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

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05400252

Collaborator

(none)

238

Enrollment

Locations

Arms

44.9

Anticipated Duration (Months)

79.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic Depressive Disorder Anxiety Disorders Substance-Related Disorders	Behavioral: Omnis Salutis Behavioral: Health and Wellness	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

238 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes assessors will be blind to participant intervention assignment.

Primary Purpose:

Health Services Research

Official Title:

Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

May 1, 2026

Anticipated Study Completion Date :

Oct 31, 2026

Arms and Interventions

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

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

Active Comparator: Health and Wellness

Health & Wellness is an educational wellness intervention

Behavioral: Health and Wellness

Health & Wellness is an educational wellness intervention

Outcome Measures

Primary Outcome Measures

Veterans RAND 36-Item Health Survey - Physical Component Summary [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 [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.

Secondary Outcome Measures

Altarum Consumer Engagement - Commitment and Navigation subscales [12 months]
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
VA service use [12 months]
VA service use data as collected from the electronic medical record

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington DC VA Medical Center, Washington, DC	Washington	District of Columbia	United States	20422
2	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland	United States	21201
3	Martinsburg VA Medical Center, Martinsburg, WV	Martinsburg	West Virginia	United States	25405