DepressionRECLAIMNCT05975008
Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health
A study testing RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness in people with Depression, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to test a mindfulness-based intervention to reduce depressive symptoms and improve Veterans' community reintegration. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 26 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness
- Keywords
- mindfulness, mental health, community reintegration
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECLAIM - Reconnecting to Civilian Life using Activities that Improve MindfulnessBehavioural
Brief virtual mindfulness-based intervention
| Study group | Role | What they receive |
|---|---|---|
| RECLAIM intervention | Experimental | Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start4 Dec 2023
- Primary completion6 Jan 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah A Shue, PhD MS BA, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975008
- Sponsor's protocol ID
- PPO 22-150
- Acronym
- RECLAIM
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2023
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Virtual Mindfulness-Based Intervention Aimed at Improving Reintegrating Veterans' Health Outcomes
- ClinicalTrials.gov ID
- NCT05975008
- Acronym / sponsor ID
- RECLAIM / PPO 22-150
- Conditions
- Depression
- Keywords
- mindfulness, mental health, community reintegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RECLAIM intervention | Experimental | Behavioral: RECLAIM - Reconnecting to Civilian Life using Activities that Improve MindfulnessEight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting. |
| 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECLAIM - Reconnecting to Civilian Life using Activities that Improve MindfulnessBrief virtual mindfulness-based intervention | Behavioural | RECLAIM intervention |
Primary outcome
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.
4 secondary outcomes
Patient Health Questionnaire
Time frame: 2 weeks
Generalized Anxiety Disorder Scale
Time frame: 2 weeks
Pain, Enjoyment, General Activity
Time frame: 1 Week
Five Facet Mindfulness Questionnaire
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Shue, PhD MS BA principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness in people with Depression, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Military to Civilian Questionnaire (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.