- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04233853
Consultation-Liaison Intervention for Patients With Depression and Anxiety in Primary Care (CoLiPri)
July 17, 2023 updated by: University of Zurich
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Markus Wolf, Dr.
- Phone Number: +41 44 63 57318
- Email: markus.wolf@psychologie.uzh.ch
Study Locations
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-
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Zürich, Switzerland, 8050
- University of Zurich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CoLiPri intervention
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.
|
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.
Other Names:
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.
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Active Comparator: Usual primary care enhanced
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive and anxiety symptoms
Time Frame: Baseline, 3 months, 6 months
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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.
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Baseline, 3 months, 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response in depressive and anxiety symptoms
Time Frame: Baseline, 6 months
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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.
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Baseline, 6 months
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Change in depressive and anxiety symptoms until 12-month follow-up
Time Frame: Baseline, 3 months, 6 months, 12 months
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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.
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Baseline, 3 months, 6 months, 12 months
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Health-related quality of life
Time Frame: Baseline, 6 months, 12 months
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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.
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Baseline, 6 months, 12 months
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Health care utilization
Time Frame: Baseline, 6 months, 12 months
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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.
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Baseline, 6 months, 12 months
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Utility-based health-related quality of life
Time Frame: Baseline, 3 months, 6 months, 12 months
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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).
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Baseline, 3 months, 6 months, 12 months
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Cost-effectiveness
Time Frame: Baseline, 6 months, 12 months
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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.
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Baseline, 6 months, 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathways of care
Time Frame: 12 months
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Healthcare utilization and pathways of care will be assessed based semi-standardized telephone interviews with the Longitudinal Interval Follow-Up Evaluation (LIFE) administered at 12-month follow-up.
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12 months
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Physician-patient relationship
Time Frame: Baseline, 6 months, 12 months
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The perceived quality of the physician-patient relationship will measured based on patient-self report with the German version of the Patient Reaction Assessment (PRA-D).
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Baseline, 6 months, 12 months
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Patient satisfaction in primary care
Time Frame: 3 months, 6 months, 12 months
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The patients' satisfaction with GP treatment is assessed based on patient self-report with the Qualiskope-A.
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3 months, 6 months, 12 months
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Therapeutic alliance
Time Frame: Each session, approx. at 1 month, 2 months, 3 months, 4 months
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The therapeutic alliance is assessed after each individual CoLiPri session from the patient perspective with the German version of the Working Alliance Inventory-Short Revised (WAI-SR).
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Each session, approx. at 1 month, 2 months, 3 months, 4 months
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General self-esteem
Time Frame: Each session, approx. at 1 month, 2 months, 3 months, 4 months
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General self-esteem is measured with the revised version of the German Rosenberg Self-Esteem-Scale based patients self-report at each of the CoLiPri sessions within 12 months.
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Each session, approx. at 1 month, 2 months, 3 months, 4 months
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Quality of therapy sessions
Time Frame: Each session, approx. at 1 month, 2 months, 3 months, 4 months
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The quality of sessions delivered at the novel service will be monitored after each session within the 12 months with the patient version of the Bern Post Session Report (BPSR-P).
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Each session, approx. at 1 month, 2 months, 3 months, 4 months
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Client satisfaction
Time Frame: 3 months, 6 months, 12 months
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Client satisfaction with the CoLiPri services will be assessed in patients who have attended sessions based on patient self-report at 3-, 6-, and 12-month follow-up using the Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) which is the German version of the Client Satisfaction Questionnaire (CSQ-8).
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3 months, 6 months, 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Birgit Watzke, Prof. Dr., University of Zurich
- Principal Investigator: Markus Wolf, Dr., University of Zurich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2020
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
January 13, 2020
First Submitted That Met QC Criteria
January 16, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 17, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 407440_167436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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