Clinical trial NCT04233853: Consultation-Liaison Intervention for Patients with Depression and Anxiety in Primary Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Primary mental care
Collaborative care
Health services research
Common mental disorders
Implementation
Disease management
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2020-01-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in depressive and anxiety symptoms
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Clinical response in depressive and anxiety symptoms
timeFrame: Baseline, 6 months
measure: Change in depressive and anxiety symptoms until 12-month follow-up
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Health-related quality of life
timeFrame: Baseline, 6 months, 12 months
measure: Health care utilization
timeFrame: Baseline, 6 months, 12 months
measure: Utility-based health-related quality of life
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Cost-effectiveness
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Pathways of care
timeFrame: 12 months
measure: Physician-patient relationship
timeFrame: Baseline, 6 months, 12 months
measure: Patient satisfaction in primary care
timeFrame: 3 months, 6 months, 12 months
measure: Therapeutic alliance
timeFrame: Each session, approx. at 1 month, 2 months, 3 months, 4 months
measure: General self-esteem
timeFrame: Each session, approx. at 1 month, 2 months, 3 months, 4 months
measure: Quality of therapy sessions
timeFrame: Each session, approx. at 1 month, 2 months, 3 months, 4 months
measure: Client satisfaction
timeFrame: 3 months, 6 months, 12 months
Locations:
city: Zürich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: University of Zurich
name: Birgit Watzke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Markus Wolf, Dr.
role: PRINCIPAL_INVESTIGATOR
References: