Trial Outcomes & Findings for Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health (NCT NCT05975008)
NCT ID: NCT05975008
Last Updated: 2026-01-28
Results Overview
The Military to Civilian Questionnaire (M2C-Q) is an empirically validated self-report scale that measures general difficulty in readjusting to civilian life by assessing important indicators of reintegration challenges over the past 30 days including social/health behaviors, specifically interpersonal relationships; productivity at school, work, or home; community participation; self-care; leisure; and perceived meaning in life. Scores can range from 0-64. Higher scores indicate greater reintegration difficulty.
COMPLETED
NA
36 participants
30 days
2026-01-28
Participant Flow
The investigators requested a list of Veterans and their contact information based on the study inclusion criteria via CDW. The research assistant mailed a recruitment brochure and letter to eligible Veterans. Study staff contacted eligible Veteran participants by phone and/or email to recruit them for the study. Veterans who enrolled were emailed using VA compliant methods. Word-of-mouth and snowballing techniques were also used to identify eligible Veteran participants.
Some participants were lost to follow-up (i.e., could not be contacted after enrolling in the study) or withdrew due to scheduling conflicts.
Participant milestones
| Measure |
RECLAIM/Intervention
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health
Baseline characteristics by cohort
| Measure |
RECLAIM/Intervention
n=18 Participants
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
n=18 Participants
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 Years
STANDARD_DEVIATION 7.3 • n=158 Participants
|
30 Years
STANDARD_DEVIATION 6 • n=157 Participants
|
30.5 Years
STANDARD_DEVIATION 6.6 • n=315 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
11 Participants
n=158 Participants
|
14 Participants
n=157 Participants
|
25 Participants
n=315 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
6 Participants
n=158 Participants
|
4 Participants
n=157 Participants
|
10 Participants
n=315 Participants
|
|
Sex/Gender, Customized
Gender · Not disclosed
|
1 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
6 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=158 Participants
|
13 Participants
n=157 Participants
|
30 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=158 Participants
|
2 Participants
n=157 Participants
|
5 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=158 Participants
|
14 Participants
n=157 Participants
|
26 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Military to Civilian Questionnaire
|
36.3 score on a scale
STANDARD_DEVIATION 12.7 • n=158 Participants
|
33.3 score on a scale
STANDARD_DEVIATION 7.5 • n=157 Participants
|
34.9 score on a scale
STANDARD_DEVIATION 10.4 • n=315 Participants
|
|
Patient Health Questionnaire
|
15.9 score on a scale
STANDARD_DEVIATION 5.8 • n=158 Participants
|
13.6 score on a scale
STANDARD_DEVIATION 3.6 • n=157 Participants
|
14.3 score on a scale
STANDARD_DEVIATION 4.8 • n=315 Participants
|
|
Generalized Anxiety Disorder Scale
|
12.6 score on a scale
STANDARD_DEVIATION 4.4 • n=158 Participants
|
14.1 score on a scale
STANDARD_DEVIATION 5.2 • n=157 Participants
|
13.5 score on a scale
STANDARD_DEVIATION 4.2 • n=315 Participants
|
|
Pain, Enjoyment, General Activity
|
4.4 score on a scale
STANDARD_DEVIATION 2.7 • n=158 Participants
|
5.1 score on a scale
STANDARD_DEVIATION 2.1 • n=157 Participants
|
4.7 score on a scale
STANDARD_DEVIATION 2.4 • n=315 Participants
|
|
Five Facet Mindfulness Questionnaire
Facet of Mindfulness: Observing
|
11 score on a scale
STANDARD_DEVIATION 4.1 • n=158 Participants
|
9.0 score on a scale
STANDARD_DEVIATION 3.5 • n=157 Participants
|
10.1 score on a scale
STANDARD_DEVIATION 3.9 • n=315 Participants
|
|
Five Facet Mindfulness Questionnaire
Facet of Mindfulness: Describing
|
9.5 score on a scale
STANDARD_DEVIATION 2.9 • n=158 Participants
|
8.4 score on a scale
STANDARD_DEVIATION 2.2 • n=157 Participants
|
9 score on a scale
STANDARD_DEVIATION 2.6 • n=315 Participants
|
|
Five Facet Mindfulness Questionnaire
Facet of Mindfulness: Awareness
|
10.5 score on a scale
STANDARD_DEVIATION 2 • n=158 Participants
|
7.7 score on a scale
STANDARD_DEVIATION 2.6 • n=157 Participants
|
9.2 score on a scale
STANDARD_DEVIATION 2.6 • n=315 Participants
|
|
Five Facet Mindfulness Questionnaire
Facet of Mindfulness: Non-judging
|
9 score on a scale
STANDARD_DEVIATION 3.7 • n=158 Participants
|
9.3 score on a scale
STANDARD_DEVIATION 1.3 • n=157 Participants
|
9.1 score on a scale
STANDARD_DEVIATION 2.7 • n=315 Participants
|
|
Five Facet Mindfulness Questionnaire
Facet of Mindfulness: Non-reacting
|
8.1 score on a scale
STANDARD_DEVIATION 2.5 • n=158 Participants
|
9.1 score on a scale
STANDARD_DEVIATION 3.6 • n=157 Participants
|
8.6 score on a scale
STANDARD_DEVIATION 3 • n=315 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe Military to Civilian Questionnaire (M2C-Q) is an empirically validated self-report scale that measures general difficulty in readjusting to civilian life by assessing important indicators of reintegration challenges over the past 30 days including social/health behaviors, specifically interpersonal relationships; productivity at school, work, or home; community participation; self-care; leisure; and perceived meaning in life. Scores can range from 0-64. Higher scores indicate greater reintegration difficulty.
