Clinical trial NCT05998967: Pilot Trial of Mobile Mantram Delivery
Official title: Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Internet-based care
Meditation
Feasibility
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Internet-based instruction in MRP in a self-directed or supported manner
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Eligibility Rate
timeFrame: Day 0
measure: Initiation Rate
timeFrame: Day 1
measure: Completion Rate
timeFrame: Day 28
measure: Credibility
timeFrame: Day 1
measure: Abbreviated Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Day 28
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Day 28
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Day 28
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Day 28
Secondary outcomes:
measure: Mantram Practice
timeFrame: Day 28
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Day 28
measure: Patient Health Questionnaire Depression Items (PHQ-9)
timeFrame: Day 28
measure: Insomnia Severity Index
timeFrame: Day 28
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Ariel J. Lang, PhD
role: PRINCIPAL_INVESTIGATOR
References: