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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RECLAIM intervention | Experimental | Eight 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness | Behavioral | Brief virtual mindfulness-based intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Generalized Anxiety Disorder Scale |
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Inclusion Criteria:
Veteran participants must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah A Shue, PhD MS BA | Richard L. Roudebush VA Medical Center, Indianapolis, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard L. Roudebush VA Medical Center, Indianapolis, IN | Indianapolis | Indiana | 46202-2884 | United States |
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Some participants were lost to follow-up (i.e., could not be contacted after enrolling in the study) or withdrew due to scheduling conflicts.
The investigators requested a list of Veterans and their contact information based on the study inclusion criteria via CDW. The research assistant mailed a recruitment brochure and letter to eligible Veterans. Study staff contacted eligible Veteran participants by phone and/or email to recruit them for the study. Veterans who enrolled were emailed using VA compliant methods. Word-of-mouth and snowballing techniques were also used to identify eligible Veteran participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | RECLAIM/Intervention | Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting. |
| FG001 | Psychoeducation Materials Only/Control Group | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RECLAIM/Intervention | Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting. |
| BG001 | Psychoeducation Materials Only/Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 days |
|
Adverse event data were collected from enrollment until follow-up assessments were completed, which was approximately 4 months for all participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RECLAIM/Intervention | Veteran participants randomized to the intervention group. Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting. |
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The investigators only included Veterans who were receiving VA care within one region of the country.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Shue | Richard L. Roudebush VA Medical Center | 317-988-0278 | sarah.shue@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2024 | Jan 6, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 30, 2023 | Feb 4, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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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.
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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 | 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 | 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 |
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.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Military to Civilian Questionnaire | The Military to Civilian Questionnaire (M2CQ) is a 16-item self-report tool assessing difficulties in areas like social relationships, work/school, self-care, and community engagement over the past 30 days using a 0-4 Likert scale (no to extreme difficulty) to gauge post-deployment reintegration. Scores can range from 0-64. Higher scores indicate greater reintegration difficulty. | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire | The Patient Health Questionnaire (PHQ-9) is a set of self-report questions to screen, diagnose, monitor, and measure the severity of depression symptoms. The PHQ-9 consists of 9 questions, each focusing on depressive symptoms over the past 2 weeks. Scores can range from 0-27 and higher scores indicate greater depression severity. | Mean | Standard Deviation | score on a scale |
|
| Generalized Anxiety Disorder Scale | The Generalized Anxiety Disorder Scale (GAD-7) is a brief, self-administered screening tool used to measure the presence and severity of anxiety symptoms. It consists of 7 questions and has a total score range from 0-21 and higher scores indicate greater frequency of anxiety symptoms. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| 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. | Mean | Standard Deviation | score on a scale |
|
| Psychoeducation Materials Only/Control Group |
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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 Week |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
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|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Psychoeducation Materials Only/Control Group | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Mindfulness Facet: Awareness |
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| Mindfulness Facet: Non-judging |
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| Mindfulness Facet: Non-reacting |
|