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

VA Office of Research and Development36 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Depression

Interventions

RECLAIM - Reconnecting to Civilian Life using Activities that Improve MindfulnessBEHAVIORAL

Brief virtual mindfulness-based intervention

Eligibility

Sex: ALLMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

Patient Health Questionnaire

The 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.

Time frame: 2 weeks

Generalized Anxiety Disorder Scale

The 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.

Time frame: 2 weeks

Pain, Enjoyment, General Activity

The 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.

Time frame: 1 Week

Five Facet Mindfulness Questionnaire

The 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.

Data from ClinicalTrials.gov

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