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

January 27, 2026 updated by: VA Office of Research and Development

Pilot Testing a Virtual Mindfulness-Based Intervention Aimed at Improving Reintegrating Veterans' Health Outcomes

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sarah A Shue, PhD MS BA
  • Phone Number: (317) 988-9762
  • Email: sarah.shue@va.gov

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RECLAIM intervention
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
Brief virtual mindfulness-based intervention
No Intervention: Psychoeducation materials only
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Military to Civilian Questionnaire
Time Frame: 30 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire
Time Frame: 2 weeks
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.
2 weeks
Generalized Anxiety Disorder Scale
Time Frame: 2 weeks
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.
2 weeks
Pain, Enjoyment, General Activity
Time Frame: 1 Week
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.
1 Week
Five Facet Mindfulness Questionnaire
Time Frame: 2 months
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarah A Shue, PhD MS BA, Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PPO 22-150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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