Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health

NCT05975008 | Completed Results

• 1 other identifier: PPO 22-150
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a mindfulness-based intervention to reduce depressive symptoms and improve Veterans' community reintegration.

Conditions

Depression

Keywords

mindfulness; mental health; community reintegration

Outcome Measures

Primary Outcomes (1)

• Military to Civilian Questionnaire

  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.

  30 days

Secondary Outcomes (4)

• Patient Health Questionnaire

  2 weeks

• Generalized Anxiety Disorder Scale

  2 weeks

• Pain, Enjoyment, General Activity

  1 Week

• Five Facet Mindfulness Questionnaire

  2 months

Study Arms (2)

RECLAIM intervention

EXPERIMENTAL

Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.

Behavioral: RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness

Psychoeducation materials only

NO INTERVENTION

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.

Interventions

RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness BEHAVIORAL

Brief virtual mindfulness-based intervention

RECLAIM intervention

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Limitations and Caveats

The investigators only included Veterans who were receiving VA care within one region of the country.

Results Point of Contact

• Title: Sarah Shue
• Organization: Richard L. Roudebush VA Medical Center

sarah.shue@va.gov

317-988-0278

Study Officials

• Sarah A Shue, PhD MS BA

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a pilot randomized controlled trial. Intervention arm participants will participate in the 8-week intervention. Control group participants will receive psychoeducation materials that the intervention group will also receive.

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 3, 2023
• Study Start: December 4, 2023
• Primary Completion: January 6, 2025
• Study Completion: March 26, 2025
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)