Pilot Trial of Mobile Mantram Delivery (mMRP)

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

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.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Mobile Mantram Repetition Program

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-directed MRP; Self-directed instruction in MRP via Internet	Behavioral: 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; Other Names: mMRP
Active Comparator: Supported MRP; Supported instruction in MRP via Internet	Behavioral: 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; Other Names: mMRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Abbreviated Client Satisfaction Questionnaire (CSQ-8)	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.	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	Day 28
PTSD Checklist for DSM-5 (PCL-5)	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.	Day 28
Patient Health Questionnaire Depression Items (PHQ-9)	Depression at post-treatment as measured by the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.	Day 28
Insomnia Severity Index	Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.	Day 28

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Ariel J. Lang, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Feasibility; Meditation; Internet-based care
• Other Study ID Numbers: IVX 23-001; SWIFT-IVI 22-115 (Other Grant/Funding Number: VA SWIFT IVI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No