Stress Disorders, Post-TraumaticOS RCTNCT05400252
Whole Health in VA Mental Health: Omnis Salutis
A study testing Omnis Salutis and Health and Wellness in people with Stress Disorders, Post-Traumatic and Depressive Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Recent Veterans of the Afghanistan and Iraq conflicts are presenting in VA care with high rates of posttraumatic stress disorder (PTSD), depression, anxiety, and substance use disorders. Difficulties with social relationships and community reintegration are common functional impairments with these disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders
- What is being tested?
- Omnis Salutis and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2023to 31 Oct 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Per medical record review:
- military service since 2001
- Veteran accessed MHC service at designated study site for the first time in the last 6 months OR the first time in the last 6 months after at least a one year gap in mental health care
- have a current diagnosis of:
- PTSD (309.81)
- major depressive disorder (296.20-296.23, 296.30-296.33)
Show all 11Show fewer
- social anxiety disorder (300.23)
- panic disorder (300.01)
- generalized anxiety disorder (300.02)
- other specified or unspecified anxiety disorder (300.09, 300.00)
- substance use disorders (303.90, 304.00, 304.10, 304.30)
Who cannot join
- Per medical record review, current diagnosis of a psychotic disorder meeting criteria established by the VA Serious Mental Illness Treatment, Research, and Evaluation Center (SMITREC):
- schizophrenic disorders (295.0-295.9)
- affective psychoses (296.0-296.1, 296.4-296.8)
- major depression with psychotic features (296.24, 296.34)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis
Recent Veterans of the Afghanistan and Iraq conflicts are presenting in VA care with high rates of posttraumatic stress disorder (PTSD), depression, anxiety, and substance use disorders. Difficulties with social relationships and community reintegration are common functional impairments with these disorders. VA is transforming to a Whole Health, patient-centered system of care that will address these issues as part of health care. In a previous study, Omnis Salutis (OS) was developed with Veteran and clinician input. OS is a three-session intervention in which Veterans learn about Whole Health and practice communicating their health mission to providers and social supports. OS was shown feasible to deliver, acceptable to Veterans, and preliminarily effective at improving physical, mental, and social functioning. This study will use a large, multisite randomized controlled trial to test the impact of OS on Veterans' social and physical functioning and Veteran engagement in mental health care. Results will support broad delivery of OS throughout the VA.
Read the detailed description
Anticipated Impacts on Veteran Healthcare: Recent Veterans of the Operation Enduring Freedom, Operation Iraqi Freedom and Operation New Dawn (OIF/OEF/OND) conflicts are presenting in VA care with high rates of stress related mental health disorders (posttraumatic stress disorder, depression, anxiety, and alcohol abuse), and reporting significant difficulties with social relationships and community reintegration. Surveys of recent Veterans show that Veterans want the VA to provide mental health care tailored to their concerns and reintegration priorities; while simultaneously, the VA has committed to transforming to a Whole Health patient-centered, system of care. Within this context, Omnis Salutis, a brief, Veteran-focused, Whole Health activation intervention, was developed with a stakeholder advisory panel of Veterans, clinicians, and researchers. Preliminary findings indicate that participation in Omnis Salutis was associated with improvements in physical, mental and social functioning among recent Veterans with stress related mental health disorders.
Project Background: The term "recent Veterans" refers to Veterans who served in the OIF/OEF/OND military operations. Almost 60% (708,062) of recent Veterans who received VA care have been diagnosed with a mental health disorder, most commonly post-traumatic stress disorder (56%), depressive disorders (45%), anxiety disorders (44%), and substance use disorders (21%). Recent Veterans with stress-related mental health disorders experience impairment in functional domains of health (overcoming and managing disease), purpose (meaningful daily activities and participation in society), and community (positive relationships and social networks). Omnis Salutis is a three-session intervention in which Veterans learn about Whole Health and complete a brief Personal Health Inventory, practice creating and delivering MY MAP (Mission/Aspiration/Purpose) to communicate their health mission consistently to their providers and social supports; and identify both formal and informal healing relationships that support their health mission. Omnis Salutis was shown to be acceptable to and feasible in a previous small randomized controlled trial (n = 48). Additionally, analyses of the relationship between participation in Omnis Salutis and outcomes on the Veterans RAND 36-Item Health Survey found a large effect for Bodily Pain improvement, medium effect size for Social Functioning, small effect sizes for Physical Functioning, Emotional Well-Being, Energy/Fatigue, Role Limitations due to Emotional Problems, and General Health. These results are very promising and support further testing of Omnis Salutis.
