Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Eligibility Rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
Self-directed MRP
Self-directed instruction in MRP via Internet
Intervention: Mobile Mantram Repetition Program (Behavioral)
Supported MRP
Supported instruction in MRP via Internet
Intervention: Mobile Mantram Repetition Program (Behavioral)
Outcomes
Primary Outcomes
Eligibility Rate
Time Frame: Day 0
Rate of eligibility among those screened for participation
Acceptability of Intervention Measure (AIM)
Time Frame: Day 28
Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.
Initiation Rate
Time Frame: Day 1
Rate of intervention initiation among eligible Veterans
Completion Rate
Time Frame: Day 28
Rate of intervention completion among eligible Veterans
Credibility
Time Frame: Day 1
Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)
Abbreviated Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Day 28
Degree of satisfaction with care received as measured by 4 items from the CSQ-8, creating a 4-item total score. Scores range from 4-16 with higher scores indicating greater satisfaction.
Intervention Appropriateness Measure (IAM)
Time Frame: Day 28
Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.
Feasibility of Intervention Measure (FIM)
Time Frame: Day 28
Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.
Secondary Outcomes
- Mantram Practice(Day 28)
- PTSD Checklist for DSM-5 (PCL-5)(Day 28)
- Patient Health Questionnaire Depression Items (PHQ-9)(Day 28)
- Insomnia Severity Index(Day 28)