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临床试验/NCT04233853
NCT04233853已完成不适用

Improving Care for Patients with Depressive and Anxiety Disorders in Primary and Secondary Care: a Cluster-randomized Trial of a Consultation-liaison Intervention for General Practitioners

University of Zurich2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Change in depressive and anxiety symptoms

研究概览

简要总结

The CoLiPri study is a cluster randomized controlled trial funded by the Swiss National Science Foundation to evaluate the clinical and cost effectiveness as well as the implementation of a complex consultation-liaison intervention to help improve symptoms of anxiety and depression of screened patients in primary care. The intervention includes expert consultations, on demand referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic interventions and triage.

详细描述

Mental disorders such as depression or anxiety are serious and common health conditions that are highly prevalent in primary care. The primary care sector plays a key role in the treatment of common mental disorders as general practitioners (GPs) set the course for identification, diagnosis, therapy and referral to specialized treatment. The objectives of the CoLiPri study are to implement a complex consultation-liaison service at the intersection between primary and secondary care and to investigate its clinical and cost effectiveness in patients who are identified at primary care practices with elevated symptoms of depression and anxiety. Focus of the complex intervention is on improved collaboration and communication among GPs, mental health experts, and other services involved in the care of patients with common mental disorders. The novel service aims to support the decision-process at primary care practices, to increase access to evidence-based mental health treatment, and to help improve patients' pathways of care. The CoLiPri service for GPs include expert consultations, on-demand patient referral for structured diagnostics, and/or treatment planning, as well as brief psychotherapeutic interventions and triage. The effectiveness and cost effectiveness of the intervention as an add-on to enhanced usual primary care (usual care plus structured depression and anxiety screening) are evaluated in a cluster randomized clinical trial in screened patients with at least mild symptoms of depression and/or anxiety. In case of positive results, the service might serve as a model how to improve multi professional collaboration and clinical resource allocation for better delivery of mental health care.

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

入选标准

  • Patients scoring ≥5 on the PHQ-9 and/or scoring ≥5 on the GAD-7
  • Presenting and treated at the participating practice
  • Sufficient command of the German language
  • Individual signed informed consent

排除标准

  • Acute suicidality at the time of enrolment according to clinical evaluation
  • A history of psychotic symptoms
  • Bipolar Disorder Type-I or Type-II
  • Acute substance-related and addictive disorder (i.e. as primary diagnosis)
  • Severe cognitive impairment or other serious factors causing inability to follow the procedures of the study

结局指标

主要结局

Change in depressive and anxiety symptoms

时间窗: Baseline, 3 months, 6 months

Patient-reported depressive and anxiety symptoms will be assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) total score until 6-month follow-up. The PHQ-ADS combines the 9 items of the Depression Module of the PHQ (PHQ-9) and the 7 items of the General Anxiety Disorders 7 (GAD-7) to a single reliable and valid symptom measure. PHQ-ADS scores can range from 0 to 48 with higher scores indicating more severe depression/anxiety.

次要结局

  • Cost-effectiveness(Baseline, 6 months, 12 months)
  • Health-related quality of life(Baseline, 6 months, 12 months)
  • Health care utilization(Baseline, 6 months, 12 months)
  • Clinical response in depressive and anxiety symptoms(Baseline, 6 months)
  • Change in depressive and anxiety symptoms until 12-month follow-up(Baseline, 3 months, 6 months, 12 months)
  • Utility-based health-related quality of life(Baseline, 3 months, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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