The effects of collaborative care versus consultation liaison for anxiety disorders and depression in Denmark: two randomised controlled trials.

BACKGROUND: Collaborative care (CC) and consultation liaison (CL) are two conceptual models aiming to improve mental healthcare in primary care. The effects of these models have not been compared in a Danish setting. AIMS: To examine the effects of CC versus CL for persons with anxiety and depression in Danish general practices (trial registration: NCT03113175 and NCT03113201). METHOD: Two randomised parallel superiority trials for anxiety disorders and depression were carried out in 2018-2019. In the CC-group, care managers collaborated with general practitioners (GPs) to provide evidence-based treatment according to structured treatment plans. They followed up and provided psychoeducation and/or cognitive-behavioural therapy. The GPs initiated pharmacological treatment if indicated, and a psychiatrist provided supervision. In the CL-group, the intervention consisted of the GP's usual treatment. However, the psychiatrist and care manager could be consulted. Primary outcomes were depression symptoms (Beck Depression Inventory-II, BDI-II) in the depression trial and anxiety symptoms (Beck Anxiety Inventory, BAI) in the anxiety trial at 6-month follow-up. RESULTS: In total, 302 participants with anxiety disorders and 389 participants with depression were included. A significant difference in BDI-II score was found in the depression trial, with larger symptom reductions in the CC-group (CC: 12.7, 95% CI 11.4-14.0; CL: 17.5, 95% CI 16.2-18.9; Cohen's d = -0.50, P ≤ 0.001). There was a significant difference in BAI in the anxiety trial (CC: 14.9, 95% CI 13.5-16.3; CL: 17.9, 95% CI 16.5-19.3; Cohen's d = -0.34, P ≤ 0.001), with larger symptom reductions in the CC-group. CONCLUSIONS: Collaborative care was an effective model to improve outcomes for persons with depression and anxiety disorders.

Improving the precision of depression diagnosis in general practice: a cluster-randomized trial.

BACKGROUND: Methods to enhance the accuracy of the depression diagnosis continues to be of relevance to clinicians. The primary aim of this study was to compare the diagnostic precision of two different diagnostic strategies using the Mini International Neuropsychiatric Interview (MINI) as a reference standard. A secondary aim was to evaluate accordance between depression severity found via MINI and mean Major Depression Inventory (MDI) sum-scores presented at referral. METHODS: This study was a two-armed, cluster-randomized superiority trial embedded in the Collabri trials investigating collaborative care in Danish general practices. GPs performing case-finding were instructed always to use MDI when suspecting depression. GPs performing usual clinical assessment were instructed to detect depression as they would normally do. According to guidelines, GPs would use MDI if they had a clinical suspicion, and patients responded positively to two or three core symptoms of depression. We compared the positive predictive value (PPV) in the two groups. RESULTS: Fifty-one GP clusters were randomized. In total, 244 participants were recruited in the case-finding group from a total of 19 GP clusters, and 256 participants were recruited in the usual clinical assessment group from a total of 19 GP clusters. The PPV of the GP diagnosis, when based on case-finding, was 0.83 (95% CI 0.78-0.88) and 0.93 (95% CI 0.89-0.96) when based on usual clinical assessment. The mean MDI sum-scores for each depression severity group indicated higher scores than suggested cut-offs. CONCLUSIONS: In this trial, systematic use of MDI on clinical suspicion of depression did not improve the diagnostic precision compared with the usual clinical assessment of depression. TRIAL REGISTRATION: The trial was retrospectively registered on 07/02/2016 at ClinicalTrials.gov. No. NCT02678845 .

