ISRCTN55280791已完成不适用
Evaluation of a specific psychosomatic short-term group intervention for patients with functional/ somatoform complaints in primary care. A cluster randomized controlled trial
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])0 个研究点目标入组 378 人开始时间: 2007年10月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 378
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
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