Collaborative care for depression in general practice: study protocol for a randomised controlled trial

Ursula Ødum Brinck-Claussen, Nadja Kehler Curth, Annette Sofie Davidsen, John Hagel Mikkelsen, Marianne Engelbrecht Lau, Merete Lundsteen, Claudio Csillag, Kaj Sparle Christensen, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov, Ursula Ødum Brinck-Claussen, Nadja Kehler Curth, Annette Sofie Davidsen, John Hagel Mikkelsen, Marianne Engelbrecht Lau, Merete Lundsteen, Claudio Csillag, Kaj Sparle Christensen, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov

Abstract

Background: Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection.

Methods/design: The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis.

Discussion: If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in general practice, with major benefit to patients and society. If case finding is shown to be superior to standard detection, it will be recommended as the detection method in future treatment according to the Collabri model.

Trial registration: ClinicalTrials.gov. NCT02678845 . Retrospectively registered on 7 February 2016.

Keywords: Cluster randomised trial; Collaborative care; Depression; Detection of depression; General practice; Illness recognition; Mood disorders; Shared care.

Conflict of interest statement

Ethical approval and consent to participate

The trial will be conducted in compliance with the Helsinki Declarations, the Collabri study protocol, and good clinical practice and guidelines, and will follow the rules for informed consent. No substantial deviation from the protocol will be implemented without prior review and approval of the regulatory authorities. Personally identifiable information collected in the study is treated according to the Danish Law on Personal Information (Lov om behandling af personoplysninger). Data are stored and kept confidential in secure cupboards and electronic data are stored in entry-restricted files. The study is also carried out in accordance with the applicable guidelines for social science research ethics. When communicating the results, participants and clinics will be anonymised. For every patient there is a case record form (CRF) marked with an identification number. Data on each patient are kept there. An identification list with the civil registration number (cpr. number) and case record numbers is stored in an entry-restricted folder on an internal electronic drive, separately from other patient-related material. The participants’ consent is voluntary and informed, and given both verbally and in writing. Previous international experience does not indicate that the intervention provided by the Collabri model is associated with side effects for the patients. In order to minimize the possible risks of discomfort, the research interviews are conducted in a flexible manner and interspersed with breaks if necessary. The extent of the interviews is a maximum of 2 hours and questionnaires take a maximum of an hour to complete. It is possible to fill out questionnaires in stages. If the participants experience the interview as stressful or uncomfortable, the interview can be conducted in stages or the participants can without further ado leave the trial, without it affecting their possibility of receiving current or future treatment. Prior to commencement, the project has been approved by the Regional Ethics Committees of the Capital Region of Denmark (identification no: H-3-2013-203) and approved by the Danish Data Protection Agency (ID number: 2007-58-0015, local journal no: RHP-2014-012) and by DSAMs Multi Practices Committee (ID number MPU 29-2013) and registered on ClinicalTrials.gov., identifier: NCT02678845. Results will be published in international journals. A Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist is available in Additional file 1.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow-chart for participants
Fig. 2
Fig. 2
Stepped-care plan

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