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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

∙ 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)

Locations
United States
Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
ACTIVE_NOT_RECRUITING
Aurora
Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
RECRUITING
Baltimore
Contact Information
Primary
Alicia Lucksted, PhD
Alicia.Lucksted@va.gov
(410) 637-1858
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 238
Treatments
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
Active_comparator: Health and Wellness
Health \& Wellness is an educational wellness intervention
Authors
Samantha Hack
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov