Expired Study
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San Diego, California 92161


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 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.


Study summary:

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). Outcome measures included the PTSD Checklist (PCL), Clinician Administered PTSD Scale (CAPS), Brief Symptom Inventory-18, SF-12 Health Survey, Functional Assessment of Chronic Illness Existential Spirituality Scale (FACIT-Sp) and the Mindfulness Attention Awareness Scale (MAAS).


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


Study is Available At:


Original ID:

NRI 04-041


NCT ID:

NCT00120627


Secondary ID:


Study Acronym:


Brief Title:

Mantram Repetition to Manage PTSD in Veterans


Official Title:

Efficacy of Mantram Repetition on PTSD Symptoms in Veterans


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

146


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jill E. Bormann, PhD RN
Principal Investigator
San Diego Veterans Healthcare System

Study Dates

Start Date:November 2005
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:August 2014
Last Changed Date:August 11, 2014
First Received Date:July 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Spiritual well-being (Functional Assessment of Chronic Illness Therapy (FACIT-Sp)
Time Frame:Pre- & Post-Intervention
Safety Issues:False
Description:This is a measure of existential spiritual well-being that has subscales measuring peace/meaning and faith/assurance.
Outcome Type:Secondary Outcome
Measure:Spiritual well-being [Functional Assessment of Chronic Illness Therapy (FACIT-Sp)]
Time Frame:Pre- & Post-Intervention
Safety Issues:False
Description:This is a measure of existential spiritual well-being that has subscales measuring peace/meaning and faith/assurance.
Outcome Type:Secondary Outcome
Measure:Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q)
Time Frame:Pre- & Post-Intervention
Safety Issues:False
Description:Q-LES-Q general scale measures quality of life and satisfaction of 14 domains.
Outcome Type:Secondary Outcome
Measure:Mindfulness Attention Awareness Scale (MAAS)
Time Frame:Baseline, Post-Intervention
Safety Issues:False
Description: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. Mindfulness has been linked to well-being and quality
Outcome Type:Secondary Outcome
Measure:Brief Symptom Inventory-18 (BSI-18) for anxiety and depression
Time Frame:Baseline, Post-Intervention
Safety Issues:False
Description:Brief Symptom 18 Item Inventory (BSI-18) is a highly sensitive self-report symptom inventory that screens for psychological distress and psychiatric disorders. It contains 18 items scored on a 5-point Likert scale and has three subscales of depression, a
Outcome Type:Secondary Outcome
Measure:SF-12 Health Quality of Life and Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)
Time Frame:Baseline, Post-Intervention
Safety Issues:False
Description:SF-12 measures health-related quality of life changes in mental, physical health from SF-36 scales: physical functioning role limitations- physical problems bodily pain general health perceptions energy vitality social functioning role limitations
Outcome Type:Primary Outcome
Measure:PTST Checklist (PCL) & Clinician Administered PTSD Scale (CAPS)
Time Frame:Baseline, Post-Intervention & (6-week FU in MRP)
Safety Issues:False
Description: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. The CAPS is used to determine symptom severity and PTSD diagnosis.

Study Interventions

Intervention Type:Behavioral
Name:Mantram Repetition Program (MRP)
Description:The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. In this study, it was delivered in a 6-week (90 minutes/week) group setting that consists of information, experiential learning and homework. 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-poi
Arm Name:Arm 1
Other Name:Mantram Repetition Program (MRP)
Intervention Type:Other
Name:Usual care consisting of medication and case manag
Description:Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Arm Name:Arm 2
Other Name:Usual Care

Study Arms

Study Arm Type:Experimental
Arm Name:Arm 1
Description: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.
Study Arm Type:Other
Arm Name:Arm 2
Description:Usual care consisting of medication and case-management.

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Bormann JE, Hurst S, Kelly A. Responses to Mantram Repetition Program from Veterans with posttraumatic stress disorder: a qualitative analysis. J Rehabil Res Dev. 2013;50(6):769-84. doi: 10.1682/JRRD.2012.06.0118.
PMID:24203540
Reference Type:Results Reference
Citation:Lang AJ, Strauss JL, Bomyea J, Bormann JE, Hickman SD, Good RC, Essex M. The theoretical and empirical basis for meditation as an intervention for PTSD. Behav Modif. 2012 Nov;36(6):759-86. doi: 10.1177/0145445512441200. Epub 2012 Jun 5. Review.
PMID:22669968
Reference Type:Results Reference
Citation:Bormann JE, Liu L, Thorp SR, Lang AJ. Spiritual wellbeing mediates PTSD change in veterans with military-related PTSD. Int J Behav Med. 2012 Dec;19(4):496-502. doi: 10.1007/s12529-011-9186-1.
PMID:21874605
Reference Type:Reference
Citation: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.
PMID:18356284
Reference Type:Reference
Citation: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.
PMID:17518033
Reference Type:Reference
Citation: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.
PMID:16251489

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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