Whole Health in VA Mental Health: Omnis Salutis (OS RCT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Substance-Related Disorders; Depressive Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Omnis Salutis; Behavioral: Health and Wellness

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 Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045-7211
      • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omnis Salutis; 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	Behavioral: Omnis Salutis; 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
Active Comparator: Health and Wellness; Health & Wellness is an educational wellness intervention	Behavioral: Health and Wellness; Health & Wellness is an educational wellness intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
VA service use	VA service use data as collected from the electronic medical record	12 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Diana P Whitham, PhD MPH RD, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Patient Preference; Patient Participation; Communication; Patient Satisfaction; Psychosocial Functioning
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Mood Disorders; Stress Disorders, Traumatic; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Anxiety Disorders; Depressive Disorder; Substance-Related Disorders; Stress Disorders, Post-Traumatic; Communication; Patient Participation; Patient Preference; Patient Satisfaction; Population Characteristics; Health
• Other Study ID Numbers: D3938-R; 1I01RX003938-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No