Trial Outcomes & Findings for Meditation in Veterans With PTSD and Mild TBI (NCT NCT02280304)
NCT ID: NCT02280304
Last Updated: 2020-03-09
Results Overview
Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.
COMPLETED
NA
46 participants
12 weeks
2020-03-09
Participant Flow
A total of 364 Veterans were pre-screened. Flyers were posted at the VA and at the University of Houston; however, most of the people who responded had been contacted in Mental Health and Neurology clinics.
Of 364 Veterans pre-screened, 85 were invited to come in for further eligibility assessment for PTSD, mTBI, and exclusionary disorders. Of these, 33 did not attend or excluded themselves, leaving 46 enrolled. Of these, 9 dropped out before group assignment, and 15 dropped out post group assignment, leaving a total of 22 finishing the study.
Participant milestones
| Measure |
Inner Resources for Veterans Meditation Therapy
Participants will complete meditation therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
PTSD and mTBI Education
Participants will learn about symptoms and triggers of PTSD and mTBI
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
18
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Inner Resources for Veterans Meditation Therapy
Participants will complete meditation therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
PTSD and mTBI Education
Participants will learn about symptoms and triggers of PTSD and mTBI
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
Baseline Characteristics
Missing Data. Scores fall in the range 0-80; higher scores indicate worse outcome
Baseline characteristics by cohort
| Measure |
Inner Resources for Veterans Meditation and Mantra Therapy
n=19 Participants
Participants complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
n=18 Participants
Participants learn about symptoms of PTSD and mTBI and coping skills for PTSD.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
37 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=37 Participants
|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 7.2 • n=19 Participants
|
36.1 years
STANDARD_DEVIATION 5.3 • n=18 Participants
|
36.2 years
STANDARD_DEVIATION 6.2 • n=37 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
5 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
32 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
2 Participants
n=19 Participants
|
5 Participants
n=18 Participants
|
7 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic
|
17 Participants
n=19 Participants
|
13 Participants
n=18 Participants
|
30 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
5 Participants
n=19 Participants
|
8 Participants
n=18 Participants
|
13 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
13 Participants
n=19 Participants
|
9 Participants
n=18 Participants
|
22 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Race · African American and Other
|
0 Participants
n=19 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=37 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=37 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
37 Participants
n=37 Participants
|
|
PTSD Checklist (PCL5)
|
47.9 units on a scale
STANDARD_DEVIATION 11.7 • n=16 Participants • Missing Data. Scores fall in the range 0-80; higher scores indicate worse outcome
|
52.6 units on a scale
STANDARD_DEVIATION 12.3 • n=12 Participants • Missing Data. Scores fall in the range 0-80; higher scores indicate worse outcome
|
49.8 units on a scale
STANDARD_DEVIATION 12.0 • n=28 Participants • Missing Data. Scores fall in the range 0-80; higher scores indicate worse outcome
|
|
PHQ-9 Depression
|
15.8 units on a scale
STANDARD_DEVIATION 5.1 • n=16 Participants • Missing data. Scores fall in the range 0-27; higher scores indicate worse outcome
|
17.4 units on a scale
STANDARD_DEVIATION 6.4 • n=12 Participants • Missing data. Scores fall in the range 0-27; higher scores indicate worse outcome
|
16.5 units on a scale
STANDARD_DEVIATION 5.6 • n=28 Participants • Missing data. Scores fall in the range 0-27; higher scores indicate worse outcome
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: One CAPS rater did not meet study criteria for expert CAPS administration; as a result, the CAPS data are not considered valid.
Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks and baselinePopulation: The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had MRI available and with acceptable quality assessment (i.e., not excluded because of excessive motion or sleepiness) for both time periods.
Functional connectivity was measured between the Default Mode Network (DMN) and lateral prefrontal cortex (LPFC), and between the amygdala and anterior cingulate. There were four seeds for the DMN (MPFC, PCC, left lateral parietal, right lateral parietal), and two seeds for the amygdala (right and left). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p\<.001 at the voxel level and p\<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.
Outcome measures
| Measure |
Inner Resources for Veterans (IRV) Mindfulness and Mantra
n=9 Participants
Participants will complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
n=11 Participants
Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
DMN (MPFC seed) to LPFC
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
DMN (PCC seed) to LPFC
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
DMN (RLP seed) to LPFC
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
DMN (LLP seed) to LPFC
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
Amygdala (right) to ACC
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control
Amygdala (left) to ACC
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeks and baselinePopulation: The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had completed the CRIS at both time periods.
Scores at baseline and 12 weeks in responses to the computerized version of the Community Reintegration in Service Members (CRIS-CAT) questionnaire in patients following meditation or control. There are three subscales: Extent of Participation (range 24-90), Perceived Limitations (range 33-99), and Satisfaction (range 34-91). Higher is better.
