Mantram Repetition to Manage PTSD in Veterans

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00120627
Collaborator
(none)
146
1
2
58
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mantram Repetition Program (MRP) plus Usual Care
  • Other: Usual care consisting of medication and case management
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
Study Start Date :
Nov 1, 2005
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Mantram + Usual Care

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.

Behavioral: Mantram Repetition Program (MRP) plus Usual Care
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.

Other: Usual care consisting of medication and case management
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.

Active Comparator: Arm 2: Usual Care alone

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

Other: Usual care consisting of medication and case management
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.

Outcome Measures

Primary Outcome Measures

  1. Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR [Pre-treatment and post-treatment]

    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.

  2. PTST Checklist (PCL) Civilian Version [Pre-treatment and Post-treatment]

    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

  1. Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score) [Pre-treatment and post-treatment]

    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.

  2. Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)] [Pre- & Post-Intervention]

    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.

  3. Mindfulness Attention Awareness Scale (MAAS) [Baseline, Post-Intervention]

    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.

  4. Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities [Pre- & Post-Intervention]

    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.

  5. Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization [Pre-treatment and Post-treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA San Diego Healthcare System, San Diego, CA San Diego California United States 92161

Sponsors and Collaborators

  • US Department of Veterans Affairs

Investigators

  • Principal Investigator: Jill E Bormann, PhD RN, VA San Diego Healthcare System, San Diego, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00120627
Other Study ID Numbers:
  • NRI 04-041
First Posted:
Jul 18, 2005
Last Update Posted:
Apr 28, 2015
Last Verified:
Aug 1, 2014

Study Results

Participant Flow

Recruitment Details Recruitment began in January 2006 and ended in December 2009. Participants were recruited from PTSD outpatient clinics and other primary care clinics in the VA system in southern California.
Pre-assignment Detail There were 4 subjects who dropped after random assignment and before entering the interventions. Two had scheduling conflicts and could not attend the groups at the time they were offered. One was too ill. The other did not have a reason.
Arm/Group Title Arm 1: Mantram + Usual Care Arm 2: Usual Care
Arm/Group Description The Mantram Repetition Program 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. Usual care consisting of medication and case-management. Usual care consisted of medication and case management: Case management consisted of provider meetings with Veterans at least once per month and monitoring medications, if prescribed.
Period Title: Overall Study
STARTED 71 75
Began Interventions 69 73
Did Not Complete Post-tx Assessments 3 3
COMPLETED 66 70
NOT COMPLETED 5 5

