Trial Outcomes & Findings for Pilot Trial of Mobile Mantram Delivery (NCT NCT05998967)
NCT ID: NCT05998967
Last Updated: 2024-03-21
Results Overview
Rate of eligibility among those screened for participation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Day 0
Results posted on
2024-03-21
Participant Flow
Recruited between December 2021 and August 2022 based on clinical referrals and lists of potential research participants
Participants had a primary clinical complaint of PTSD and an Internet-enabled device
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Trial of Mobile Mantram Delivery
Baseline characteristics by cohort
| Measure |
Self-directed Mantram Repetition Program (MRP)
n=17 Participants
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
|
Supported Mantram Repetition Program (MRP)
n=19 Participants
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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.29 years
STANDARD_DEVIATION 16.87 • n=5 Participants
|
49.79 years
STANDARD_DEVIATION 14.52 • n=7 Participants
|
50.50 years
STANDARD_DEVIATION 15.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Vanuatu
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
PTSD Checklist for DSM-5 (PCL-5)
|
35.94 units on a scale
STANDARD_DEVIATION 18.28 • n=5 Participants
|
30.56 units on a scale
STANDARD_DEVIATION 16.73 • n=7 Participants
|
33.17 units on a scale
STANDARD_DEVIATION 17.46 • n=5 Participants
|
|
Patient Health Questionnaire depression (PHQ-9)
|
11.47 units on a scale
STANDARD_DEVIATION 6.32 • n=5 Participants
|
10.58 units on a scale
STANDARD_DEVIATION 5.58 • n=7 Participants
|
11.00 units on a scale
STANDARD_DEVIATION 5.87 • n=5 Participants
|
|
Insomnia Severity Index (ISI)
|
15.94 units on a scale
STANDARD_DEVIATION 6.55 • n=5 Participants
|
13.00 units on a scale
STANDARD_DEVIATION 8.13 • n=7 Participants
|
14.39 units on a scale
STANDARD_DEVIATION 7.47 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Screened individuals
Rate of eligibility among those screened for participation
Outcome measures
| Measure |
Total Enrolled Sample
n=59 Participants
All Veterans screened for participation in the study
|
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
|
|---|---|---|
|
Eligibility Rate
|
38 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: Eligible individuals
Rate of intervention initiation among eligible Veterans
Outcome measures
| Measure |
Total Enrolled Sample
n=38 Participants
All Veterans screened for participation in the study
|
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
|
|---|---|---|
|
Initiation Rate
|
36 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 28Rate of intervention completion among eligible Veterans
Outcome measures
| Measure |
Total Enrolled Sample
n=38 Participants
All Veterans screened for participation in the study
|
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
|
|---|---|---|
|
Completion Rate
|
28 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 1Average Veteran perception of the logic, utility and expected benefit of treatment rated on a scale of 0 (not at all) to 8 (very)
Outcome measures
| Measure |
Total Enrolled Sample
n=17 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=19 Participants
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
|
|---|---|---|
|
Credibility
|
4.78 units on a scale
Standard Deviation 1.35
|
5.23 units on a scale
Standard Deviation 1.65
|
PRIMARY outcome
Timeframe: Day 28Degree 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.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Abbreviated Client Satisfaction Questionnaire (CSQ-8)
|
11.75 score on a scale
Standard Deviation 3.41
|
12.92 score on a scale
Standard Deviation 2.29
|
PRIMARY outcome
Timeframe: Day 28Perceived acceptability of the intervention as measured by an AIM average score. Scores range from 1-5 with higher scores indicating greater acceptability.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
|
4.46 units on a scale
Standard Deviation 0.59
|
4.23 units on a scale
Standard Deviation 0.81
|
PRIMARY outcome
Timeframe: Day 28Perceived appropriateness of the intervention as measured by an IAM average score. Scores range from 1-5 with higher scores indicating greater appropriateness.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Intervention Appropriateness Measure (IAM)
|
3.54 units on a scale
Standard Deviation 1.05
|
3.81 units on a scale
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: Day 28Perceived feasibility of the intervention as measured by an FIM average score. Scores range from 1-5 with higher scores indicating greater feasibility.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
|
4.12 units on a scale
Standard Deviation 0.48
|
3.77 units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Day 28Frequency of mantram practice in the past week as 0-7 days
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Mantram Practice
|
4.93 days/week
Standard Deviation 2.34
|
5.00 days/week
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Day 28PTSD symptoms at post-treatment as measured by the PCL-5 total score. Scores range from 0-80 with higher scores indicating greater PTSD symptoms.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
|
31.00 score on a scale
Standard Deviation 21.45
|
27.71 score on a scale
Standard Deviation 19.23
|
SECONDARY outcome
Timeframe: Day 28Depression at post-treatment as measured by the PHQ-9 total score. Scores range from 0-27 with higher scores indicating greater depression.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Patient Health Questionnaire Depression Items (PHQ-9)
|
11.50 score on a scale
Standard Deviation 8.13
|
9.86 score on a scale
Standard Deviation 6.56
|
SECONDARY outcome
Timeframe: Day 28Insomnia at post-treatment as measured by the ISI total score. Scores range from 0-28 with higher scores indicating greater insomnia.
Outcome measures
| Measure |
Total Enrolled Sample
n=14 Participants
All Veterans screened for participation in the study
|
Supported MRP
n=14 Participants
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
|
|---|---|---|
|
Insomnia Severity Index
|
15.79 score on a scale
Standard Deviation 7.64
|
12.14 score on a scale
Standard Deviation 8.17
|
Adverse Events
Self-directed MRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Supported MRP
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Self-directed MRP
n=17 participants at risk
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
|
Supported MRP
n=19 participants at risk
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
|
|---|---|---|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/17 • 4 week study period
|
5.3%
1/19 • Number of events 1 • 4 week study period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place