Pilot Trial of Mobile Mantram Delivery

Study Overview
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Brief Summary
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Mantram Repetition Program (MRP) is a meditation practice that involves silent repetition of a spiritual word, one-pointed attention, and slowing down. It has been shown to help reduce PTSD symptoms among Veterans. This study will look at how Veterans reach to learning MRP via the Internet, either in a self-directed way or with text/phone support.

Detailed Description
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Easily accessible interventions to address post-traumatic stress disorder (PTSD) can play critical role in reducing PTSD and associated symptoms in Veterans, especially for those who remain symptomatic after treatment with other evidence-based interventions, those who prefer complimentary and integrative therapies, or those who have difficulty accessing traditional face-to-face mental health services. The value of these programs is their ability to provide Veterans with more options in their recovery journey and to reach a broad range of Veterans across multiple settings, including remote rural contexts. The Mantram Repetition Program (MRP) is a meditation-based practice that consists of the repetition of a spiritual word, one-pointed attention, and slowing down. MRP has been shown to reduce stress in several high-risk populations, and two large randomized, controlled studies show that MRP reduces PTSD symptoms among Veterans. A brief, web-based, self-directed version of MRP has been developed to increase the accessibility of evidence-based PTSD treatment. This version of MRP was tested in a pilot study with undergraduate students, demonstrating its ease of use and success in getting students to engage with the practice. The proposed mixed method study will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to evaluate the mobile MRP in Veterans with PTSD in two conditions: self-directed and with text/phone support. Data from this pilot study will inform the refinement of the MRP delivery strategy and the development of a full-scale trial to test its effectiveness and implementation outcomes, as well as barriers and facilitators, and other contextual factors.

Official Title
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Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Mobile Mantram Repetition Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran Primary clinical complaint of PTSD Access to an Internet-enabled device Exclusion Criteria: Cognitive impairment or mental health concerns that necessitated a higher level of care or interfered with ability to engage in study activities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Internet-based instruction in MRP in a self-directed or supported manner
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-directed MRP<br>Self-directed instruction in MRP via Internet | Behavioral: Mobile Mantram Repetition Program<br>* Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down<br>* Other names: mMRP;|
| Active Comparator: Supported MRP<br>Supported instruction in MRP via Internet | Behavioral: Mobile Mantram Repetition Program<br>* Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down<br>* Other names: mMRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility rate | Rate of eligibility among those screened for participation | Day 0 | 
| Initiation rate | Rate of intervention initiation among eligible Veterans | Day 1 | 
| Completion rate | Rate of intervention completion among eligible Veterans | Day 28 | 
| Credibility | Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very) | Day 1 | 
| Client Satisfaction Questionnaire (CSQ-8) | Degree of satisfaction with care received as measured by a CSQ-8 total score. Scores range from 8-32 with higher scores indicating greater satisfaction. | Day 28 | 
| Acceptability of Intervention Measure (AIM) | Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability. | Day 28 | 
| Intervention Appropriateness Measure (IAM) | Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness. | Day 28 | 
| Feasibility of Intervention Measure (FIM) | Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mantram practice | Frequency of mantram practice in the past week as 0-7 days | Weeks 2-4 | 
| PTSD Checklist for DSM-5 (PCL-5) | Change in PTSD symptoms from baseline to post-treatment as measured by change in the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms. | Day 0-28 | 
| Patient Health Questionnaire depression items (PHQ-9) | Change in depression from baseline to post-treatment as measured by change in the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression. | Day 0-28 | 
| Insomnia Severity Index | Change in insomnia from baseline to post-treatment as measured by change in the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia. | Day 0-28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Internet-based care, Meditation, Feasibility