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

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ClinicalTrials.gov Identifier: NCT04233853
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: CoLiPri intervention Other: Usual primary care enhanced Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
Behavioral: 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.
Other Name: Consultation-liaison service

Other: 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.

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.
Other: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233853


Contacts
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Contact: Markus Wolf, Dr. +41 44 63 57318 markus.wolf@psychologie.uzh.ch

Locations
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Switzerland
University of Zurich Recruiting
Zürich, Switzerland, 8050
Contact: Birgit Watzke, Prof. Dr.         
Sponsors and Collaborators
University of Zurich
Heidelberg University
Investigators
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Principal Investigator: Birgit Watzke, Prof. Dr. University of Zurich
Principal Investigator: Markus Wolf, Dr. University of Zurich
Additional Information:
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04233853    
Other Study ID Numbers: 407440_167436
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Primary mental care
Collaborative care
Health services research
Common mental disorders
Implementation
Disease management
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders