Clinical trial NCT05975008: Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health
Official title: Pilot Testing a Virtual Mindfulness-Based Intervention Aimed at Improving Reintegrating Veterans' Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: mindfulness
mental health
community reintegration
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-08-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed description: The overarching goal of the proposed project is to use mindfulness practices to reduce depression and improve community reintegration among post-9/11 Veterans. This proposal focuses on the REconnecting to Civilian Life using Activities that Improve Mindfulness (RECLAIM) intervention. RECLAIM is a virtual multi-component, mindfulness-based intervention developed by the study team in collaboration with VA clinicians, post-9/11 Veterans, and stakeholders and guided by the VA Whole Health framework. The proposed project builds on preliminary pilot work and a Small Award Initiative for Impact (SWIFT) pilot project funded by the VA HSR\&D Center of Innovation. In the SWIFT pilot, the investigators refined the RECLAIM content and tested the feasibility of virtual delivery with a small sample (N=18) using a single arm pre/post-test design. The proposed pilot project builds on preliminary work by (1) testing the refined intervention in a randomized controlled design to assess feasibility of recruitment for a randomized trial, (2) randomization, (3) retention in both study arms, and (4) intervention acceptability. Findings from the proposed project will support a HSR\&D Investigator Initiated Research Merit award application that will assess the effectiveness of RECLAIM while simultaneously planning for implementation in a Hybrid Type I trial. The following are the specific aims for this pilot project.

Aim 1: Conduct a randomized controlled pilot study to assess feasibility of the RECLAIM intervention. The investigators will conduct a two-arm randomized pilot study. Veterans (N=48) will be randomized to either the intervention arm (i.e., virtually delivered RECLAIM) or a control arm (i.e., psychoeducation materials). The investigators will assess intervention feasibility, including recruitment, randomization, administration and completion of outcome assessments, treatment engagement, and retention in both the intervention and control study arms.

Aim 2: Conduct qualitative interviews to assess acceptability of RECLAIM. A purposefully sampled subgroup (i.e., based on attendance) of RECLAIM participants (i.e., Veterans from the intervention arm; N=16) will engage in a qualitative interview to explore experiences in RECLAIM, including perceived strengths and suggestions for future improvements.

Aim 3: Refine and finalize the RECLAIM intervention. As findings emerge from the Aim 1 pilot test and Aim 2 interviews with Veteran participants, the investigators will iteratively update the RECLAIM protocol manual and testing procedures (i.e., randomization, control group materials). The investigators will consult with the Patient Advisory Council of the Indianapolis VAMC to gather Veteran feedback on the revised RECLAIM protocol manual, as well as partners (e.g., Patient Centered Care and Cultural Transformation). These actions will help refine the study methods, design, and intervention in anticipation of a larger trial.

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 we will use in the current study.
* endorse at least a moderate level of depression. We 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.

Primary outcomes:
measure: Military to Civilian Questionnaire
timeFrame: 30 days
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: 2 weeks
measure: Generalized Anxiety Disorder Scale
timeFrame: 2 weeks
measure: The Veterans RAND Health Survey
timeFrame: 4 weeks
measure: Five Facet Mindfulness Questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Richard L. Roudebush VA Medical Center, Indianapolis, IN
state: Indiana
Study officials:
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
name: Sarah A Shue, PhD MS BA
role: PRINCIPAL_INVESTIGATOR
References: