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NCT05400252 · ClinicalTrials.gov registry record · NA
Whole Health in VA Mental Health: Omnis Salutis
A NA study of Anxiety Disorders and Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 238
- Enrollment target
- 3
- Study locations
NCT05400252: Recruiting NA study of Anxiety Disorders and Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development.
NCT05400252 is a NA study of Anxiety Disorders and Stress Disorders, Post-Traumatic that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 238 participants, below the 1,137-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (79% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05400252, a NA study of Anxiety Disorders and Stress Disorders, Post-Traumatic, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 238 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Omnis Salutis
- BEHAVIORAL Health and Wellness
Study Locations (3)
Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD - Baltimore
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD - Baltimore
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
What NCT05400252 shows while recruiting
NCT05400252 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, below the 1,137-participant average among 84 other Anxiety Disorders trials with a reported enrollment target (79% lower).
The record links to 4 conditions, with Anxiety Disorders appearing as the primary indexed condition, and to 2 interventions - of which Omnis Salutis is the first listed.
NCT05400252 reports a single indexed study location in Maryland, Colorado.
Frequently Asked Questions
What is clinical trial NCT05400252 about?
NCT05400252 is a clinical study titled "Whole Health in VA Mental Health: Omnis Salutis". 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 d...
What is the current status of trial NCT05400252?
This trial is currently recruiting. It is a NA study. The enrollment target is 238 participants. The study started on 2023-02-01. Estimated completion is 2026-10-31.
What conditions does trial NCT05400252 study?
This clinical trial studies the following conditions: Anxiety Disorders, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Depressive Disorder.
What interventions are being tested in trial NCT05400252?
The interventions under investigation include: Omnis Salutis (BEHAVIORAL), Health and Wellness (BEHAVIORAL).
Who is sponsoring clinical trial NCT05400252?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05400252 being conducted?
This trial has 3 study locations across Colorado, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anxiety Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05400252's enrollment target sits among peer trials
238 22nd of 84 higher than 63 of 84 other Anxiety Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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