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Pilot Trial of Mobile Mantram Delivery (mMRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05998967
Recruitment Status : Completed
First Posted : August 21, 2023
Results First Posted : March 21, 2024
Last Update Posted : March 21, 2024
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Mobile Mantram Repetition Program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Internet-based instruction in MRP in a self-directed or supported manner
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Acceptability of Mobile Mantram Repetition Program for Veterans With PTSD (IVI 22-115)
Actual Study Start Date : December 1, 2021
Actual Primary Completion Date : September 30, 2022
Actual Study Completion Date : September 30, 2022
Arms and Interventions
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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 Name: 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 Name: mMRP


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998967


Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Ariel J. Lang, PhD VA San Diego Healthcare System, San Diego, CA
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol and Statistical Analysis Plan  [PDF] August 12, 2021
Informed Consent Form  [PDF] May 18, 2023

More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT05998967    
Other Study ID Numbers: IVX 23-001
SWIFT-IVI 22-115 ( Other Grant/Funding Number: VA SWIFT IVI )
First Posted: August 21, 2023    Key Record Dates
Results First Posted: March 21, 2024
Last Update Posted: March 21, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Internet-based care
Meditation
Feasibility