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

BACKGROUND: Meta-analyses suggest that collaborative care (CC) improves symptoms of depression and anxiety. In CC, a care manager collaborates with a general practitioner (GP) to provide evidence-based care. Most CC research is from the US, focusing on depression. As research results may not transfer to other settings, we developed and tested a Danish CC-model (the Collabri-model) for depression, panic disorder, generalized anxiety disorder, and social anxiety disorder in general practice. METHODS: Four cluster-randomized superiority trials evaluated the effects of CC. The overall aim was to explore if CC significantly improved depression and anxiety symptoms compared to treatment-as-usual at 6-months' follow-up. The Collabri-model was founded on a multi-professional collaboration between a team of mental-health specialists (psychiatrists and care managers) and GPs. In collaboration with GPs, care managers provided treatment according to a structured plan, including regular reassessments and follow-up. Treatment modalities (cognitive behavioral therapy, psychoeducation, and medication) were offered based on stepped care algorithms. Face-to-face meetings between GPs and care managers took place regularly, and a psychiatrist provided supervision. The control group received treatment-as-usual. Primary outcomes were symptoms of depression (BDI-II) and anxiety (BAI) at 6-months' follow-up. The incremental cost-effectiveness ratio (ICER) was estimated based on 6-months' follow-up. RESULTS: Despite various attempts to improve inclusion rates, the necessary number of participants was not recruited. Seven hundred thirty-one participants were included: 325 in the depression trial and 406 in the anxiety trials. The Collabri-model was implemented, demonstrating good fidelity to core model elements. In favor of CC, we found a statistically significant difference between depression scores at 6-months' follow-up in the depression trial. The difference was not significant at 15-months' follow-up. The anxiety trials were pooled for data analysis due to inadequate sample sizes. At 6- and 15-months' follow-up, there was a difference in anxiety symptoms favoring CC. These differences were not statistically significant. The ICER was 58,280 Euro per QALY. CONCLUSIONS: At 6 months, a significant difference between groups was found in the depression trial, but not in the pooled anxiety trial. However, these results should be cautiously interpreted as there is a risk of selection bias and lacking statistical power. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02678624 and NCT02678845 . Retrospectively registered on 7 February 2016.

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).

BACKGROUND: Models of collaborative care and consultation liaison propose organizational changes to improve the quality of care for people with common mental disorders, such as anxiety and depression. Some literature suggests only short-term positive effects of consultation liaison on patient-related outcomes, whereas collaborative care demonstrates both short-term and long-term positive effects. To our knowledge, only one randomized trial has compared the effects of these models. Collaborative care was superior to consultation liaison in reducing symptoms of depression for up to 3 months, but the authors found no difference at 9-months' follow-up. The Collabri Flex Trial for Depression and the Collabri Flex Trial for Anxiety aim to compare the effects of collaborative care with those of a form of consultation liaison that contains potential contaminating elements from collaborative care. The trials build on knowledge from the previous cluster-randomized Collabri trials. METHODS: Two randomized, investigator-initiated, parallel-group, superiority trials have been established: one investigating the effects of collaborative care vs consultation liaison for depression and one investigating the effects of collaborative care vs consultation liaison for generalized anxiety, panic disorder and social anxiety disorder at 6-months' follow-up. Participants are recruited from general practices in the Capital Region of Denmark: 240 in the depression trial and 284 in the anxiety trial. The primary outcome is self-reported depression symptoms (Beck Depression Inventory (BDI-II)) in the depression trial and self-reported anxiety symptoms (Beck Anxiety Inventory (BAI)) in the anxiety trial. In both trials, the self-reported secondary outcomes are general psychological problems and symptoms (Symptom Checklist 90-Revised), functional impairment (Sheehan Disability Scale) and general well-being (World Health Organization-Five Well-Being Index). In the depression trial, BAI is an additional secondary outcome, and BDI-II is an additional secondary outcome in the anxiety trial. Explorative outcomes will also be collected. DISCUSSION: The results will supplement those of the cluster-randomized Collabri trials and provide pivotal information about the effects of collaborative care in Denmark. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03113175 and NCT03113201 . Registered on 13 April 2017.

Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials.

BACKGROUND: People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders. METHODS: Three cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months. DISCUSSION: Results will add to the limited pool of information about collaborative care for patients with anxiety disorders. To our knowledge, these will be the first carried out in a Danish context and the first to report results for generalised anxiety and social phobia separately. If the trials show positive results, they could contribute to the improvement of future treatment of anxiety disorders. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02678624 . Retrospectively registered 7 February 2016; last updated 15 August 2016.

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

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.