Anxiety, Biometrics Measurement, Depression - Major Depressive Disorder, Holistic Care, Mental Health, Occupation, PTSD, Quality of Life, Recovery, Resilience, Sleep, Veteran
Conditions
Keywords
Shields & Stripes, Veterans, First Responders, Occupational Therapy, Mental Health, Physical Therapy, Registered Dietitian, Integrated Wellness, Biometric Data, Oura Ring, Sleep, Heart Rate Variability, PTSD, Anxiety, Depression, Quality of Life, Holistic Health, Multidisciplinary Rehabilitation, Functional Outcomes
Brief summary
This study aims to evaluate outcomes from the Shields & Stripes (S&S) program - a 12-week, multidisciplinary wellness intervention designed for veterans and first responders. The S&S program integrates occupational therapy (OT), mental health (MH), physical therapy (PT), and registered dietitian (RD) services to promote recovery, resilience, and performance in individuals who have experienced cumulative stress, trauma exposure, or occupational burnout. This research will use a retrospective mixed-methods observational design to analyze data collected from previous S&S participants who consent to research use of their de-identified information. No intervention or treatment changes will occur as part of this study. Quantitative data will include biometric information (e.g., sleep, activity, and heart rate variability via Oura Ring), standardized self-report measures (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), satisfaction surveys, and laboratory nutrition panels. Qualitative data will include semi-structured interviews with consenting participants and S&S providers following program completion. The purpose of the study is to identify patterns of improvement in physical, psychological, and occupational functioning and to explore how integrated, team-based care supports holistic recovery. Findings may inform the development of future evidence-based wellness programs for military and first-responder populations. Participation involves minimal risk, and all data will be de-identified before analysis.
Detailed description
Study Overview This retrospective mixed-methods observational study evaluates the effectiveness of the Shields & Stripes (S&S) program, a 12-week integrated wellness model that combines occupational therapy (OT), mental health (MH) services, physical therapy (PT), and registered dietitian (RD) support. The program serves veterans and first responders who experience cumulative physical, cognitive, and emotional stress related to their service. The study will retrospectively analyze quantitative and qualitative data from S&S cohorts between 2024-2026 to assess changes in health, functioning, and quality of life. Objectives Evaluate changes in physical, psychological, and occupational functioning following participation in S&S. Explore relationships between biometric indicators (e.g., heart-rate variability, sleep, activity) and self-reported well-being. Examine trends in nutrition and metabolic markers across cohorts. Analyze participant and provider perspectives through qualitative interviews to better understand mechanisms of change and perceived program value. Design and Methods Design: Convergent mixed-methods retrospective observational study. Quantitative Data: Includes biometric data (sleep, HRV, activity), self-report scales (GAD-7, PHQ-9, PCL-5, RAND-36, PSQI, ISI), and laboratory measures (cholesterol, glucose regulation, vitamin D, testosterone, thyroid, inflammatory markers, etc.). Qualitative Data: Semi-structured interviews with consenting participants and providers conducted post-program (via teleconference). Participants: Veterans and first responders aged 18-70 who have completed the S&S program and program providers who have worked within the S&S program. Recruitment: No direct external recruitment will occur for this study. All participants will be drawn from existing Shields & Stripes program cohorts and affiliated program providers, which utilize processes separate from this research. Data Handling: All data will be de-identified prior to analysis; stored securely on encrypted, access-restricted cloud servers. Primary Outcomes Change in self-reported anxiety (GAD-7) Change in depressive symptoms (PHQ-9) Change in PTSD symptoms (PCL-5) Change in sleep (PSQI and ISI) Change in quality of life (RAND-36) Change in sleep quality and recovery metrics (Oura Ring data) Secondary Outcomes Changes in nutritional and metabolic lab results (e.g., cholesterol, glucose, vitamin D, thyroid function). Qualitative themes related to perceived program benefit, barriers, and provider perspectives. Duration and Setting Data will be collected retrospectively from cohorts between 2024-2026. The study will take place remotely with data stored and analyzed by the research team. Risk and Safeguards The study is minimal risk. No interventions or procedures are performed beyond standard program participation. Risks are limited to potential discomfort during interviews and minimal risk of confidentiality breach, mitigated through HIPAA-compliant data handling. Expected Impact Results will inform how multidisciplinary programs combining OT, MH, PT, and RD services improve functional, psychological, and physiological outcomes among high-stress occupational populations. The study aims to contribute to the evidence base for integrated, holistic wellness approaches for veterans and first responders.
