Evaluation of a specific psychosomatic short-term group intervention for patients with functional/ somatoform complaints in primary care. A cluster randomized controlled trial

Completed

• Conditions: Functional/ somatoform complaints and disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN55280791
• Lead Sponsor: German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 378

Inclusion Criteria

1,112 General Practitioners (GPs) within 45 minutes outreach around Heidelberg are invited to take part in the trial by letter. The first 36 of them who agree to participate are included in the trial. They are stratified by group experience (yes/no) and training in Psychosocial Primary Care (PPC) (yes/no) and randomly assigned to the intervention or control group.

The GPs recruit patients to participate in the trial according to following inclusion criteria:
1. The presence of functional/somatoform complaints (persistent [at least 6 months] bodily complaints for which no sufficient organic explanation can be found)
2. The somatoform disorder is the main treatment issue (co-morbidities are allowed)
3. Indication for short-term group intervention
4. Age 18-70 years
5. Distance from the practice to the place of residence not more than around 30 kilometers
6. Written informed consent

Patients selected by the GPs are additionally assessed for somatoform disorders by the Patient Health Questionnaire (PHQ-15) and the Whitely-7 (WI-7).

GPs' selection of patients is examined separately to assess its representativeness.

Exclusion Criteria

1. Ongoing psychotherapy
2. Substance abuse (benzodiazepins, alcohol, drugs)
3. Severe psychiatric disorder: major depression (PHQ-9), psychosis, dementia or neurodegenerative disorders
4. Impairment by severe acute organic disease (Karnofsky index lower than 70%)
5. Unable to understand German language
6. Ongoing juridical proceedings due to pension or compensation for personal suffering

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical quality of life (Physical Component Summary [PCS] of the Short From-36 Health Survey [SF-36]) will be assessed before the intervention and 3 and 9 months after the intervention.