Outcome measures
| Measure |
Inner Resources for Veterans (IRV) Mindfulness and Mantra
n=8 Participants
Participants will complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
n=8 Participants
Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Community Reintegration in Service Members (CRIS)
Baseline Extent of Participation
|
34.1 score on a scale
Standard Deviation 5.3
|
36.4 score on a scale
Standard Deviation 3.7
|
|
Community Reintegration in Service Members (CRIS)
Baseline Perceived Limitations
|
37.3 score on a scale
Standard Deviation 3.5
|
38.9 score on a scale
Standard Deviation 4.6
|
|
Community Reintegration in Service Members (CRIS)
Baseline Satisfaction
|
38.0 score on a scale
Standard Deviation 3.9
|
38.4 score on a scale
Standard Deviation 3.4
|
|
Community Reintegration in Service Members (CRIS)
12 weeks Extent of Participation
|
34.9 score on a scale
Standard Deviation 6.0
|
38.2 score on a scale
Standard Deviation 6.2
|
|
Community Reintegration in Service Members (CRIS)
12 weeks Perceived Limitations
|
39.1 score on a scale
Standard Deviation 3.5
|
39.7 score on a scale
Standard Deviation 3.3
|
|
Community Reintegration in Service Members (CRIS)
12 weeks Satisfaction
|
38.6 score on a scale
Standard Deviation 5.1
|
39.7 score on a scale
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks, baselinePopulation: The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had completed PCL-5 at both time periods.
The PTSD Checklist 5 (PCL5) is a measure of PTSD symptoms based on DSM-V. The scores fall in the range 0-80; higher scores indicate worse outcome. We calculated the PTSD Checklist 5 (PCL5) difference score by subtracting the value at baseline minus the value at week 12. In this case higher scores represent a reduction in PTSD symptoms.
Outcome measures
| Measure |
Inner Resources for Veterans (IRV) Mindfulness and Mantra
n=10 Participants
Participants will complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
n=7 Participants
Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
PTSD Checklist 5 (PCL5) Difference Score
|
11.77 Score on a scale
Interval 0.0 to 80.0
|
5.58 Score on a scale
Interval 0.0 to 80.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeks, baselinePopulation: The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had PHQ-9 forms completed at both time periods.
The Patient Health Questionnaire-9 (PHQ-9) measure is a self-report measure of depression symptoms. Scores fall in the range 0-27; higher scores indicate worse outcome. This difference score denotes improvement in symptoms of depression. It was calculated by subtracting the value of PHQ-9 scores at baseline minus PHQ-9 scores scores at week 12.
Outcome measures
| Measure |
Inner Resources for Veterans (IRV) Mindfulness and Mantra
n=10 Participants
Participants will complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
n=7 Participants
Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9) Patient Depression Questionnaire Difference Score
|
5.0 Score on a scale
Interval 0.0 to 27.0
|
2.0 Score on a scale
Interval 0.0 to 27.0
|
POST_HOC outcome
Timeframe: 12 weeksPopulation: The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had MRI available and with acceptable quality assessment (i.e., not excluded because of excessive motion or sleepiness) for both time periods. Note that the sample sizes are identical to those reported in the secondary outcome section.
Within-group Post vs. Pre t-tests were done for each group with left and right hippocampal and parahippocampal gyrus (PHG) as seeds. Below are mean Fisher-transformed z scores and respective standard deviations of the Pearson's product correlation coefficients between the seed and cluster for each group. Positive mean z-scores scores reflect positive correlations between the seed and the cluster, and negative mean z-scores reflect negative correlations between the seed and the cluster. L IPL = left intraparietal lobule; VMPFC=ventromedial prefrontal cortex
Outcome measures
| Measure |
Inner Resources for Veterans (IRV) Mindfulness and Mantra
n=11 Participants
Participants will complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
n=9 Participants
Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Test of Additional Limbic Seeds (Hippocampal and Parahippocampal Gyri)
|
0.17 z-scores
Standard Deviation 0.07
|
0.15 z-scores
Standard Deviation 0.03
|
POST_HOC outcome
Timeframe: 12 weeksPopulation: Groups were combined to increase range of the sample size and to examine the general effect of therapy. Subjects (n=16; 9 IRV and 7 ES) were those who had both a post-therapy scan (regardless of therapy, IRV or ES) and CRIS-CAT scores prior to therapy.
The goal was to see if extent of participation in the community prior to therapy could predict the degree of functional connectivity between regions whose connectivity has been suggested to be part of a context processing network, disrupted during PTSD. The hippocampus was investigated because it is one of these regions. (The MPFC and thalamus are others.)
Outcome measures
| Measure |
Inner Resources for Veterans (IRV) Mindfulness and Mantra
n=16 Participants
Participants will complete meditation and mantra therapy
Inner Resources for Veterans (IRV): Meditation therapy which utilizes mindfulness, techniques that encourage non-judgmental attention to oneself in the present moment
|
Essential Skills Therapy
Participants will learn about symptoms of PTSD and mTBI and coping skills for PTSD
PTSD and mTBI education: Participants will learn about symptoms and triggers of PTSD and mTBI
|
|---|---|---|
|
Relating Extent of Participation in the Community (as Measured by the CRIS-CAT) Prior to Therapy to the Functional Connectivity of the Right Hippocampus After Therapy.
|
0.02 beta
|
—
|
Adverse Events
Inner Resources for Veterans Meditation Therapy
PTSD and mTBI Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place