PTSD
Conditions
Keywords
Internet-based care, Meditation, Feasibility
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.
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.
Interventions
BEHAVIORALMobile Mantram Repetition Program
Internet-based instruction in a meditation practice that involves silent repetition of a spiritual word, one-pointed attention and slowing down
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Internet-based instruction in MRP in a self-directed or supported manner
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | 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. |
| Credibility | 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) |
| Abbreviated Client Satisfaction Questionnaire (CSQ-8) | 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. |
| Acceptability of Intervention Measure (AIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
| Eligibility Rate | Day 0 | Rate of eligibility among those screened for participation |
| Initiation Rate | Day 1 | Rate of intervention initiation among eligible Veterans |
| Completion Rate | Day 28 | Rate of intervention completion among eligible Veterans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | 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. |
| Patient Health Questionnaire Depression Items (PHQ-9) | 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. |
| Insomnia Severity Index | Day 28 | Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia. |
| Mantram Practice | Day 28 | Frequency of mantram practice in the past week as 0-7 days |
Countries
United States
Participant flow
Recruitment details
Recruited between December 2021 and August 2022 based on clinical referrals and lists of potential research participants
Pre-assignment details
Participants had a primary clinical complaint of PTSD and an Internet-enabled device
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| Supported Mantram Repetition Program (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 | 19 |
| Total | 36 |
Baseline characteristics
| Characteristic | Self-directed Mantram Repetition Program (MRP) | Supported Mantram Repetition Program (MRP) | Total |
|---|---|---|---|
| Age, Continuous | 51.29 years STANDARD_DEVIATION 16.87 | 49.79 years STANDARD_DEVIATION 14.52 | 50.50 years STANDARD_DEVIATION 15.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 14 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Insomnia Severity Index (ISI) | 15.94 units on a scale STANDARD_DEVIATION 6.55 | 13.00 units on a scale STANDARD_DEVIATION 8.13 | 14.39 units on a scale STANDARD_DEVIATION 7.47 |
| Patient Health Questionnaire depression (PHQ-9) | 11.47 units on a scale STANDARD_DEVIATION 6.32 | 10.58 units on a scale STANDARD_DEVIATION 5.58 | 11.00 units on a scale STANDARD_DEVIATION 5.87 |
| PTSD Checklist for DSM-5 (PCL-5) | 35.94 units on a scale STANDARD_DEVIATION 18.28 | 30.56 units on a scale STANDARD_DEVIATION 16.73 | 33.17 units on a scale STANDARD_DEVIATION 17.46 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 10 Participants | 11 Participants | 21 Participants |
| Region of Enrollment Vanuatu | 17 participants | 19 participants | 36 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 19 |
| other Total, other adverse events | 0 / 17 | 1 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 19 |
Outcome results
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Abbreviated Client Satisfaction Questionnaire (CSQ-8) | 11.75 score on a scale | Standard Deviation 3.41 |
| Supported MRP | Abbreviated Client Satisfaction Questionnaire (CSQ-8) | 12.92 score on a scale | Standard Deviation 2.29 |
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Acceptability of Intervention Measure (AIM) | 4.46 units on a scale | Standard Deviation 0.59 |
| Supported MRP | Acceptability of Intervention Measure (AIM) | 4.23 units on a scale | Standard Deviation 0.81 |
Primary
Completion Rate
Rate of intervention completion among eligible Veterans
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Enrolled Sample | Completion Rate | 28 Participants |
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)
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Credibility | 4.78 units on a scale | Standard Deviation 1.35 |
| Supported MRP | Credibility | 5.23 units on a scale | Standard Deviation 1.65 |
Primary
Eligibility Rate
Rate of eligibility among those screened for participation
Time frame: Day 0
Population: Screened individuals
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Enrolled Sample | Eligibility Rate | 38 Participants |
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Feasibility of Intervention Measure (FIM) | 4.12 units on a scale | Standard Deviation 0.48 |
| Supported MRP | Feasibility of Intervention Measure (FIM) | 3.77 units on a scale | Standard Deviation 0.9 |
Primary
Initiation Rate
Rate of intervention initiation among eligible Veterans
Time frame: Day 1
Population: Eligible individuals
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Enrolled Sample | Initiation Rate | 36 Participants |
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Intervention Appropriateness Measure (IAM) | 3.54 units on a scale | Standard Deviation 1.05 |
| Supported MRP | Intervention Appropriateness Measure (IAM) | 3.81 units on a scale | Standard Deviation 0.8 |
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Insomnia Severity Index | 15.79 score on a scale | Standard Deviation 7.64 |
| Supported MRP | Insomnia Severity Index | 12.14 score on a scale | Standard Deviation 8.17 |
Secondary
Mantram Practice
Frequency of mantram practice in the past week as 0-7 days
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Mantram Practice | 4.93 days/week | Standard Deviation 2.34 |
| Supported MRP | Mantram Practice | 5.00 days/week | Standard Deviation 1.75 |
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | Patient Health Questionnaire Depression Items (PHQ-9) | 11.50 score on a scale | Standard Deviation 8.13 |
| Supported MRP | Patient Health Questionnaire Depression Items (PHQ-9) | 9.86 score on a scale | Standard Deviation 6.56 |
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.
Time frame: Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Enrolled Sample | PTSD Checklist for DSM-5 (PCL-5) | 31.00 score on a scale | Standard Deviation 21.45 |
| Supported MRP | PTSD Checklist for DSM-5 (PCL-5) | 27.71 score on a scale | Standard Deviation 19.23 |