Project Objectives: The proposed research will test the efficacy of Omnis Salutis, a brief, Veteran-focused, Whole Health activation intervention, in a randomized controlled trial (n = 238). The primary aim of the study is to evaluate the efficacy of Omnis Salutis for improving the physical and social functioning of recent Veterans with stress-related disorders. The secondary aim is to evaluate the efficacy of Omnis Salutis for increasing Veteran engagement in care for stress-related disorders. There is an exploratory aim to Evaluate the processes that underlie the relationship between engagement in care and functioning. This study will provide support for Omnis Salutis as an evidence-based practice and for broader dissemination.
Project Methods: The investigators propose a randomized controlled trial in a sample of 238 Veterans with stress-related mental health disorders recruited from four VA medical centers in Maryland, Washington DC, and West Virginia. Veterans will be randomly assigned to receive three sessions of Omnis Salutis or three sessions of an active control, health, and wellness intervention. Both conditions will be delivered via as VA Video Connect (VVC) telehealth platform or telephone. Participants will complete assessments at baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up timepoints. Analyses will examine differences in change over time between the two intervention conditions.
- Conditions
- Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders, Substance-Related Disorders
- Being tested
- Omnis Salutis, Health and Wellness
- Keywords
- Patient Participation, Psychosocial Functioning, Communication, Patient Satisfaction, Patient Preference
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders, Substance-Related Disorders, Patient Participation, Communication, Patient Satisfaction, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnis SalutisBehavioural
Omnis Salutis is a Veteran-targeted, Whole Health program for mental health care settings and teaches Veterans the skills to identify and communicate their Whole Health goals to providers and social supports
Health and WellnessBehavioural
Health \& Wellness is an educational wellness intervention
| Study group | Role | What they receive |
|---|---|---|
| Omnis Salutis | Experimental | Omnis Salutis is a Veteran-targeted, Whole Health program for mental health care settings and teaches Veterans the skills to identify and communicate their Whole Health goals to providers and social supports Receives: Behavioral: Omnis Salutis |
| Health and Wellness | Active comparator | Health \& Wellness is an educational wellness intervention Receives: Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans RAND 36-Item Health Survey - Physical Component Summary
overall physical functioning; Item response scales differ but are scored on a 3-, 5-, or 6-point scale (possible range 0-64). Item responses are summed with higher scores indicating better functioning.
Measured: 6 months
Veterans RAND 36-Item Health Survey - Social Functioning Scale
overall social functioning in life; Item response are scored on a 5-point scale (possible range 0-4) with higher scores indicating better functioning.
Measured: 6 months
Secondary outcomes (2)
Altarum Consumer Engagement - Commitment and Navigation subscales
patient engagement in health and healthcare decisions; Item responses are scored on a 5-point scale (possible range 0-4) with higher scores indicating better engagement
Measured: 12 months
VA service use
VA service use data as collected from the electronic medical record
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Feb 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Diana P Whitham, PhD MPH RD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400252
- Sponsor's protocol ID
- D3938-R
- Other IDs
- 1I01RX003938-01A1
- Acronym
- OS RCT
- Status last verified
- May 2026
- First submitted
- 26 May 2022
- Last updated
- 29 May 2026
- Results posted
- No
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis
- ClinicalTrials.gov ID
- NCT05400252
- Acronym / sponsor ID
- OS RCT / D3938-R
- Conditions
- Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders, Substance-Related Disorders
- Keywords
- Patient Participation, Psychosocial Functioning, Communication, Patient Satisfaction, Patient Preference
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 238 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 1 Jun 2022 (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.
Recent Veterans of the Afghanistan and Iraq conflicts are presenting in VA care with high rates of posttraumatic stress disorder (PTSD), depression, anxiety, and substance use disorders. Difficulties with social relationships and community reintegration are common functional impairments with these disorders. VA is transforming to a Whole Health, patient-centered system of care that will address these issues as part of health care. In a previous study, Omnis Salutis (OS) was developed with Veteran and clinician input. OS is a three-session intervention in which Veterans learn about Whole Health and practice communicating their health mission to providers and social supports. OS was shown feasible to deliver, acceptable to Veterans, and preliminarily effective at improving physical, mental, and social functioning. This study will use a large, multisite randomized controlled trial to test the impact of OS on Veterans' social and physical functioning and Veteran engagement in mental health care. Results will support broad delivery of OS throughout the VA.
Detailed description
Anticipated Impacts on Veteran Healthcare: Recent Veterans of the Operation Enduring Freedom, Operation Iraqi Freedom and Operation New Dawn (OIF/OEF/OND) conflicts are presenting in VA care with high rates of stress related mental health disorders (posttraumatic stress disorder, depression, anxiety, and alcohol abuse), and reporting significant difficulties with social relationships and community reintegration. Surveys of recent Veterans show that Veterans want the VA to provide mental health care tailored to their concerns and reintegration priorities; while simultaneously, the VA has committed to transforming to a Whole Health patient-centered, system of care. Within this context, Omnis Salutis, a brief, Veteran-focused, Whole Health activation intervention, was developed with a stakeholder advisory panel of Veterans, clinicians, and researchers. Preliminary findings indicate that participation in Omnis Salutis was associated with improvements in physical, mental and social functioning among recent Veterans with stress related mental health disorders.
