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OpenTrials
Completed

NCT Number: NCT05998967

Pilot Trial of Mobile Mantram Delivery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Mantram Repetition Program

Behavioral

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

Other names: mMRP

Primary outcomes

  1. Eligibility Rate

    Time frame: Day 0

    Rate of eligibility among those screened for participation

  2. Initiation Rate

    Time frame: Day 1

    Rate of intervention initiation among eligible Veterans

  3. Completion Rate

    Time frame: Day 28

    Rate of intervention completion among eligible Veterans

  4. 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)

  5. 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.

  6. 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.

  7. 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.

  8. 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

  1. Mantram Practice

    Time frame: Day 28

    Frequency of mantram practice in the past week as 0-7 days

  2. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 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.

  3. Patient Health Questionnaire Depression Items (PHQ-9)

    Time frame: 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.

  4. Insomnia Severity Index

    Time frame: Day 28

    Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: mMRP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2023
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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