Consultation-Liaison Intervention for Patients With Depression and Anxiety in Primary Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: CoLiPri intervention
* Other: Usual primary care enhanced


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoLiPri intervention<br>General practitioners and their screened patients have access to the consultation-liaison services for a total duration of 12 months, including standard screening, expert consultations, on demand patient referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic intervention and triage. | Behavioral: CoLiPri intervention<br>* General practitioners and their screened patients have access to the consultation-liaison services for a total duration of 12 months, including standard screening, expert consultations, on demand patient referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic intervention and triage.<br>* Other names: Consultation-liaison service;Other: Usual primary care enhanced<br>* Usual primary care practice as offered in routine care. Enhanced means that practitioners receive a basic training which consists of guideline-based structured screening procedures for depression and anxiety mental disorders in primary care.<br>|
| Active Comparator: Usual primary care enhanced<br>Usual primary care practice as offered in routine care. Enhanced means that practitioners receive a basic training which consists of guideline-based structured screening procedures for depression and anxiety mental disorders in primary care. | Other: Usual primary care enhanced<br>* Usual primary care practice as offered in routine care. Enhanced means that practitioners receive a basic training which consists of guideline-based structured screening procedures for depression and anxiety mental disorders in primary care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive and anxiety symptoms | 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. | Baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response in depressive and anxiety symptoms | Clinical response, defined as 50% reduction in 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. | Baseline, 6 months | 
| Change in depressive and anxiety symptoms until 12-month follow-up | Patient-reported depressive and anxiety symptoms will be assessed with the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) total score and subdomains, depression and anxiety, until 12-month follow-up. | Baseline, 3 months, 6 months, 12 months | 
| Health-related quality of life | Health-related quality of life (HrQoL) and health state based on patient self-report assessed with the Short Form Health Survey SF-12 total and physical and mental health subscales until 6 and 12 months follow-up. | Baseline, 6 months, 12 months | 
| Health care utilization | Patients' self-reported health care utilization will be measured with the Client Sociodemographic and Service Receipt Inventory-German Version (CSSRI-D) as a basis for health economic analyses. | Baseline, 6 months, 12 months | 
| Utility-based health-related quality of life | Utility-based health-related Quality of Life will be assessed via patient self-report with the five-level version of EQ-5D (EQ-5D-5L). | Baseline, 3 months, 6 months, 12 months | 
| Cost-effectiveness | Cost-effectiveness evaluated with the information on healthcare utilization and productivity losses (direct and indirect costs) assessed with the CSSRI-D accumulated during 6 and 12 months. Quality-adjusted life years (QALYs) will be determined based on EQ-5D-5L based utility. | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary mental care, Collaborative care, Health services research, Common mental disorders, Implementation, Disease management