Interventions
None listed
Sponsors
Baylor University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-70 years * Current or former members of the U.S. Armed Forces or first responder professions (e.g., law enforcement, firefighting, EMS) * Participants who completed the Shields \& Stripes holistic wellness program * Providers who worked within the Shields and Stripes program.
Exclusion criteria
-None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale | Baseline (Week 0) to Post-Program (Week 12) | To assess changes in anxiety symptoms before and after participation in the 12-week Shields \& Stripes program using validated self-report measures. Score range: 0 to 21 Higher scores indicate: Worse anxiety symptoms |
| Change in Psychological Functioning utilizing Patient Health Questionnaire-9 (PHQ-9) | Baseline (Week 0) to Post-Program (Week 12) | To assess changes in depression symptoms before and after participation in the 12-week Shields \& Stripes program using validated self-report measures. Score range: 0 to 27 Higher scores indicate: Worse depressive symptoms |
| Change in Psychological Functioning utilizing the Posttraumatic Stress Disorder Checklist (PCL-5) | Baseline (Week 0) to Post-Program (Week 12) | To assess changes in post-traumatic stress symptoms before and after participation in the 12-week Shields \& Stripes program using validated self-report measures. Score range: 0 to 80 Higher scores indicate: Worse PTSD symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability (HRV) | Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) | Change in heart rate variability as measured by the Oura Ring wearable device. HRV will be reported as the nightly average root mean square of successive differences (RMSSD). Time Frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) Unit of Measure: Milliseconds (ms) Directionality: Higher values indicate better autonomic nervous system balance and recovery. |
| Change in Sleep Quality - Pittsburgh Sleep Quality Index (PSQI) | Baseline (Week 0) to Post-Program (Week 12) | Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI), a validated 19-item self-report questionnaire assessing sleep quality and disturbances over the past month. Time Frame: Baseline (Week 0) to Post-Program (Week 12) Unit of Measure: Total PSQI global score (range: 0 to 21) Directionality: Higher scores indicate worse sleep quality. |
| Change in Health-Related Quality of Life - RAND 36-Item Health Survey (RAND-36) | Baseline (Week 0) to Post-Program (Week 12) | Change in health-related quality of life as measured by the RAND 36-Item Health Survey (RAND-36), a validated self-report questionnaire assessing eight domains including physical functioning, role limitations (physical and emotional), energy/fatigue, emotional well-being, social functioning, pain, and general health perceptions. Time Frame: Baseline (Week 0) to Post-Program (Week 12) Unit of Measure: RAND-36 subscale scores transformed to a 0-100 scale. Directionality: Higher scores indicate better health-related quality of life and functioning. |
| Change in Total Cholesterol | Baseline (Week 0) to Post-Program (Week 12) | Change in total cholesterol measured via standard laboratory testing. Unit of Measure: mg/dL Directionality: Lower values indicate improved lipid profile. |
| Qualitative Themes from Semi-Structured Interviews | Post-Program (within 4 weeks of completion) | Participant and provider feedback will be collected using a semi-structured interview guide developed for this study. Thematic analysis will identify recurring themes related to participant satisfaction, perceived effectiveness, and experiences with integrated occupational therapy, mental health, physical therapy, and nutrition services. Time Frame: Post-Program (within 4 weeks of completion) Unit of Measure: Not applicable (qualitative thematic analysis) |
| Change in Physical Function and Performance (PSFS) | Baseline (Week 0) to Post-Program (Week 12) | Change in self-reported physical function measured by the Patient-Specific Functional Scale (PSFS), reflecting improvements in self-identified functional goals and mobility. Time Frame: Baseline (Week 0) to Post-Program (Week 12) Unit of Measure: Mean PSFS total score (0-10 scale) Directionality: Higher scores indicate better functional performance |
