	Intervention
Stress Disorders, Post Traumatic	Behavioral: Mantram Repetition

MedlinePlus related topics:

Post-Traumatic Stress Disorder Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study

Official Title:	Efficacy of Mantram Repetition on PTSD Symptoms in Veterans

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Severity of PTSD symptoms and psychological distress will be assessed in a clinical interview and by self-report rating scales of PTSD and distress at post-intervention and 6 week follow-up. Telephone interviews will be conducted 3 months after [ Time Frame: Baseline, Post-Intervention, 6-week Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life and spiritual well-being will assessed using self-report rating scales at post-intervention and 6 week follow-up. Telephone interviews will be conducted 3 months after follow-up to assess the impact of the intervention on quality of life. [ Time Frame: Baseline, Post-Intervention, 6-week Follow-up ] [ Designated as safety issue: No ]
Brief Pain Inventory [ Time Frame: Baseline, Post-Intervention, 6-week Follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	November 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 6-week, 90-minute per week, facilitator led psycho-education and training in complementary therapy of mantram repetition.	Behavioral: Mantram Repetition Mantram is a word or phrase chosen by study participant to be used for silent repetition throughout the day or night to train attention and calm the mind.
2: No Intervention Usual care

Detailed Description:

Individuals who suffer from PTSD typically experience intrusive, negative thoughts that both provoke and are exacerbated by symptoms of depression and anxiety. Mantram repetition is a therapeutically innovative, nonpharmacological, easy-to-implement technique that has the potential to significantly and cost-effectively improve mental health and quality of life in emotionally traumatized patients. This group intervention is offered in a shorter, 6-week intervention, and incorporates spirituality as a coping resource.

A randomized, controlled clinical trial will be used to compare a mantram group intervention to a delayed treatment control group on outcomes of self-reported PTSD symptoms, psychological distress, and quality of life. 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.

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120627

Contacts


Contact: Patricia Bone, RN BS	(858) 552-8585 ext 2378	patricia.bone@va.gov

Contact: Jill E Bormann, PhD RN CS	(858) 552-8585 ext 2378	jill.bormann@va.gov

Locations


United States, California
	VA San Diego Health Care System	Recruiting
	San Diego, California, United States, 92161
	Contact: Patricia Bone, RN BS (858) 552-8585 ext 2378 patricia.bone@va.gov
	Contact: Jill E Bormann, PhD RN CS (858) 552-8585 ext 2378 jill.bormann@va.gov
	Principal Investigator: Jill E. Bormann, PhD RN CS
	Sub-Investigator: Martha J. Shively, PhD RN
	Sub-Investigator: Mary Ellen Dellefield, PhD BSN MS

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Jill E. Bormann, PhD RN CS	VA San Diego Health Care System

More Information

Publications of Results:

Bormann JE, Thorp S, Wetherell JL, Golshan S. A spiritually based group intervention for combat veterans with posttraumatic stress disorder: feasibility study. J Holist Nurs. 2008 Jun;26(2):109-16. Epub 2008 Mar 20.

Other Publications:

Bormann JE, Smith TL, Becker S, Gershwin M, Pada L, Grudzinski AH, Nurmi EA. Efficacy of frequent mantram repetition on stress, quality of life, and spiritual well-being in veterans: a pilot study. J Holist Nurs. 2005 Dec;23(4):395-414.

Bormann JE, Oman D, Kemppainen JK, Becker S, Gershwin M, Kelly A. Mantram repetition for stress management in veterans and employees: a critical incident study. J Adv Nurs. 2006 Mar;53(5):502-12.

Bormann JE, Smith TL, Shively M, Dellefield ME, Gifford AL. Self-monitoring of a stress reduction technique using wrist-worn counters. J Healthc Qual. 2007 Jan-Feb;29(1):45-52.

Responsible Party:	Department of Veterans Affairs ( Bormann, Jill - Principal Investigator )
Study ID Numbers:	NRI 04-041
First Received:	July 12, 2005
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00120627
Health Authority:	United States: Federal Government