Clinical trial · Interventional
Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
People with severe mental illness have a substantially increased risk of undiagnosed and insufficiently treated somatic disease. Somatic Screening in the Capital Region Mental Health Service in Denmark (SomaScreen) is a service-level intervention implemented in psychiatric outpatient clinics in the Capital Region of Denmark to improve the detection and follow-up of somatic disease among patients with psychotic and affective disorders. This study evaluates whether integrating structured somatic screening into mental health services leads to improved identification and management of somatic disease compared with care as usual. Using a quasi-experimental controlled design with a matched cohort, outcomes among patients exposed to the SomaScreen intervention are compared with those of patients receiving usual care in comparable psychiatric outpatient clinics outside the Capital Region.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma (Diagnosis) | — | UNRESOLVED | — |
| Atrial Fibrillation (AF) | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chronic Obstructive Pulmonary Disease (COPD) | — | UNRESOLVED | — |
| Diabetes | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Psychiatric Patients, Serious Medical Illness | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SomaScreen Intervention Cohort
- description
- Patients in this arm receive the SomaScreen intervention, consisting of systematic somatic screening conducted by trained somatic nurses and general practitioner consultants in psychiatric outpatient clinics (F-ACT and OPUS). The intervention focuses on detecting cardiovascular disease, asthma, chronic obstructive pulmonary disease (COPD), diabetes, and cancer, but may also identify other somatic conditions. Patients with detected conditions are referred to their general practitioner for follow-up or further management. This cohort is distinguished from the control arm by exposure to the structured somatic screening intervention.
- interventionNames
- Diagnostic Test: Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)
- type
- NO_INTERVENTION
- label
- Matched Control Cohort (Care as Usual)
- description
- Patients in this arm receive standard psychiatric outpatient care at clinics in urban areas outside the Capital Region. They do not receive the SomaScreen somatic screening intervention. Control clinics are matched to intervention clinics at the cluster level using propensity score matching based on clinic-level characteristics, including average age, sex distribution, distribution of socioeconomic status, distribution of psychiatric diagnoses, Charlson Comorbidity Index (CCI), number of patients attached to the clinic, number of employed physicians, and number of employed nurses. These patients continue their usual care, including routine monitoring and management of somatic conditions by their general practitioner or secondary care providers. This cohort is distinguished from the intervention arm by the absence of structured somatic screening.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available