Outcome measures
| Measure |
RECLAIM/Intervention
n=8 Participants
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
n=7 Participants
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
|---|---|---|
|
Military to Civilian Questionnaire
|
27 score on a scale
Standard Deviation 14.1
|
24.7 score on a scale
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: 2 weeksThe Patient Health Questionnaire (PHQ-9) is a reliable and valid 9-item measure of depression severity used to screen, diagnose, monitor, and measure the severity of depression. Scores can range from 0-27 and higher scores indicate greater depression severity.
Outcome measures
| Measure |
RECLAIM/Intervention
n=8 Participants
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
n=7 Participants
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
|---|---|---|
|
Patient Health Questionnaire
|
6.4 score on a scale
Standard Deviation 3.5
|
7.3 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 2 weeksThe Generalized Anxiety Disorder Scale (GAD-7) is a brief 7-item measure for assessing generalized anxiety disorder. It consists of 7 questions and has a total score range from 0-21 and higher scores indicate greater frequency of anxiety symptoms.
Outcome measures
| Measure |
RECLAIM/Intervention
n=8 Participants
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
n=7 Participants
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
|---|---|---|
|
Generalized Anxiety Disorder Scale
|
10.4 score on a scale
Standard Deviation 5.6
|
7.6 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 1 WeekThe Pain, Enjoyment, and General Activity (PEG) scale is a three-item assessment tool used to monitor chronic pain over time. Each item uses a numerical rating scale from 0 to 10. The scores on each of the 3 items (pain levels on average, pain interference with enjoyment, and pain interference with general activity) are summed and averaged to provide a score that will range from 0-10. Lower scores indicate minimal pain impact.
Outcome measures
| Measure |
RECLAIM/Intervention
n=8 Participants
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
n=7 Participants
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
|---|---|---|
|
Pain, Enjoyment, General Activity
|
4.8 score on a scale
Standard Deviation 3.2
|
4.5 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 2 monthsThe Five Facet Mindfulness Questionnaire (FFMQ-15) is a self-report scale that measures an individual's dispositional mindfulness across 5 distinct facets. Responses are made on a 5-point Likert scale, are totaled, and higher scores indicate greater mindfulness. The minimum possible score for each of the mindfulness facets is 3 and the maximum possible score is 15.
Outcome measures
| Measure |
RECLAIM/Intervention
n=8 Participants
Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
|
Psychoeducation Materials Only/Control Group
n=7 Participants
The investigators will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
|
|---|---|---|
|
Five Facet Mindfulness Questionnaire
Mindfulness Facet: Observing
|
12 score on a scale
Standard Deviation 2.8
|
10 score on a scale
Standard Deviation 1.4
|
|
Five Facet Mindfulness Questionnaire
Mindfulness Facet: Describing
|
9.8 score on a scale
Standard Deviation 3.4
|
10.4 score on a scale
Standard Deviation 1.3
|
|
Five Facet Mindfulness Questionnaire
Mindfulness Facet: Awareness
|
10.8 score on a scale
Standard Deviation 2.9
|
10 score on a scale
Standard Deviation 1.9
|
|
Five Facet Mindfulness Questionnaire
Mindfulness Facet: Non-judging
|
11.3 score on a scale
Standard Deviation 2.6
|
11.7 score on a scale
Standard Deviation 2
|
|
Five Facet Mindfulness Questionnaire
Mindfulness Facet: Non-reacting
|
10.1 score on a scale
Standard Deviation 1.7
|
9.6 score on a scale
Standard Deviation 1.3
|
Adverse Events
RECLAIM/Intervention
Psychoeducation Materials Only/Control Group
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