Trial Outcomes & Findings for Mantram Repetition Meditation for Veterans With PTSD (NCT NCT01506323)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

181 participants

Primary outcome timeframe

Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

Results posted on

2015-09-02

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Mantram Repetition Program (MRP) 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.	Present Centered Therapy (PCT) 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.
Overall Study STARTED	89	84
Overall Study Post-treatment Completers	69	72
Overall Study Post-treatment Completed CAPS	68	72
Overall Study COMPLETED	65	71
Overall Study NOT COMPLETED	24	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Mantram Repetition Program (MRP) 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.	Present Centered Therapy (PCT) 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.
Overall Study Lost to Follow-up	5	4
Overall Study Withdrawal by Subject	4	4
Overall Study Lack of Efficacy	1	3
Overall Study Moved out of area	5	2
Overall Study Schedule or Transportation conflict	8	0
Overall Study Started another treatment	1	0

Baseline Characteristics

Mantram Repetition Meditation for Veterans With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mantram Repetition Program (MRP) n=89 Participants 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 Therapy (PCT) n=84 Participants 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 n=173 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	74 Participants n=5 Participants	70 Participants n=7 Participants	144 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	74 Participants n=7 Participants	147 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants	67 Participants n=7 Participants	143 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants	51 Participants n=7 Participants	111 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	84 participants n=7 Participants	173 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mantram Repetition Program (MRP) n=89 Participants 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.	Present Centered Therapy (PCT) n=84 Participants 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.
Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) Baseline	77.46 units on a scale Standard Deviation 16.48	75.61 units on a scale Standard Deviation 16.83
Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) Post-treatment	52.39 units on a scale Standard Deviation 22.60	62.07 units on a scale Standard Deviation 23.42
Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) 2 months follow-up	50.62 units on a scale Standard Deviation 23.21	59.00 units on a scale Standard Deviation 22.79

PRIMARY outcome

Timeframe: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mantram Repetition Program (MRP) n=89 Participants 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.	Present Centered Therapy (PCT) n=84 Participants 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.
Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) Baseline	20.74 units on a scale Standard Deviation 7.63	21.80 units on a scale Standard Deviation 6.42
Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) Post-treatment	14.40 units on a scale Standard Deviation 8.71	15.78 units on a scale Standard Deviation 9.12
Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) 2-months follow-up	14.32 units on a scale Standard Deviation 8.73	15.94 units on a scale Standard Deviation 8.99

PRIMARY outcome

Timeframe: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mantram Repetition Program (MRP) n=87 Participants 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.	Present Centered Therapy (PCT) n=81 Participants 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.
Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) Baseline	29.92 units on a scale Standard Deviation 8.29	29.13 units on a scale Standard Deviation 8.87
Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) Post-treatment	19.91 units on a scale Standard Deviation 10.50	24.13 units on a scale Standard Deviation 11.18
Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) 2-months follow-up	18.67 units on a scale Standard Deviation 11.61	21.78 units on a scale Standard Deviation 10.90

PRIMARY outcome

Timeframe: Baseline to post-treatment (week 8); baseline to 2 months post-treatment.

Population: 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.

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.