Holistic CareS&S WellnessNCT07452900
Using Integrated Care and Wearable Technology to Evaluate Outcomes of the Shields & Stripes Program for Veterans and First Responders
An observational study of Holistic Care and Mental Health, run by Baylor University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Holistic Care, Mental Health, Sleep
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of U.S. military veterans and first responders who have participated in the Shields \& Stripes 12-week multidisciplinary wellness program. The program integrates occupational therapy, mental health, physical therapy, and nutrition services. All data analyzed will be collected post-program completion, making the study primarily retrospective.
Who may be able to join
- 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.
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor University - Department of Occupational Therapy
Waco, Texas, 76798
Kelli Cabrera, OTD, 413-561-6105, kelli_Cabrera@baylor.edu
About this study
Official title: Evaluating Integrated Care and Wearable Technology Outcomes in the Shields & Stripes Program for Veterans and First Responders: A Retrospective Mixed-Methods Study
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.
Read more
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.
Read the 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.
- Conditions
- Holistic Care, Mental Health, Sleep, PTSD, Depression - Major Depressive Disorder, Anxiety
- 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
- Medical subject headings
- Psychological Well-Being, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shields & Stripes Program Participants | Participants include veterans and first responders who have completed the 12-week Shields \& Stripes holistic wellness program. The program integrates occupational therapy, mental health, physical therapy, and registered dietitian services to address physical, psychological, and occupational functioning. Data analyzed for this study include de-identified biometric, psychological, and laboratory outcomes collected as part of standard program procedures. Past and present program providers will also serve as participants to gain a better understanding of the program and its impact. No additional interventions are introduced for research purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale
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
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Psychological Functioning utilizing Patient Health Questionnaire-9 (PHQ-9)
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
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Psychological Functioning utilizing the Posttraumatic Stress Disorder Checklist (PCL-5)
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
Measured: Baseline (Week 0) to Post-Program (Week 12)
Secondary outcomes (19)
Change in Heart Rate Variability (HRV)
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.
Measured: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Health-Related Quality of Life - RAND 36-Item Health Survey (RAND-36)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Total Cholesterol
Change in total cholesterol measured via standard laboratory testing.
Unit of Measure:
mg/dL
Directionality:
Lower values indicate improved lipid profile.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Qualitative Themes from Semi-Structured Interviews
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)
Measured: Post-Program (within 4 weeks of completion)
Change in Physical Function and Performance (PSFS)
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
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Sleep Duration
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
Measured: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Sleep Efficiency
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.
Measured: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Resting Heart Rate
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.
Measured: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Physical Activity Level
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.
Measured: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Insomnia Severity - Insomnia Severity Index (ISI)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in HDL Cholesterol
Change in high-density lipoprotein (HDL) cholesterol measured via standard laboratory testing.
Unit of Measure:
mg/dL
Directionality:
Higher values indicate improved lipid profile.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in LDL Cholesterol
Change in low-density lipoprotein (LDL) cholesterol measured via standard laboratory testing.
Unit of Measure:
mg/dL
Directionality:
Lower values indicate improved lipid profile.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Triglycerides
Description:
Change in triglyceride levels measured via standard laboratory testing.
Unit of Measure:
mg/dL
Directionality:
Lower values indicate improved lipid profile.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Fasting Glucose
Description:
Change in fasting blood glucose measured via standard laboratory testing.
Unit of Measure:
mg/dL
Directionality:
Lower values indicate improved glycemic control.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Hemoglobin A1c (HbA1c)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Vitamin D (25-hydroxyvitamin D)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Change in Thyroid Stimulating Hormone (TSH)
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.
Measured: Baseline (Week 0) to Post-Program (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Holistic CareStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelli Cabrera, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452900
- Sponsor's protocol ID
- BU_SANDS_2025_01
- Acronym
- S&S Wellness
- Status last verified
- Mar 2026
- First submitted
- 12 Nov 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study involves retrospective analysis of de-identified data collected from participants in the Shields \& Stripes program. Individual participant data (IPD) will not be shared with other researchers outside the study team. Only aggregated, de-identified results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Integrated Care and Wearable Technology Outcomes in the Shields & Stripes Program for Veterans and First Responders: A Retrospective Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07452900
- Acronym / sponsor ID
- S&S Wellness / BU_SANDS_2025_01
- Conditions
- Holistic Care, Mental Health, Sleep, PTSD, Depression - Major Depressive Disorder, Anxiety
- Keywords
- Shields & Stripes, Veterans, First Responders, Occupational Therapy, Mental Health, Physical Therapy, Registered Dietitian, Integrated Wellness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Baylor UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shields & Stripes Program Participants | – | –Participants include veterans and first responders who have completed the 12-week Shields \& Stripes holistic wellness program. The program integrates occupational therapy, mental health, physical therapy, and registered dietitian services to address physical, psychological, and occupational functioning. Data analyzed for this study include de-identified biometric, psychological, and laboratory outcomes collected as part of standard program procedures. Past and present program providers will also serve as participants to gain a better understanding of the program and its impact. No additional interventions are introduced for research purposes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of U.S. military veterans and first responders who have participated in the Shields \& Stripes 12-week multidisciplinary wellness program. The program integrates occupational therapy, mental health, physical therapy, and nutrition services. All data analyzed will be collected post-program completion, making the study primarily retrospective.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale
Time frame: 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)
Time frame: 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)
Time frame: 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
19 secondary outcomes
Change in Heart Rate Variability (HRV)
Time frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Health-Related Quality of Life - RAND 36-Item Health Survey (RAND-36)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Total Cholesterol
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Qualitative Themes from Semi-Structured Interviews
Time frame: Post-Program (within 4 weeks of completion)
Change in Physical Function and Performance (PSFS)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Sleep Duration
Time frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Sleep Efficiency
Time frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Resting Heart Rate
Time frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Physical Activity Level
Time frame: Pre-Program (T-4 weeks), Program Start (Week 0), and Post-Program (Week 12)
Change in Insomnia Severity - Insomnia Severity Index (ISI)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in HDL Cholesterol
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in LDL Cholesterol
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Triglycerides
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Fasting Glucose
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Vitamin D (25-hydroxyvitamin D)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Change in Thyroid Stimulating Hormone (TSH)
Time frame: Baseline (Week 0) to Post-Program (Week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Official website for Shields \& Stripes, the multidisciplinary wellness program serving veterans and first responders participating in this study.Link provided by the sponsor.
- Official website for the Oura Ring, the wearable device used in this study to collect biometric data such as sleep, activity, and recovery measures.Link provided by the sponsor.
- Individual participant dataSharing planned: No. This study involves retrospective analysis of de-identified data collected from participants in the Shields \& Stripes program. Individual participant data (IPD) will not be shared with other researchers outside the study team. Only aggregated, de-identified results will be reported in publications and presentations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Holistic Care and Mental Health, run by Baylor University 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 4 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: opening soon, as of the sponsor's last update on 10 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelli Cabrera, OTD (413-561-6105, kelli_Cabrera@baylor.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological Functioning Generalized Anxiety Disorder 7-item (GAD-7) scale (time frame: Baseline (Week 0) to Post-Program (Week 12)). The study lists 3 primary outcomes in all. 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 10 Mar 2026.