IJff Marjoliek A, Huijbregts Klaas M L, van Marwijk Harm W J, Beekman Aartjan T F, Hakkaart-van Roijen Leona, Rutten Frans F, Unützer Jürgen, van der Feltz-Cornelis Christina M
Program Diagnosis and Treatment, Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands.
BMC Health Serv Res. 2007 Mar 1;7:34. doi: 10.1186/1472-6963-7-34.
Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries.
METHODS/DESIGN: This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months) are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36.
In this study, an American model to enhance care for patients with a depressive disorder, the collaborative care model, will be evaluated for effectiveness in the primary care setting. If effective across the Atlantic and across different health care systems, it is also likely to be an effective strategy to implement in the treatment of major depressive disorder in the Netherlands.
抑郁症是目前全球最具负担的疾病之一。抑郁症的循证治疗方法已然存在，但使用不足，且效果不如预期。美国早期的研究表明，基于协作护理方法、问题解决疗法和抗抑郁治疗算法来治疗抑郁症，效果良好，英国的研究也显示问题解决疗法有良好效果。尽管各国医疗保健系统不同，但这些治疗策略在荷兰可能也会非常有效。
方法/设计：本研究是一项双臂随机临床试验，在患者层面进行随机分组。该试验的目的是通过一个经过调整的协作护理框架来评估荷兰初级保健中抑郁症的治疗效果，该框架包括签约和改善依从性的策略，并结合问题解决疗法以及根据治疗算法使用抗抑郁药物。40家普通诊所将被随机分为干预组或对照组。纳入的患者将基于《精神疾病诊断与统计手册》第四版标准被诊断为中度至重度抑郁症，并根据合并的慢性躯体疾病进行分层。干预组的患者将接受基于协作护理方法的治疗，对照组的患者将接受常规护理。使用问卷和访谈来评估基线测量和随访测量（3、6、9和12个月）。主要结局指标是根据患者健康问卷9（PHQ9）评估的抑郁症状严重程度。次要结局指标是用PHQ9和抑郁症状快速量表（IDS-SR）测量的缓解情况，以及用TiC-P、欧洲五维健康量表（EQ-5D）和健康调查简表（SF-36）测量的成本效益。
在本研究中，将评估一种用于加强抑郁症患者护理的美国模式——协作护理模式在初级保健环境中的有效性。如果在大西洋两岸以及不同的医疗保健系统中都有效，那么它也很可能是荷兰治疗重度抑郁症的一种有效策略。
