N/A
N=36
Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health
Depression
Bottom Line
View on ClinicalTrials.gov: NCT05975008 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Military to Civilian Questionnaire — 27; 24.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Military to Civilian Questionnaire |
27; 24.7 | — |
| SECONDARY Patient Health Questionnaire |
6.4; 7.3 | — |
| SECONDARY Generalized Anxiety Disorder Scale |
10.4; 7.6 | — |
| SECONDARY Pain, Enjoyment, General Activity |
4.8; 4.5 | — |
| SECONDARY Five Facet Mindfulness Questionnaire |
12; 10; 9.8; 10.4; 10.8; 10 | — |
Summary
The purpose of this study is to test a mindfulness-based intervention to reduce depressive symptoms and improve Veterans' community reintegration.
Eligibility Criteria
Inclusion Criteria
Veteran participants must:
- be between 18-44 years old
- have served (a) active duty and/or (b) in the National Guard/Reserves, after October 2001 (can still be in the National Guard or Reservist)
- be enrolled in VHA care
- endorse at least "some" difficulty adjusting to civilian life to be eligible for participation. Difficulty adjusting to civilian life (i.e., reintegration challenges) will be assessed using the Military to Civilian Questionnaire (M2C-Q). For this study, "some" difficulty will be defined as a mean M2C-Q score of 2; the M2C-Q developers established a score of 2 as indicative of "some" reintegration difficulty and, as such, this is the score the investigators will use in the current study.
- endorse at least a moderate level of depression. The investigators will use the Patient Health Questionnaire (PHQ-9). to assess the presence and severity of depressive symptoms among potential Veteran participants. Moderate depression is defined as a score of 10-14 on the PHQ-9. This strategy for eligibility criteria optimally positions us to target Veterans who will likely benefit most from RECLAIM and to detect intervention effects in a future fully-powered follow-up trial.
Exclusion Criteria
- Veterans will not be immediately excluded from participation in the study; the study team will consult with the Roudebush Suicide Prevention Team and/or the Veterans' care provider to determine whether continued study participation is appropriate.
Data sourced from ClinicalTrials.gov (NCT05975008). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.