Pilot Trial of Mobile Mantram Delivery

Not Applicable

Completed

Conditions: PTSD

Interventions: Behavioral: Mobile Mantram Repetition Program

Registration Number: NCT05998967

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supported MRP	Mobile Mantram Repetition Program	Supported instruction in MRP via Internet
Self-directed MRP	Mobile Mantram Repetition Program	Self-directed instruction in MRP via Internet

Primary Outcome Measures

Name	Time	Method
Eligibility Rate	Day 0	Rate of eligibility among those screened for participation
Acceptability of Intervention Measure (AIM)	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	Day 1	Rate of intervention initiation among eligible Veterans
Completion Rate	Day 28	Rate of intervention completion among eligible Veterans
Credibility	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)	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)	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)	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 Outcome Measures

Name	Time	Method
Mantram Practice	Day 28	Frequency of mantram practice in the past week as 0-7 days
PTSD Checklist for DSM-5 (PCL-5)	Day 28	PTSD symptoms at post-treatment as measured by the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms.
Patient Health Questionnaire Depression Items (PHQ-9)	Day 28	Depression at post-treatment as measured by the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.
Insomnia Severity Index	Day 28	Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.