Image

Whole Health in VA Mental Health: Omnis Salutis

Whole Health in VA Mental Health: Omnis Salutis

Recruiting
18-65 years
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Stress Disorders
    Post-Traumatic
    Depressive Disorder
    Anxiety Disorders
    Substance-Related Disorders

NCT05400252

VA Office of Research and Development

17 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.