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

Primary Purpose

Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omnis Salutis
Health and Wellness
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress Disorders, Post-Traumatic focused on measuring Patient Participation, Psychosocial Functioning, Communication, Patient Satisfaction, Patient Preference

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Omnis Salutis

Health and Wellness

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
VA service use
VA service use data as collected from the electronic medical record

Full Information

First Posted
May 26, 2022
Last Updated
February 28, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05400252
Brief Title
Whole Health in VA Mental Health: Omnis Salutis
Acronym
OS RCT
Official Title
Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders, Substance-Related Disorders
Keywords
Patient Participation, Psychosocial Functioning, Communication, Patient Satisfaction, Patient Preference

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessors will be blind to participant intervention assignment.
Allocation
Randomized
Enrollment
238 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omnis Salutis
Arm Type
Experimental
Arm Description
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
Arm Title
Health and Wellness
Arm Type
Active Comparator
Arm Description
Health & Wellness is an educational wellness intervention
Intervention Type
Behavioral
Intervention Name(s)
Omnis Salutis
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health and Wellness
Intervention Description
Health & Wellness is an educational wellness intervention
Primary Outcome Measure Information:
Title
Veterans RAND 36-Item Health Survey - Physical Component Summary
Description
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.
Time Frame
6 months
Title
Veterans RAND 36-Item Health Survey - Social Functioning Scale
Description
overall social functioning in life; Item response are scored on a 5-point scale (possible range 0-4) with higher scores indicating better functioning.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Altarum Consumer Engagement - Commitment and Navigation subscales
Description
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
Time Frame
12 months
Title
VA service use
Description
VA service use data as collected from the electronic medical record
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Hack, PhD
Phone
(410) 637-1857
Email
samantha.hack@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Hack, PhD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Hack, PhD
Phone
410-637-1857
Email
samantha.hack@va.gov
First Name & Middle Initial & Last Name & Degree
Samantha Hack, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Whole Health in VA Mental Health: Omnis Salutis

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