Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 737
- 试验地点
- 2
- 主要终点
- Change in depression severity (PHQ-D-9)
研究概览
简要总结
The main aim of the project is the implementation and evaluation of a stepped care model (SCM) for patients with depression with 6 treatment options of varying intensity and setting, including innovative technologies (e-mental health, telephone-based psychotherapy). Within this complex intervention, patients are treated by a multiprofessional network of health care providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a control group receiving treatment as usual (cluster randomization on the level of participating general practitioners). It is expected that the SCM condition will show better results regarding reduction of mental symptoms, improvement of quality of life, more efficient access to care and better cost-benefit ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>4 points on PHQ-D-9 depression scale
- •sufficient knowledge of German language
- •health situation that allows questionnaire completion
排除标准
- •insufficient knowledge of German language
- •health situation not allowing questionnaire completion
结局指标
主要结局
Change in depression severity (PHQ-D-9)
时间窗: Baseline, 3 months, 6 months, 12 months
Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel \& Herzog, 2002)
次要结局
- Quality of life (SF-12)(Baseline, 3 months, 6 months, 9 months)
- Health service utilization and medication consumption(Baseline, 6 months, 12 months)
- Self-esteem(Baseline, 3 months, 6 months, 12 months)
- Cost-benefit ratio (QALYs)(Baseline, 6 months, 12 months)
- Response/Remission/Relapse (PHQ-D-9)(Baseline, 3 months, 6 months, 12 months)
- Therapeutic alliance(Baseline, 3 months, 6 months, 12 months)
- Anxiety symptoms (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
- Somatisation (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
- Panic symptoms (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
- Quality of life (EQ-5D)(Baseline, 3 months, 6 months, 12 months)
- General anxiety disorder (GAD-7)(Baseline, 3 months, 6 months, 12 months)
研究者
PD Dr. phil. Birgit Watzke
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf