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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

OS RCT Trial 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.

OS RCT Trial 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.

OS RCT Trial 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

OS RCT 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

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,214 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to participants under the age of twenty?

"Conforming to the terms of participation, this clinical trial is open for individuals aged 18-65."

Answered by AI

Is this investigation actively looking for new participants?

"According to clinicaltrials.gov, this specific medical trial is not currently enrolling new patients as the most recent update was on June 2nd 2022. However, there are 2355 other trials that are actively accepting participants at this time."

Answered by AI

What type of candidates are best suited for participating in this experiment?

"This clinical trial is searching for 238 people between 18 and 65 years old who have experienced anxiety in the past. As part of their application process, veterans must demonstrate they served since 2001, accessed Mental health Care within 6 months at a designated study site or after an extended gap in MH services, and present with PTSD (309.81), social anxiety disorder (300.23), panic disorder (300.01), generalized anxiety disorder (300.02), other specified/unspecified anxiety disorders (300.09 & 300.00) and substance use disorders like major depressive disorder(296)."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
District of Columbia
Maryland
How old are they?
18 - 65
What site did they apply to?
Washington DC VA Medical Center, Washington, DC
Martinsburg VA Medical Center, Martinsburg, WV
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2

Why did patients apply to this trial?

I've been struggling for 40+. THE TRIAL SITE SENT IT TO ME WITH HOPES I COULD APPLY AND BE ACCEPTED FOR THE TRIAL.
PatientReceived 1 prior treatment
I'm being told to get help often, and I don't want it to get too bad before trying to get help.
PatientReceived no prior treatments
Looking for anything that will stop my MDD w suicidal ideation and intent and self-harm, I've had Wellbutrin xl and Lexapro they did absolutely nothing even after waiting 6 weeks, Wellbutrin only gave me a migraine headache, Lexapro just did nothing, might as well been a placebo, and I am tired of trying this and that and living with the side effects, so if you have something new then please sign me up.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

WHAT CAN YOU EXPECT TIME WISE? HOW LONG CAN VISITS TAKE, WILL I NEED TO BE IN THE AREA TWO CONSECUTIVE DAYS?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Whole Health in VA Mental Health: Omnis Salutis
2023. "Whole Health in VA Mental Health: Omnis Salutis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05400252.
All > Anxiety Disorder > Ptsd
~146 spots leftby May 2026
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