← Back to Search

Whole Health Intervention for PTSD (OS RCT Trial)

N/A
Recruiting
Led By Samantha Hack, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial will test the impact of a three-session intervention called Omnis Salutis (OS) on social and physical functioning of Veterans of the Afghanistan and Iraq conflicts. OS is designed to help Veterans learn about Whole Health and communicating their health mission to providers and social supports.

Who is the study for?
This trial is for Veterans who served since 2001 and are new to VA mental health care or returning after a gap. They must have PTSD, depression, various anxiety disorders, or substance use disorders but cannot participate if they have psychotic conditions like schizophrenia or major depression with psychotic features.Check my eligibility
What is being tested?
The study tests 'Omnis Salutis' (OS), a three-session intervention teaching Veterans about Whole Health and improving communication of their health mission. The goal is to enhance social/physical functioning and engagement in mental health care.See study design
What are the potential side effects?
Since OS involves educational sessions rather than medication, typical drug side effects aren't expected. However, discussing sensitive topics might cause temporary discomfort or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a mental health condition such as PTSD, depression, or an anxiety disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with a serious mental illness such as schizophrenia or major depression with psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Veterans RAND 36-Item Health Survey - Physical Component Summary
Veterans RAND 36-Item Health Survey - Social Functioning Scale
Secondary outcome measures
Altarum Consumer Engagement - Commitment and Navigation subscales
VA service use

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Omnis SalutisExperimental Treatment1 Intervention
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
Group II: Health and WellnessActive Control1 Intervention
Health & Wellness is an educational wellness intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Substance Use Disorders include Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and Contingency Management (CM). CBT helps patients recognize and change maladaptive behaviors and thought patterns, MI enhances motivation to change by resolving ambivalence, and CM uses positive reinforcement to encourage abstinence and treatment adherence. Education and communication skills training, as seen in the Omnis Salutis trial, empower patients by improving their understanding of health and enhancing their ability to communicate effectively with healthcare providers and social supports. These mechanisms are crucial as they address both the psychological and social aspects of SUD, promoting long-term recovery and better integration into society.
Curative factors in alcohol and drug treatment: behavioral and disease model perspectives.Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.Rediscovering fire: small interventions, large effects.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,741 Total Patients Enrolled
Samantha Hack, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Omnis Salutis Clinical Trial Eligibility Overview. Trial Name: NCT05400252 — N/A
Substance Use Disorders Research Study Groups: Health and Wellness, Omnis Salutis
Substance Use Disorders Clinical Trial 2023: Omnis Salutis Highlights & Side Effects. Trial Name: NCT05400252 — N/A
Omnis Salutis 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400252 — N/A
Substance Use Disorders Patient Testimony for trial: Trial Name: NCT05400252 — N/A
~128 spots leftby May 2026