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Mantram Repetition Meditation for Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT01506323
Recruitment Status : Completed
First Posted : January 10, 2012
Results First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stress Disorders, Post-Traumatic
Interventions Behavioral: Mantram Repetition Program (MRP)
Behavioral: Present Centered Therapy (PCT)
Enrollment 181
Recruitment Details Veterans with a history of military-related posttraumatic stress disorder (PTSD) were recruited from January 2012 to March 2014 from outpatient clinics and primary care providers at the VA San Diego Healthcare System in San Diego, CA, and the Edith Nourse Rogers Memorial VA Hospital in Bedford, MA.
Pre-assignment Details

Five (5) enrolled participants were excluded from the trial before assignment to groups due to:

1) lost to follow-up; 2) could not commit to the study; 3) transportation difficulties. Three (3) participants were missing significant demographic data, resulting in a total of 173 for the analysis.

Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning. The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
Period Title: Overall Study
Started 89 84
Post-treatment Completers 69 72
Post-treatment Completed CAPS 68 72
Completed 65 71
Not Completed 24 13
Reason Not Completed
Lost to Follow-up             5             4
Withdrawal by Subject             4             4
Lack of Efficacy             1             3
Moved out of area             5             2
Schedule or Transportation conflict             8             0
Started another treatment             1             0
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT) Total
Hide Arm/Group Description The Mantram Repetition Program (MRP) teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning. Present Centered Individual Therapy (PCT): The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Total of all reporting groups
Overall Number of Baseline Participants 89 84 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 84 participants 173 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
74
  83.1%
70
  83.3%
144
  83.2%
>=65 years
15
  16.9%
14
  16.7%
29
  16.8%
[1]
Measure Description: Baseline data was collected from participants who scored greater or equal to 50 on the PTSD Checklist-Military (PCL-M) and greater or equal to 45 on the Clinician Administered PTSD Scale (CAPS).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 84 participants 173 participants
Female
16
  18.0%
10
  11.9%
26
  15.0%
Male
73
  82.0%
74
  88.1%
147
  85.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 84 participants 173 participants
Hispanic or Latino
13
  14.6%
17
  20.2%
30
  17.3%
Not Hispanic or Latino
76
  85.4%
67
  79.8%
143
  82.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 84 participants 173 participants
American Indian or Alaska Native
2
   2.2%
4
   4.8%
6
   3.5%
Asian
4
   4.5%
2
   2.4%
6
   3.5%
Native Hawaiian or Other Pacific Islander
14
  15.7%
11
  13.1%
25
  14.5%
Black or African American
1
   1.1%
6
   7.1%
7
   4.0%
White
60
  67.4%
51
  60.7%
111
  64.2%
More than one race
8
   9.0%
10
  11.9%
18
  10.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 84 participants 173 participants
89 84 173
1.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)
Hide Description PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.
Time Frame Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 77.46  (16.48) 75.61  (16.83)
Post-treatment 52.39  (22.60) 62.07  (23.42)
2 months follow-up 50.62  (23.21) 59.00  (22.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline (week 0) to post-treatment (week 8). Cronbach's alpha for this study was .92 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.006
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments Mixed-effects, repeated measures models adjusting for demographic factors were implemented.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline (week 0) to 2 months follow-up.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.031
Comments The p-value was adjusted for multiple comparisons using false discovery rate.
Method Mixed Models Analysis
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
2.Primary Outcome
Title Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)
Hide Description This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.
Time Frame Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 20.74  (7.63) 21.80  (6.42)
Post-treatment 14.40  (8.71) 15.78  (9.12)
2-months follow-up 14.32  (8.73) 15.94  (8.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .86 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments The p-value is based on false discovery rate adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2 months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
3.Primary Outcome
Title Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)
Hide Description This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.
Time Frame Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 87 81
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 29.92  (8.29) 29.13  (8.87)
Post-treatment 19.91  (10.50) 24.13  (11.18)
2-months follow-up 18.67  (11.61) 21.78  (10.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .85 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.008
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method repeated measures
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2 months post-treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.09
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
4.Primary Outcome
Title Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)
Hide Description This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.
Time Frame Baseline to post-treatment (week 8); baseline to 2 months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)`
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 25.01  (5.76) 24.64  (5.64)
Post-treatment 18.01  (8.75) 21.70  (6.53)
2 months post-treatment 17.61  (8.18) 21.01  (6.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)`
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .78 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.006
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)`
Comments This analysis is from baseline to 2 months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.03
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method repeated measures
Comments [Not Specified]
5.Primary Outcome
Title PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]
Hide Description PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of > 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.
Time Frame Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 59.23  (12.09) 57.57  (11.56)
Post-treatment 45.32  (15.27) 50.20  (13.92)
2-months Post-treatment 44.74  (14.58) 48.42  (14.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis was from baseline to post-treatment. Cronbach's alpha for this study was .92 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.04
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2-months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.25
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide Description ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale with higher scores meaning greater insomnia. Total scores range from 0-28. Original results were interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia and 21-28 = severe clinical insomnia. Later recommendations for a clinical, not community sample, are a cut-off of 11 points.
Time Frame Baseline to post-treatment (week 8); baseline to 2 months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 18.33  (6.59) 16.34  (6.59)
Post-treatment 14.22  (7.47) 16.62  (6.57)
2 months post-treatment 12.73  (7.90) 15.92  (6.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0008
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method repeated measures
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy
Comments This analysis is from baseline to 2 months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.006
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Patient Health Questionnaire (PHQ-9) for Depression
