Mantram Repetition Meditation for Veterans With PTSD

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego, California, and Bedford, Massachusetts.

Detailed Description
-----------------
The investigators conducted a prospective, parallel group, two-site, randomized clinical trial on the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control condition of Present Centered Therapy (PCT) in a diverse sample of Veterans with post-traumatic stress disorder (PTSD). Primary outcomes included clinician-assessed and self-reported PTSD symptom severity. Secondary outcomes included insomnia, depression, anger, spiritual well-being, and mindfulness. Veterans were were recruited from a variety of clinics, including primary care, women's health, and specialty clinics in two geographical locations within the Department of Veterans Affairs healthcare system.

Official Title
-----------------
Portable Mantram Meditation for Veterans With Military Related PTSD

Conditions
-----------------
Stress Disorders, Post-Traumatic

Intervention / Treatment
-----------------
* Behavioral: Mantram Repetition Program (MRP)
* Behavioral: Present Centered Therapy (PCT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Read and write English fluently Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma Transportation to attend meetings and available to complete study protocols Stable dose and type of PTSD medications for at least 6 weeks (per chart review) Willing to track medication changes during study Exclusion Criteria: Inability to give informed, voluntary consent Cognitive impairment sufficient to cause inability to complete the protocol Psychotic symptoms Dementia or other organic mental disorders that may cause inability to complete the protocol Significant documented alcohol/substance abuse Presence of severe suicidal urges or intent Residence in a geographical area outside of San Diego County or Bedford, Massachusetts area Current daily practice of any skills of any meditation-based program - including, but not limited to: Transcendental Meditation (TM) Yoga Tai Chi Qi-Gong Vipassana or Insight Meditation Loving-Kindness or Compassion Meditation Mindfulness-Based Stress Reduction (MBSR) or other mindfulness program Guided Imagery Mantram Repetition Passage Meditation Walking Meditation Zen or Buddhist meditation Self-hypnosis, Bio-feedback, etc. Other participant circumstances that, in the opinion of a consensus of the study team, would interfere with the safety of prospective participants or their need for treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mantram Repetition Program (MRP)<br>A portable meditation-based Mantram Repetition Program (MRP) will be delivered individually in 8-weekly 1 hour sessions to teach a set of strategies for training attention to manage symptoms. For this study, the program targets symptoms of posttraumatic stress disorder (PTSD) in Veterans who have experienced military-related trauma. | Behavioral: Mantram Repetition Program (MRP)<br>* 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.<br>* Other names: MRP, Mantram Meditation;|
| Active Comparator: Present Centered Therapy (PCT)<br>Present Centered Therapy (PCT) is a form of individually-delivered 8-weekly, 1 hour sessions that are problem-oriented to improve current coping. For this study, it served as an attention control arm for the non-specific effects of individual therapist interaction. | Behavioral: Present Centered Therapy (PCT)<br>* 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. 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.<br>* Other names: PCT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV) | 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. | Baseline to post-treatment (week 8); Baseline to 2 months post-treatment. | 
| Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS) | 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. | Baseline to post-treatment (week 8); Baseline to 2 months post-treatment. | 
| Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS) | 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. | Baseline to post-treatment (week 8); Baseline to 2 months post-treatment. | 
| Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS) | 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. | Baseline to post-treatment (week 8); baseline to 2 months post-treatment. | 
| PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version] | 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. | Baseline to post-treatment (week 8); Baseline to 2-months post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | 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. | Baseline to post-treatment (week 8); baseline to 2 months post-treatment. | 
| Patient Health Questionnaire (PHQ-9) for Depression | 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. | Baseline to post-treatment (week 8); Baseline to 2-months post-treatment. | 
| Spielberger State Anger Inventory-Short Form | 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. | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. | 
| Spielberger Trait Anger Inventory-Short Form | 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. | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. | 
| Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx) | 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. | Baseline to post-treatment (week 8); baseline to 2-months post-treatment. | 
| Five Facet Mindfulness Questionnaire (FFMQ) | 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. | Baseline to post-treatment (week 8); baseline to 2-months follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complementary Therapy, Stress Disorders, Post-Traumatic, Veterans Health, Clinical Trials, Randomized, Mindfulness, Spirituality, Meditation, Mind-body therapy