Whole Health intervention for Veterans with mental health issues
Whole Health in VA Mental Health: A Randomized Controlled Trial of Omnis Salutis
NA · VA Office of Research and Development · NCT05400252
This study tests a program that helps recent Veterans from the Afghanistan and Iraq conflicts improve their mental health and overall well-being by teaching them how to set health goals and communicate better with their care providers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 238 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT05400252 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on recent Veterans from the Afghanistan and Iraq conflicts who are experiencing high rates of PTSD, depression, anxiety, and substance use disorders. The Omnis Salutis program is a three-session intervention designed to help Veterans understand Whole Health and effectively communicate their health goals to providers and social supports. The study aims to evaluate the impact of this intervention on Veterans' social and physical functioning, as well as their engagement in mental health care, through a large multisite randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates for this study are recent Veterans who have accessed mental health care services for the first time in the last six months and have a diagnosis of PTSD, depression, anxiety, or substance use disorders.
Not a fit: Patients with current diagnoses of psychotic disorders, such as schizophrenia or major depression with psychotic features, may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental and social functioning of Veterans suffering from stress-related disorders.
How similar studies have performed: Preliminary findings from previous studies indicate that similar interventions have shown feasibility and acceptability, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aurora, Colorado and 2 other locations
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora, Colorado, United States (RECRUITING)
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (RECRUITING)
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Diana P Whitham, PhD MPH RD — Rocky Mountain Regional VA Medical Center, Aurora, CO
- Study coordinator: Alicia Lucksted, PhD
- Email: Alicia.Lucksted@va.gov
- Phone: (410) 637-1858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Disorders, Post-Traumatic, Depressive Disorder, Anxiety Disorders, Substance-Related Disorders, Patient Participation, Psychosocial Functioning, Communication, Patient Satisfaction