Hide Description PHQ-9 is a 9-item depression screening tool based on the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and total scores range from 0 to 27. Higher scores indicate worse depression. A score of 11 or more considered probable depression and 20 or more is considered severe depression. It is well-validated and widely-used in medical settings such as primary care. The PHQ-9 includes the two major symptom domains characteristic of depression: affective and somatic symptoms.
Time Frame Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 15.42  (5.89) 15.15  (5.56)
Post-treatment 10.68  (6.19) 12.81  (5.38)
2 months post-treatment 10.57  (6.37) 12.18  (6.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for total score in this study was .86 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.10
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing. Raw p-value was <0.02.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.49
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Spielberger State Anger Inventory-Short Form
Hide Description Spielberger State Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale to measure anger as an emotional state. Scores range from 10 to 40 with higher scores indicating more anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.
Time Frame Baseline to post-treatment (week 8); baseline to 2-months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Arm 1: Mantram Repetition Program (MRP) Arm 2: Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 23.43  (9.78) 12.00  (10.19)
Post-treatment 21.21  (8.58) 22.20  (10.08)
2 months post-treatment 21.22  (9.18) 21.27  (8.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram Repetition Program (MRP), Arm 2: Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .96 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.78
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram Repetition Program (MRP), Arm 2: Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2-months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.99
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Spielberger Trait Anger Inventory-Short Form
Hide Description Spielberger Trait Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale used to measure anger as a personality trait. Scores range from 10 to 40 with higher scores indicating more trait anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.
Time Frame Baseline to post-treatment (week 8); baseline to 2-months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Arm 1: Mantram Repetition Program (MRP) Arm 2: Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.34  (7.16) 21.89  (6.07)
Post-treatment 20.90  (6.95) 10.37  (6.23)
2-months post-treatment 19.53  (6.81) 18.62  (5.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram Repetition Program (MRP), Arm 2: Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .89 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.99
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram Repetition Program (MRP), Arm 2: Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2-months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.94
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)
Hide Description The FACIT-SpEx was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Total scores range from 0 to 92. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.
Time Frame Baseline to post-treatment (week 8); baseline to 2-months post-treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 43.69  (17.84) 44.74  (19.39)
Post-treatment 50.41  (17.24) 46.28  (16.47)
2 months Post-treatment 50.95  (18.26) 47.80  (19.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for this study was .88 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.12
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2-months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.49
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Five Facet Mindfulness Questionnaire (FFMQ)
Hide Description FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. Each subscale contains either 7 or 8 items that are rated on a 1 (never or very rarely true) to 5 (very often or always true) Likert scale. Items are randomly reversed scored and higher scores represent greater levels of mindfulness. Total scores range from 39 to 195.
Time Frame Baseline to post-treatment (week 8); baseline to 2-months follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.
Arm/Group Title Arm 1: Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description:
The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
Overall Number of Participants Analyzed 89 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 121.34  (20.30) 118.39  (17.33)
Post-treatment 121.29  (20.64) 116.75  (19.56)
2 months Post-treatment 120.43  (21.40) 119.00  (19.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to post-treatment. Cronbach's alpha for total score was .89 at baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.59
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Mantram Repetition Program (MRP), Present Centered Therapy (PCT)
Comments This analysis is from baseline to 2-months post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.10
Comments This p-value is based on a false discovery rate adjustment for multiple hypothesis testing.
Method Mixed Models Analysis
Comments Mixed-effects, repeated measures models adjusting for demographic factors were implemented.
Time Frame For 2 years of the study during active recruitment, enrollment, and study participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Hide Arm/Group Description The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning. The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
All-Cause Mortality
Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/89 (1.12%)      3/84 (3.57%)    
Psychiatric disorders     
Psychosis * [1]  1/89 (1.12%)  1 0/84 (0.00%)  0
Hospitalization for detoxification * [2]  0/89 (0.00%)  0 1/84 (1.19%)  1
Hospitalization for detoxification. * [3]  0/89 (0.00%)  0 1/84 (1.19%)  1
Hospitalization for detoxification. * [4]  0/89 (0.00%)  0 1/84 (1.19%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant ran out of his prescription meds to treat depression. He went to the emergency room and was admitted to the hospital with a diagnosis of Depression Psychosis-Unspecified. He withdrew from the study.
[2]
Participant was enrolled in study as clean and sober but relapsed. He was admitted to in-patient detoxification for substance abuse and follow-up after care. He remained in the research study.
[3]
Participant met study criteria upon enrollment, but had a relapse of substance abuse and was admitted to hospital for treatment. After detoxification, participant continued in the study.
[4]
Participant started using alcohol after 4 months of sobriety. He sought inpatient treatment and completed detoxification with follow-up. Participant remained in the study.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mantram Repetition Program (MRP) Present Centered Therapy (PCT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/89 (0.00%)      0/84 (0.00%)    
Study was to provide interventions for both conditions (MRP and PCT) in "group" format. Due to poor recruitment and after approval from Data Monitoring Committee, the study protocol was changed to provide both interventions in "individual" format.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jill E. Bormann
Organization: VA San Diego Healthcare System
Phone: 858-552-8585 ext x2378
Publications of Results:
Bormann JE, Plumb DN, Beck DJ, Glickman M, Zhao S, Osei-Bonsu PE, Johnston JM, Herz L, Elwy AR. Portable meditation-based mantram program reduces PTSD symptoms in veterans: A randomized controlled trial. Poster session presented at: International Society for Traumatic Stress Studies Annual Symposium; 2014 Nov 1; Miami, FL.
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01506323     History of Changes
Other Study ID Numbers: SPLE-003-11S
First Submitted: December 19, 2011
First Posted: January 10, 2012
Results First Submitted: July 8, 2015
Results First Posted: September 2, 2015
Last Update Posted: September 2, 2015