Whole Health in VA Mental Health: Omnis Salutis (NCT05400252) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Whole Health in VA Mental Health: Omnis Salutis
United States238 participantsStarted 2023-02-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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)
* 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)
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Veterans RAND 36-Item Health Survey - Physical Component Summary
Timeframe: 6 months
2
Veterans RAND 36-Item Health Survey - Social Functioning Scale