| Change in Sleep Duration | Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) | Change in total nightly sleep duration as measured by the Oura Ring wearable device. Time Frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) Unit of Measure: Hours (or minutes - choose one and stay consistent) Directionality: Higher values indicate longer sleep duration |
| Change in Sleep Efficiency | Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) | Change in sleep efficiency as measured by the Oura Ring wearable device. Sleep efficiency is calculated as the percentage of time in bed spent asleep. Time Frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) Unit of Measure: Percentage (%) Directionality: Higher values indicate better sleep quality. |
| Change in Resting Heart Rate | Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) | Change in resting heart rate as measured by the Oura Ring wearable device. Time Frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) Unit of Measure: Beats per minute (bpm) Directionality: Lower values generally indicate better cardiovascular fitness and recovery. |
| Change in Physical Activity Level | Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12) | Change in average daily activity level as measured by the Oura Ring wearable device. Unit of Measure: Oura Activity Score (0-100 scale) Directionality: Higher values indicate greater physical activity. |
| Change in Insomnia Severity - Insomnia Severity Index (ISI) | Baseline (Week 0) to Post-Program (Week 12) | Change in insomnia symptom severity as measured by the Insomnia Severity Index (ISI), a validated 7-item self-report questionnaire assessing perceived insomnia severity. Time Frame: Baseline (Week 0) to Post-Program (Week 12) Unit of Measure: Total ISI score (range: 0 to 28) Directionality: Higher scores indicate more severe insomnia symptoms. |
| Change in HDL Cholesterol | Baseline (Week 0) to Post-Program (Week 12) | Change in high-density lipoprotein (HDL) cholesterol measured via standard laboratory testing. Unit of Measure: mg/dL Directionality: Higher values indicate improved lipid profile. |
| Change in LDL Cholesterol | Baseline (Week 0) to Post-Program (Week 12) | Change in low-density lipoprotein (LDL) cholesterol measured via standard laboratory testing. Unit of Measure: mg/dL Directionality: Lower values indicate improved lipid profile. |
| Change in Triglycerides | Baseline (Week 0) to Post-Program (Week 12) | Description: Change in triglyceride levels measured via standard laboratory testing. Unit of Measure: mg/dL Directionality: Lower values indicate improved lipid profile. |
| Change in Fasting Glucose | Baseline (Week 0) to Post-Program (Week 12) | Description: Change in fasting blood glucose measured via standard laboratory testing. Unit of Measure: mg/dL Directionality: Lower values indicate improved glycemic control. |
| Change in Hemoglobin A1c (HbA1c) | Baseline (Week 0) to Post-Program (Week 12) | Description: Change in hemoglobin A1c (HbA1c), a measure of average blood glucose over approximately three months, measured via standard laboratory testing. Unit of Measure: Percent (%) Directionality: Lower values indicate improved glycemic control. |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline (Week 0) to Post-Program (Week 12) | Description: Change in high-sensitivity C-reactive protein (hs-CRP), a biomarker of systemic inflammation, measured via standard laboratory testing. Unit of Measure: mg/L Directionality: Lower values indicate reduced systemic inflammation. |
| Change in Vitamin D (25-hydroxyvitamin D) | Baseline (Week 0) to Post-Program (Week 12) | Description: Change in serum 25-hydroxyvitamin D levels measured via standard laboratory testing. Unit of Measure: ng/mL Directionality: Higher values indicate improvement toward normal vitamin D status. |
| Change in Thyroid Stimulating Hormone (TSH) | Baseline (Week 0) to Post-Program (Week 12) | Description: Change in thyroid stimulating hormone (TSH) levels measured via standard laboratory testing. Unit of Measure: mIU/L Directionality: Movement toward the normal reference range indicates improved thyroid function. |
Countries
United States
Contacts
CONTACTKelli Cabrera, OTD
Outcome results
None listed