Somatic health screening for adults in psychiatric outpatient care
Official title: Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) - Study Protocol for a Quasi-experimental Controlled Intervention Study With a Matched Cohort
Run by Amager Hospital · NCT07518446 · Data updated 2026-11-12
This program tries adding regular physical-health screening into psychiatric outpatient care to see if it helps detect and manage heart disease, lung disease, diabetes, and other conditions in adults with psychotic or affective disorders.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2800 (estimated) |
| Sponsor | Amager Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | September 1, 2024 |
| Main results expected | April 30, 2026 |
| Study ends | October 30, 2028 |
| Registry record updated | April 8, 2026 |
| Trial ID | NCT07518446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) starting a new outpatient treatment episode in FACT or OPUS psychiatric clinics with a diagnosis of psychotic or affective disorder (ICD-10 F20-F39), including those with comorbid substance use disorders.
✕Probably not a fit
People younger than 18, patients in geriatric outpatient clinics, or individuals without the target psychotic or affective diagnoses are not eligible and would not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SomaScreen is a service-level intervention that integrates structured somatic screening into psychiatric outpatient clinics in the Capital Region of Denmark and supports follow-up and transitions to general practice. The study uses a quasi-experimental controlled design with a matched cohort to compare outcomes for patients exposed to the SomaScreen intervention versus patients receiving usual care in comparable clinics outside the Capital Region. Key outcomes include detection rates of cardiovascular, respiratory, and metabolic conditions and subsequent management or referral to somatic care. The intervention targets adults starting new outpatient episodes in FACT or OPUS clinics and includes processes to improve continuity of care between psychiatric and general practice services.
Why it matters
Potential benefit: If successful, the program could lead to earlier detection and better follow-up of physical illnesses in people with severe mental illness, potentially reducing complications and premature mortality.
How similar studies have gone: Integrated somatic screening programs for people with severe mental illness have shown promise in improving detection of physical conditions, but evidence is mixed and robust controlled service-level evaluations remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 years or older. * Referred to FACT or OPUS psychiatric outpatient clinics in the Capital Region of Denmark. * Starting a new outpatient treatment episode in FACT or OPUS. * Diagnosed with psychotic or affective disorders (ICD-10 F20-F39), including those with comorbid substance use disorders (F10-F19). Exclusion Criteria: * Individuals younger than 18 years. * Patients in geriatric outpatient clinics. * Individuals not in the target diagnosis group (i.e., without psychotic or affective disorders, F20-F39). * Individuals who do not meet the inclusion criteria above.
Where it's running
-
Amager Hospital
Copenhagen, Denmark Recruiting
Study contacts
- Principal investigator: Lene F Eplov, MD, PhD, Associate Professor — Amager Hospital
- Study coordinator: Lene F Eplov, MD, PhD, Associate Professor
- Email: Lene.Falgaard.Eplov@regionh.dk
- Phone: +4520184687
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.