RECRUITING

Whole Health in VA Mental Health: Omnis Salutis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis

Quick Facts

Study Start:2023-02-01
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05400252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * military service since 2001
  2. * 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
  3. * have a current diagnosis of:
  4. * PTSD (309.81)
  5. * major depressive disorder (296.20-296.23, 296.30-296.33)
  6. * social anxiety disorder (300.23)
  7. * panic disorder (300.01)
  8. * generalized anxiety disorder (300.02)
  9. * other specified or unspecified anxiety disorder (300.09, 300.00)
  10. * substance use disorders (303.90, 304.00, 304.10, 304.30)
  1. * 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):
  2. * schizophrenic disorders (295.0-295.9)
  3. * affective psychoses (296.0-296.1, 296.4-296.8)
  4. * major depression with psychotic features (296.24, 296.34)

Contacts and Locations

Study Contact

Alicia Lucksted, PhD
CONTACT
(410) 637-1858
Alicia.Lucksted@va.gov

Principal Investigator

Samantha Hack, PhD
PRINCIPAL_INVESTIGATOR
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Locations (Sites)

Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Colorado, 21201
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Samantha Hack, PhD, PRINCIPAL_INVESTIGATOR, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • Patient Participation
  • Psychosocial Functioning
  • Communication
  • Patient Satisfaction
  • Patient Preference

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic
  • Depressive Disorder
  • Anxiety Disorders
  • Substance-Related Disorders