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Clinical Trials/NCT04233853
NCT04233853
Completed
Not Applicable

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 Zurich1 site in 1 country82 target enrollmentJanuary 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Zurich
Enrollment
82
Locations
1
Primary Endpoint
Change in depressive and anxiety symptoms
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2020
End Date
April 14, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in depressive and anxiety symptoms

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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