Copenhagen Research Center for Mental Health - CORE, Mental Health Center Copenhagen, Mental Health Services, Gentofte Hospitalsvej 15, 2900, Hellerup, Denmark.
Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark.
BMC Fam Pract. 2020 Nov 18;21(1):234. doi: 10.1186/s12875-020-01299-3.
Meta-analyses suggest that collaborative care (CC) improves symptoms of depression and anxiety. In CC, a care manager collaborates with a general practitioner (GP) to provide evidence-based care. Most CC research is from the US, focusing on depression. As research results may not transfer to other settings, we developed and tested a Danish CC-model (the Collabri-model) for depression, panic disorder, generalized anxiety disorder, and social anxiety disorder in general practice.
Four cluster-randomized superiority trials evaluated the effects of CC. The overall aim was to explore if CC significantly improved depression and anxiety symptoms compared to treatment-as-usual at 6-months' follow-up. The Collabri-model was founded on a multi-professional collaboration between a team of mental-health specialists (psychiatrists and care managers) and GPs. In collaboration with GPs, care managers provided treatment according to a structured plan, including regular reassessments and follow-up. Treatment modalities (cognitive behavioral therapy, psychoeducation, and medication) were offered based on stepped care algorithms. Face-to-face meetings between GPs and care managers took place regularly, and a psychiatrist provided supervision. The control group received treatment-as-usual. Primary outcomes were symptoms of depression (BDI-II) and anxiety (BAI) at 6-months' follow-up. The incremental cost-effectiveness ratio (ICER) was estimated based on 6-months' follow-up.
Despite various attempts to improve inclusion rates, the necessary number of participants was not recruited. Seven hundred thirty-one participants were included: 325 in the depression trial and 406 in the anxiety trials. The Collabri-model was implemented, demonstrating good fidelity to core model elements. In favor of CC, we found a statistically significant difference between depression scores at 6-months' follow-up in the depression trial. The difference was not significant at 15-months' follow-up. The anxiety trials were pooled for data analysis due to inadequate sample sizes. At 6- and 15-months' follow-up, there was a difference in anxiety symptoms favoring CC. These differences were not statistically significant. The ICER was 58,280 Euro per QALY.
At 6 months, a significant difference between groups was found in the depression trial, but not in the pooled anxiety trial. However, these results should be cautiously interpreted as there is a risk of selection bias and lacking statistical power.
ClinicalTrials.gov, ID: NCT02678624 and NCT02678845 . Retrospectively registered on 7 February 2016.
荟萃分析表明，协作式护理（CC）可改善抑郁和焦虑症状。在 CC 中，护理经理与全科医生（GP）合作，提供基于证据的护理。大多数 CC 研究来自美国，主要针对抑郁症。由于研究结果可能不适用于其他环境，因此我们开发并测试了丹麦的 CC 模型（Collabri 模型），用于普通实践中的抑郁症、恐慌症、广泛性焦虑症和社交焦虑症。
四项聚类随机优势试验评估了 CC 的效果。总体目标是探讨 CC 是否在 6 个月随访时与常规治疗相比显著改善抑郁和焦虑症状。Collabri 模型基于精神科专家（精神科医生和护理经理）和全科医生之间的多专业合作。在与全科医生合作的过程中，护理经理根据结构化计划提供治疗，包括定期重新评估和随访。治疗方式（认知行为疗法、心理教育和药物治疗）根据逐步护理算法提供。全科医生和护理经理定期进行面对面会议，精神科医生提供监督。对照组接受常规治疗。主要结局是 6 个月随访时的抑郁症状（BDI-II）和焦虑症状（BAI）。根据 6 个月随访的结果，估算了增量成本效益比（ICER）。
尽管我们做了各种尝试来提高纳入率，但仍未招募到所需的参与者数量。共纳入 731 名参与者：抑郁症试验 325 名，焦虑症试验 406 名。Collabri 模型得到了实施，表现出对核心模型要素的良好遵从性。在 CC 方面，我们发现抑郁症试验中 6 个月随访时的抑郁评分存在统计学上的显著差异。15 个月随访时，这种差异并不显著。由于样本量不足，对焦虑症试验进行了汇总数据分析。在 6 个月和 15 个月的随访中，CC 对焦虑症状的改善存在差异，这一差异没有统计学意义。ICER 为 58280 欧元/质量调整生命年。
在 6 个月时，在抑郁症试验中发现了组间的显著差异，但在汇总的焦虑症试验中没有发现。然而，由于存在选择偏差和缺乏统计学效力的风险，这些结果应谨慎解释。
ClinicalTrials.gov，ID：NCT02678624 和 NCT02678845。于 2016 年 2 月 7 日回顾性注册。
