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| ID | Type | Description | Link |
|---|---|---|---|
| SWIFT-IVI 22-115 | Other Grant/Funding Number | VA SWIFT IVI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-directed MRP | Experimental | Self-directed instruction in MRP via Internet |
|
| Supported MRP | Active Comparator | Supported instruction in MRP via Internet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel J. Lang, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
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Participants had a primary clinical complaint of PTSD and an Internet-enabled device
Recruited between December 2021 and August 2022 based on clinical referrals and lists of potential research participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-directed MRP | Self-directed instruction in MRP via Internet 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 |
| FG001 | Supported MRP | Supported instruction in MRP via Internet 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-directed Mantram Repetition Program (MRP) | Self-directed instruction in MRP via Internet 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 |
| BG001 | Supported Mantram Repetition Program (MRP) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eligibility Rate | Rate of eligibility among those screened for participation | Screened individuals | Posted | Count of Participants | Participants | Day 0 |
|
|
4 week study period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self-directed MRP | Self-directed instruction in MRP via Internet 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emotional distress | Psychiatric disorders | Systematic Assessment | Distress related to assessment of mental health symptoms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariel J Lang, PhD, MPH | VA San Diego HCS | (858) 552-8585 | ariel.lang@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2021 | Mar 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 18, 2023 | Aug 7, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Internet-based instruction in MRP in a self-directed or supported manner
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|
| 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 |
| 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 |
Supported instruction in MRP via Internet 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| PTSD Checklist for DSM-5 (PCL-5) | Scores range from 0-80 with higher scores indicating greater PTSD symptoms. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire depression (PHQ-9) | Scores range from 0-27 with higher scores indicating greater depression. | Mean | Standard Deviation | units on a scale |
|
| Insomnia Severity Index (ISI) | Scores range from 0-28 with higher scores indicating greater insomnia. | Mean | Standard Deviation | units on a scale |
|
|
| Primary | Initiation Rate | Rate of intervention initiation among eligible Veterans | Eligible individuals | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Primary | Completion Rate | Rate of intervention completion among eligible Veterans | Posted | Count of Participants | Participants | 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) | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 28 |
|
|
|
| Secondary | Mantram Practice | Frequency of mantram practice in the past week as 0-7 days | Posted | Mean | Standard Deviation | days/week | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 28 |
|
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|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Supported MRP | Supported instruction in MRP via Internet 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 | 0 | 19 | 0 | 19 | 1 | 19 |
|
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