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

Abstract

BackgroundDepression 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/DesignThe 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.DiscussionIf 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 registrationClinicalTrials.gov. NCT02678845. Retrospectively registered on 7 February 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2064-7) contains supplementary material, which is available to authorized users.

Collaborative care for depression and anxiety disorders: results and lessons learned from the Danish cluster-randomized Collabri trials

“…The Collabri trials were designed as four clusterrandomized, researcher-blinded, superiority trials evaluating the effects of collaborative care according to the Collabri-model compared to treatment-as-usual for patients with depression, generalized anxiety disorder, panic disorder, and social anxiety disorder. The design is described in more detail in two study design publications [7,8]. The study adheres to CONSORT guidelines, and the Regional Ethics Committees in the Capital Region of Denmark approved the trial protocol.…”

“…Specifications and corrections should be made to the two study design papers [7,8]. For explorative subgroup analyses, we intended to obtain information about somatic comorbidities from GPs.…”

Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)

“…The collaborative care model tested in the trials is based on the former Collabri model [24, 25] and has been updated to incorporate key knowledge and experiences from the Collabri anxiety and depression trials. The Collabri Flex model complies with the collaborative care criteria [18, 19] in the following way: The model proposes a multi-professional approach to treatment that involves a GP, a care manager and a psychiatrist.The inter-professional communication is promoted through planned, regular contact.…”

“…As part of the HTA, a Danish collaborative care model for anxiety and depression was developed. Between 2014 and early 2017 the model was tested in the Capital Region of Denmark in four cluster-randomized superiority trials (the Collabri trials) comparing collaborative care with treatment as usual for depression, generalized anxiety disorder, social anxiety disorder and panic disorder [24, 25]. As collaborative care involves activities on the organizational level, such as ongoing supervision and support of the general practitioner (GP) by mental-health specialists, cluster randomization was chosen because of the considerable risk of control group contamination if randomization was performed on an individual level [26].…”

The work and challenges of care managers in the implementation of collaborative care: A qualitative study

“…Between 2014 and 2017, a Danish model of collaborative care for patients with anxiety and depression was tested and evaluated in the Capital Region of Denmark (Brinck‐Claussen et al., ; Curth et al., ). Professionals with psychiatric experience were employed as CMs, typically nurses with experience from psychiatry and a minimum of one year's training in CBT.…”