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

NCT04233853 | Completed DMC

• 1 other identifier: 407440_167436
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety

Keywords

Primary mental care; Collaborative care; Health services research; Common mental disorders; Implementation; Disease management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Clinical response in depressive and anxiety symptoms

  Baseline, 6 months

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

  Baseline, 3 months, 6 months, 12 months

• Health-related quality of life

  Baseline, 6 months, 12 months

• Health care utilization

  Baseline, 6 months, 12 months

• Utility-based health-related quality of life

  Baseline, 3 months, 6 months, 12 months

Other Outcomes (7)

• Pathways of care

  12 months

• Physician-patient relationship

  Baseline, 6 months, 12 months

• Patient satisfaction in primary care

  3 months, 6 months, 12 months

Study Arms (2)

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.

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.

Other: Usual primary care enhanced

Interventions

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.

Also known as: Consultation-liaison service

CoLiPri intervention

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.

CoLiPri intervention; Usual primary care enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Heidelberg University: collaborator

Study Sites (1)

University of Zurich

Zurich, 8050, Switzerland

Location

Related Links

• Official website of the CoLiPri project (in German)
• Brief project description at the SNSF National Research Program 74 "Smarter Healthcare"

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Birgit Watzke, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Markus Wolf, Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: January 13, 2020
• Primary Completion: October 17, 2023
• Study Completion: April 14, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

CH (1)