Pilot Trial of Mobile Mantram Delivery

NCT ID: NCT05998967

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-09-30

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Self-directed MRP

Self-directed instruction in MRP via Internet

Group Type: EXPERIMENTAL

Mobile Mantram Repetition Program

Intervention Type: BEHAVIORAL

Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down

Supported MRP

Supported instruction in MRP via Internet

Group Type: ACTIVE_COMPARATOR

Mobile Mantram Repetition Program

Intervention Type: BEHAVIORAL

Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down

Interventions

Mobile Mantram Repetition Program

Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down

Intervention Type: BEHAVIORAL

Other Intervention Names

mMRP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ariel J. Lang, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

SWIFT-IVI 22-115

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IVX 23-001

Identifier Type: -

Identifier Source: org_study_id