Pilot Trial of Mobile Mantram Delivery

PTSD Clinical Trial

— mMRP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05998967
• Other study ID #: IVX 23-001
• Secondary ID: SWIFT-IVI 22-115
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

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

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eligibility Rate	Rate of eligibility among those screened for participation	Day 0
Primary	Initiation Rate	Rate of intervention initiation among eligible Veterans	Day 1
Primary	Completion Rate	Rate of intervention completion among eligible Veterans	Day 28
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Mantram Practice	Frequency of mantram practice in the past week as 0-7 days	Day 28
Secondary	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
Secondary	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
Secondary	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