Whole Health in VA Mental Health: Omnis Salutis
OS RCT
2 other identifiers
interventional
238
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
January 9, 2026
January 1, 2026
3.2 years
May 26, 2022
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
6 months
Secondary Outcomes (2)
Altarum Consumer Engagement - Commitment and Navigation subscales
12 months
VA service use
12 months
Study Arms (2)
Omnis Salutis
EXPERIMENTALOmnis 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 COMPARATORHealth \& Wellness is an educational wellness intervention
Interventions
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 \& Wellness is an educational wellness intervention
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana P Whitham, PhD MPH RD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessors will be blind to participant intervention assignment.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2022
First Posted
June 1, 2022
Study Start
February 1, 2023
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share