Project Background: The term "recent Veterans" refers to Veterans who served in the OIF/OEF/OND military operations. Almost 60% (708,062) of recent Veterans who received VA care have been diagnosed with a mental health disorder, most commonly post-traumatic stress disorder (56%), depressive disorders (45%), anxiety disorders (44%), and substance use disorders (21%). Recent Veterans with stress-related mental health disorders experience impairment in functional domains of health (overcoming and managing disease), purpose (meaningful daily activities and participation in society), and community (positive relationships and social networks). Omnis Salutis is a three-session intervention in which Veterans learn about Whole Health and complete a brief Personal Health Inventory, practice creating and delivering MY MAP (Mission/Aspiration/Purpose) to communicate their health mission consistently to their providers and social supports; and identify both formal and informal healing relationships that support their health mission. Omnis Salutis was shown to be acceptable to and feasible in a previous small randomized controlled trial (n = 48). Additionally, analyses of the relationship between participation in Omnis Salutis and outcomes on the Veterans RAND 36-Item Health Survey found a large effect for Bodily Pain improvement, medium effect size for Social Functioning, small effect sizes for Physical Functioning, Emotional Well-Being, Energy/Fatigue, Role Limitations due to Emotional Problems, and General Health. These results are very promising and support further testing of Omnis Salutis.
Project Objectives: The proposed research will test the efficacy of Omnis Salutis, a brief, Veteran-focused, Whole Health activation intervention, in a randomized controlled trial (n = 238). The primary aim of the study is to evaluate the efficacy of Omnis Salutis for improving the physical and social functioning of recent Veterans with stress-related disorders. The secondary aim is to evaluate the efficacy of Omnis Salutis for increasing Veteran engagement in care for stress-related disorders. There is an exploratory aim to Evaluate the processes that underlie the relationship between engagement in care and functioning. This study will provide support for Omnis Salutis as an evidence-based practice and for broader dissemination.
Project Methods: The investigators propose a randomized controlled trial in a sample of 238 Veterans with stress-related mental health disorders recruited from four VA medical centers in Maryland, Washington DC, and West Virginia. Veterans will be randomly assigned to receive three sessions of Omnis Salutis or three sessions of an active control, health, and wellness intervention. Both conditions will be delivered via as VA Video Connect (VVC) telehealth platform or telephone. Participants will complete assessments at baseline, 3-month follow-up, 6-month follow-up, and 12-month follow-up timepoints. Analyses will examine differences in change over time between the two intervention conditions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnis Salutis | Experimental | Behavioral: Omnis SalutisOmnis Salutis is a Veteran-targeted, Whole Health program for mental health care settings and teaches Veterans the skills to identify and communicate their Whole Health goals to providers and social supports |
| Health and Wellness | Active comparator | Behavioral: Health and WellnessHealth \& Wellness is an educational wellness intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- military service since 2001
- Veteran accessed MHC service at designated study site for the first time in the last 6 months OR the first time in the last 6 months after at least a one year gap in mental health care
- have a current diagnosis of:
Key exclusion criteria (4 listed)
- Per medical record review, current diagnosis of a psychotic disorder meeting criteria established by the VA Serious Mental Illness Treatment, Research, and Evaluation Center (SMITREC):
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 |
|---|---|---|
| Omnis SalutisOmnis Salutis is a Veteran-targeted, Whole Health program for mental health care settings and teaches Veterans the skills to identify and communicate their Whole Health goals to providers and social supports | Behavioural | Omnis Salutis |
| Health and WellnessHealth \& Wellness is an educational wellness intervention | Behavioural | Health and Wellness |
Primary outcome
Veterans RAND 36-Item Health Survey - Physical Component Summary
Time frame: 6 months
overall physical functioning; Item response scales differ but are scored on a 3-, 5-, or 6-point scale (possible range 0-64). Item responses are summed with higher scores indicating better functioning.
Veterans RAND 36-Item Health Survey - Social Functioning Scale
Time frame: 6 months
overall social functioning in life; Item response are scored on a 5-point scale (possible range 0-4) with higher scores indicating better functioning.
2 secondary outcomes
Altarum Consumer Engagement - Commitment and Navigation subscales
Time frame: 12 months
VA service use
Time frame: 12 months
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 29 May 2026.
- 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.
Diana P Whitham, PhD MPH RD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnis Salutis and Health and Wellness in people with Stress Disorders, Post-Traumatic and Depressive Disorder, run by VA Office of Research and Development at 2 sites 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 11 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Veterans RAND 36-Item Health Survey - Physical Component Summary (time frame: 6 months). The study lists 2 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 29 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.