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FUNKTIONAL - Cluster randomised controlled evaluation of a guideline-based curriculum for early diagnosis and treatment of somatoform/functional disorders in general practice

FUNKTIONAL - Cluster randomised controlled evaluation of a guideline-based curriculum for early diagnosis and treatment of somatoform/functional disorders in general practice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27782834
Enrollment
2000
Registered
2005-11-04
Start date
2005-01-17
Completion date
Unknown
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatoform/functional complaints and disorders Mental and Behavioural Disorders Somatoform disorder

Interventions

In this trial we evaluate a training programme for general practitioners in early diagnosis and treatment of functional/somatoform complaints and disorders. The training programme is called FUNKTIONAL

Sponsors

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The participating doctors are general practitioners from the Rhein-Neckar-region. They were stratified by practice location (urban/rural) and training in Psychosocial Primary Care (PPC) (yes/no) and randomly assigned to the intervention group or to the control group. The following patients of these general practices were included in the study: 1. Aged 18 - 65 years 2. Patient has an appointment with the doctor (not only visits to the practice e.g. to fetch a prescription or to get the regular dose within a substitution therapy) Among the participating general practitioners there are 16 GPs in the intervention group and 16 GPs in the control group. 2000 patients are to be screened in the practices; 1000 in the intervention group, 1000 in the control group. We expect about 30% to be screening- positive accordant to our criteria (see inclusion criteria). Accordingly, around 600 patients will have a high symptom load, 300 in the intervention group and 300 in the control group.

Exclusion criteria

Exclusion criteria: The following patients were excluded from the study: 1. Age younger than 18 years or older than 65 years 2. Patient has no appointment with the doctor (e.g. visits the practice only to fetch a prescription or to get the regular dose within a substitution therapy) 3. Insufficient German language skills (language barrier) 4. Illiteracy 5. Psychosis 6. Mental disability 7. Impairment by severe acute organic disease

Design outcomes

Primary

MeasureTime frame
Health care utilisation

Secondary

MeasureTime frame
1. Evaluation of the curriculum 2. GPs' attitudes towards somatisation and provider satisfaction 3. Doctor-patient relationship and patient satisfaction 4. Symptomatology: 4.1. Somatisation 4.2. Comorbidity: depression, anxiety 5. Patients' quality of life 6. Patients' explanatory model, illness perception 7. Practice nurses' attitudes towards difficult patients 8. Team-oriented approach: cooperation between GP and practice nurses

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026