DepressionCoLiPriNCT04233853
Consultation-Liaison Intervention for Patients with Depression and Anxiety in Primary Care
A study testing CoLiPri intervention and Usual primary care enhanced in people with Depression and Anxiety, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- CoLiPri intervention and Usual primary care enhanced
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jan 2020to 14 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- CoLiPri intervention, Usual primary care enhanced
- Keywords
- Primary mental care, Collaborative care, Health services research, Common mental disorders, Implementation, Disease management
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoLiPri interventionBehavioural
Also called Consultation-liaison service
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.
Usual primary care enhancedOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CoLiPri intervention | Experimental | 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. Receives: Behavioral: CoLiPri intervention; Other: Usual primary care enhanced |
| Usual primary care enhanced | Active comparator | 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. Receives: Other: Usual primary care enhanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Jan 2020
- Primary completion17 Oct 2023
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Birgit Watzke, Prof. Dr., Principal investigator, University of ZurichMarkus Wolf, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233853
- Sponsor's protocol ID
- 407440_167436
- Acronym
- CoLiPri
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04233853
- Acronym / sponsor ID
- CoLiPri / 407440_167436
- Conditions
- Depression, Anxiety
- Keywords
- Primary mental care, Collaborative care, Health services research, Common mental disorders, Implementation, Disease management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoLiPri intervention | Experimental | Behavioral: CoLiPri intervention, Other: Usual primary care enhancedGeneral 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. |
| Usual primary care enhanced | Active comparator | Other: Usual primary care enhancedUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoLiPri interventionAlso: Consultation-liaison serviceGeneral 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. | Behavioural | CoLiPri intervention |
| Usual primary care enhancedUsual 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 | CoLiPri intervention, Usual primary care enhanced |
Primary outcome
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.
6 secondary outcomes
Clinical response in depressive and anxiety symptoms
Time frame: Baseline, 6 months
Change in depressive and anxiety symptoms until 12-month follow-up
Time frame: Baseline, 3 months, 6 months, 12 months
Health-related quality of life
Time frame: Baseline, 6 months, 12 months
Health care utilization
Time frame: Baseline, 6 months, 12 months
Utility-based health-related quality of life
Time frame: Baseline, 3 months, 6 months, 12 months
Cost-effectiveness
Time frame: Baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Official website of the CoLiPri project (in German)Link provided by the sponsor.
- Brief project description at the SNSF National Research Program 74 "Smarter Healthcare"Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgit Watzke, Prof. Dr. principal investigator
University of Zurich
Markus Wolf, Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoLiPri intervention and Usual primary care enhanced in people with Depression and Anxiety, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive and anxiety symptoms (time frame: Baseline, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.