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Completed

NCT Number: NCT04233853

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

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, 8050, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoLiPri intervention

Behavioral

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: Consultation-liaison service

Usual primary care enhanced

Other

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.

Primary outcomes

  1. 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

  1. Clinical response in depressive and anxiety symptoms

    Time frame: Baseline, 6 months

    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.

  2. Change in depressive and anxiety symptoms until 12-month follow-up

    Time frame: Baseline, 3 months, 6 months, 12 months

    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.

  3. Health-related quality of life

    Time frame: Baseline, 6 months, 12 months

    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.

  4. Health care utilization

    Time frame: Baseline, 6 months, 12 months

    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.

  5. Utility-based health-related quality of life

    Time frame: Baseline, 3 months, 6 months, 12 months

    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).

  6. Cost-effectiveness

    Time frame: Baseline, 6 months, 12 months

    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.

Other outcomes

  1. Pathways of care

    Time frame: 12 months

    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.

  2. Physician-patient relationship

    Time frame: Baseline, 6 months, 12 months

    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).

  3. Patient satisfaction in primary care

    Time frame: 3 months, 6 months, 12 months

    The patients' satisfaction with GP treatment is assessed based on patient self-report with the Qualiskope-A.

  4. Therapeutic alliance

    Time frame: Each session, approx. at 1 month, 2 months, 3 months, 4 months

    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).

  5. General self-esteem

    Time frame: Each session, approx. at 1 month, 2 months, 3 months, 4 months

    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.

  6. Quality of therapy sessions

    Time frame: Each session, approx. at 1 month, 2 months, 3 months, 4 months

    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).

  7. Client satisfaction

    Time frame: 3 months, 6 months, 12 months

    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).

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Heidelberg University

Registry information

Official study 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

Acronym: CoLiPri

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 18, 2020
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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