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Mantram Repetition to Manage PTSD in Veterans

Primary Purpose

Stress Disorders, Post Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mantram Repetition Program (MRP) plus Usual Care
Usual care consisting of medication and case management
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post Traumatic focused on measuring Randomized Controlled Trial, Intervention Study, Mindfulness, Complementary Therapy, Mind-Body Relations (Metaphysics), Spiritual Therapy, Meditation, Qualitative Analysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Mantram + Usual Care

Arm 2: Usual Care alone

Arm 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.

Usual care alone is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.

Outcomes

Primary Outcome Measures

Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
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.
PTST Checklist (PCL) Civilian Version
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.

Secondary Outcome Measures

Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
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.
Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
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.
Mindfulness Attention Awareness Scale (MAAS)
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.
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
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.
Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
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.

Full Information

First Posted
July 12, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00120627
Brief Title
Mantram Repetition to Manage PTSD in Veterans
Official Title
Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post Traumatic
Keywords
Randomized Controlled Trial, Intervention Study, Mindfulness, Complementary Therapy, Mind-Body Relations (Metaphysics), Spiritual Therapy, Meditation, Qualitative Analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Mantram + Usual Care
Arm Type
Experimental
Arm 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.
Arm Title
Arm 2: Usual Care alone
Arm Type
Active Comparator
Arm Description
Usual care alone is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.
Intervention Type
Behavioral
Intervention Name(s)
Mantram Repetition Program (MRP) plus Usual Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care consisting of medication and case management
Intervention Description
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
Primary Outcome Measure Information:
Title
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
Description
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
Title
PTST Checklist (PCL) Civilian Version
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. 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
Secondary Outcome Measure Information:
Title
Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
Description
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-treatment and post-treatment
Title
Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
Description
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
Pre- & Post-Intervention
Title
Mindfulness Attention Awareness Scale (MAAS)
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. 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
Baseline, Post-Intervention
Title
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
Description
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- & Post-Intervention
Title
Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
Description
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.
Time Frame
Pre-treatment and Post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill E Bormann, PhD RN
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Bormann JE. Frequent, Silent Mantram Repetition: A Jacuzzi for the Mind. Topics in Emergency Medicine. 2005 Apr 1; 27(2):163-166.
Results Reference
background
PubMed Identifier
18356284
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. doi: 10.1177/0898010107311276. Epub 2008 Mar 20.
Results Reference
background
PubMed Identifier
17518033
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. doi: 10.1111/j.1945-1474.2007.tb00175.x.
Results Reference
background
PubMed Identifier
16251489
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. doi: 10.1177/0898010105278929.
Results Reference
background
Citation
Bormann JE, Hurst S, Thorp SR, Glaser D. Spiritually-Based Mantram Repetition to Manage PTSD in Veterans: A Qualitative Analysis of Use and Outcomes. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2010 Apr 1; 39(Suppl 1):216.
Results Reference
result
PubMed Identifier
21874605
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. Erratum In: Int J Behav Med. 2012 Jun;19(2):241.
Results Reference
result
Citation
Bormann JE. Spiritual well-being and PTSD symptoms in veterans: A predictive model. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2009 Dec 1; Suppl:114.
Results Reference
result
PubMed Identifier
24203540
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.
Results Reference
result
PubMed Identifier
22669968
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.
Results Reference
result
Citation
Bormann JE, Thorp SR, Wetherell JL, Golshan S, Lang AJ. Meditation-Based Mantram Intervention for Veterans with Posttraumatic Stress Disorder: A Randomized Trial. Psychological trauma : theory, research, practice and policy. 2013 Jan 1; 5(3):259-267.
Results Reference
result
PubMed Identifier
25397817
Citation
Bormann JE, Oman D, Walter KH, Johnson BD. Mindful attention increases and mediates psychological outcomes following mantram repetition practice in veterans with posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S13-8. doi: 10.1097/MLR.0000000000000200.
Results Reference
derived

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Mantram Repetition to Manage PTSD in Veterans

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