Baseline Characteristics

Arm/Group Title Treatment Arm: Mantram + Medication & Case Management Control Arm: Medication & Case Management Alone Total
Arm/Group Description Mantram Repetition Program (MRP) 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. The MRP includes three strategies for training attention and managing 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 were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states. Usual care consisting of medication and case-management. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed. Total of all reporting groups
Overall Participants 71 75 146
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
56
(10.31)
58
(9.86)
57
(10.10)
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
62
87.3%
64
85.3%
126
86.3%
>=65 years
9
12.7%
11
14.7%
20
13.7%
Sex: Female, Male (Count of Participants)
Female
3
4.2%
1
1.3%
4
2.7%
Male
68
95.8%
74
98.7%
142
97.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
20
28.2%
16
21.3%
36
24.7%
White
40
56.3%
45
60%
85
58.2%
More than one race
8
11.3%
6
8%
14
9.6%
Unknown or Not Reported
3
4.2%
8
10.7%
11
7.5%
Region of Enrollment (participants) [Number]
United States
71
100%
75
100%
146
100%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS for missing data; this is a maximum-likelihood method based on group assignment, demographic variables and clinical variables.
Arm/Group Title Arm 1: Mantram + Medication & Case Management (Usual Care) Arm 2: Medication & Case Management (Usual Care Alone)
Arm/Group Description The Mantram Repetition Program 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. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Baseline CAPS Scores
83.08
(16.17)
82.83
(19.44)
Post-treatment CAPS Scores
66.16
(23.58)
72.59
(24.97)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments 2 group (treatment vs. control) by 2 time (pre-intervention and post-intervention) one-way ANOVA
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments
Method ANOVA
Comments F (1,144) = 4.12, p < .05
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments
Method Fisher Exact
Comments
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing values; a maximum-likelihood method based on group assignment, demographic variables and clinical variables.
Arm/Group Title Arm 1: Mantram + Medication & Case Management (Usual Care) Arm 2: Medication & Case Management (Usual Care) Alone
Arm/Group 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. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Pre-treatment Mental Health Scores
33.15
(9.08)
32.89
(7.85)
Post-treatment Mental Health Scores
36.30
(8.94)
33.17
(7.58)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments
Method ANOVA
Comments
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.
Arm/Group Title Arm 1: Mantram + Medication & Case Management (Usual Care) Arm 2: Medication & Case Management (Usual Care) Alone
Arm/Group 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.. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Baseline Spiritual Wellbeing Score
22.30
(8.36)
20.59
(8.27)
Post-intervention Spiritual Wellbeing Score
26.72
(9.04)
20.04
(8.84)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments 2 group (treatment vs control) by 2 time points (pre-intervention and post-intervention)
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.0001
Comments
Method ANOVA
Comments
4. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Mantram + Meds & Case Management (Usual Care) Arm 2: Meds & Case Management (Usual Care Alone)
Arm/Group 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. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Baseline Mindfulness Attention Awareness
46.60
(13.40)
47.80
(12.02)
Post-Intervention Mindful Attention Awareness
50.99
(13.74)
46.04
(13.75)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method Mediation using Sobel Test
Comments
5. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS to replace missing data, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.
Arm/Group Title Arm 1: Mantram + Medication & Case Management (Usual Care) Arm 2: Medication & Case Management (Usual Care) Alone
Arm/Group Description The Mantram Repetition Program 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. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Baseline Quality of Life Enjoyment & Satisfaction
35.52
(9.28)
34.98
(9.22)
Post-intervention Quality of Life Enjoyment & Sati
39.34
(9.33)
35.75
(8.45)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.01
Comments
Method ANOVA
Comments
6. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
Intent to treat analysis using Expectation-Maximization (EM) algorithm in SPSS, a maximum-likelihood method based on group assignment, demographic variables and clinical variables.
Arm/Group Title Arm 1: Mantram + Medication & Case Management (Usual Care) Arm 2: Medication & Case Management (Usual Care) Alone
Arm/Group Description The Mantram Repetition Program 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. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Pre-treatment PCL
61.39
(11.62)
62.70
(10.40)
Post-treatment PCL
55.77
(14.30)
60.23
(12.17)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments 2 group (treatment vs control) by 2 time (pre-intervention and post-intervention) ANOVA
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.05
Comments
Method ANOVA
Comments
7. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Mantram + Usual Care Arm 2: Usual Care Alone
Arm/Group Description The Mantram Repetition Program 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. Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Pre-treatment Depression Subscale
12.52
(5.77)
12.32
(5.55)
Post-treatment Depression Subscale
10.60
(6.13)
12.24
(6.02)
Pre-treatment Anxiety Subscale
12.15
(5.56)
11.98
(5.55)
Post-treatment Anxiety Subscale
10.96
(5.63)
11.51
(5.46)
Pre-treatment Somatization Subscale
8.74
(4.99)
9.23
(5.40)
Post-treatment Somatization Subscale
7.66
(4.96)
8.44
(5.21)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments Depression Subscale
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANOVA
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments Anxiety Subscale
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value =0.31
Comments
Method ANOVA
Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments Somatization Subscale
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value =0.44
Comments
Method ANOVA
Comments
8. Post-Hoc Outcome
Title Re-experiencing (Criterion B) From the Clinician Administered PTSD Scale (CAPS) Clinician Administered PTSD Scale Defined by the Diagnostic and Statistical Manual, 4th Ed, Text Revision
Description Re-experiencing Subscale (Criterion B) assesses symptoms of persistent re-experiencing of the traumatic event. This may include recurrent, intrusive recollections of the traumatic event; recurring dreams of the event; acting or feeling as if the traumatic event were occuring; and intense psychological distress at exposure to internal or external cues that symbolize or represent the event. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.
Time Frame Pre-treatment to Post-treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Mantram + Usual Care Arm 2: Usual Care Alone
Arm/Group Description Mantram Repetition Program (MRP) for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. 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. Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Pre-treatment Re-experiencing Subscale
22.59
(6.67)
22.47
(7.20)
Post-treatment Re-experiencing Subscale
16.57
(8.58)
17.05
(8.84)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments Post-hoc analysis
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value =0.66
Comments
Method ANOVA
Comments
9. Post-Hoc Outcome
Title Avoidance (Criterion C) Subscale of the Clinician Administered PTSD Scale (CAPS) From Diagnostic and Statistical Manual, 4th Ed, Text Revision
Description Avoidance (Criterion C) Subscale assesses symptoms of feeling detached and estranged from others; markedly diminished interest in significant activities; efforts to avoid thoughts, feelings, or conversations associated with the trauma; and efforts to avoid activities, places, or people that arouse recollections of the trauma. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Score are summed for a total subscale score ranging from 0 to 56, higher scores indicating greater levels of symptoms.
Time Frame Pre-treatment and Post-treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Mantram + Usual Care Arm 2: Usual Care Alone
Arm/Group Description Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. 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. Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Pre-treatment Avoidance Subscale
32.99
(7.65)
33.73
(9.78)
Post-treatment Subscale
27.25
(12.12)
30.59
(12.83)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value = 0.18
Comments
Method ANOVA
Comments
10. Post-Hoc Outcome
Title Hyper-arousal (Criterion D) Subscale of CAPS From Diagnostic and Statistical Manual, 4th Ed., Text Revision
Description Hyper-arousal Subscale (Criterion D) assesses symptoms of difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hypervigilance, and exaggerated startle response. Items are rated by frequency on a scale of 0 (never) to 4 (daily or almost every day) and on intensity on a scale of 0 (none) to 4 (extreme, incapacitating distress). Scores are summed for a total subscale score ranging from 0 to 40, higher scores indicating greater levels of symptoms.
Time Frame Pre-treatment to Post-treatment

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Mantram + Usual Care Arm 2: Usual Care Alone
Arm/Group Description Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. 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. Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
Measure Participants 71 75
Pre-treatment Hyperarousal Subscale
27.56
(6.12)
27.39
(5.56)
Post-treatment Hyperarousal Subscale
23.37
(7.33)
25.27
(7.36)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram + Medication & Case Management (Usual Care), Arm 2: Medication & Case Management (Usual Care Alone)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.01
Comments
Method ANOVA
Comments

Adverse Events

Time Frame Entire study.
Adverse Event Reporting Description
Arm/Group Title Arm 1 Arm 2
Arm/Group Description he 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. Usual Care defined as receiving medication management and case management, as needed. Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed.
All Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Jill E. Bormann, PhD, RN, FAAN
Organization VA San Diego Healthcare System
Phone 858-552-8585 ext 2378
Email jill.bormann@va.gov
Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00120627
Other Study ID Numbers:
  • NRI 04-041
First Posted:
Jul 18, 2005
Last Update Posted:
Apr 28, 2015
Last Verified:
Aug 1, 2014