NCT05998967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

March 21, 2024

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

August 7, 2023

Results QC Date

August 24, 2023

Last Update Submit

March 19, 2024

Conditions

PTSD

Keywords

Internet-based careMeditationFeasibility

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (4)

  • Mantram Practice

    Day 28

  • PTSD Checklist for DSM-5 (PCL-5)

    Day 28

  • Patient Health Questionnaire Depression Items (PHQ-9)

    Day 28

  • Insomnia Severity Index

    Day 28

Study Arms (2)

Self-directed MRP

EXPERIMENTAL

Self-directed instruction in MRP via Internet

Behavioral: Mobile Mantram Repetition Program

Supported MRP

ACTIVE COMPARATOR

Supported instruction in MRP via Internet

Behavioral: Mobile Mantram Repetition Program

Interventions

Mobile Mantram Repetition ProgramBEHAVIORAL

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

Also known as: mMRP
Self-directed MRPSupported MRP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • Primary clinical complaint of PTSD
  • Access to an Internet-enabled device

You may not qualify if:

  • Cognitive impairment or mental health concerns that necessitated a higher level of care or interfered with ability to engage in study activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Ariel J Lang, PhD, MPH
Organization
VA San Diego HCS
ariel.lang@va.gov
(858) 552-8585

Study Officials

  • Ariel J. Lang, PhD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Internet-based instruction in MRP in a self-directed or supported manner
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 21, 2023

Study Start

December 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

March 21, 2024

Results First Posted

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)