Study protocol for the COMET study: a cluster-randomised, prospective, parallel-group, superiority trial to compare the effectiveness of a collaborative and stepped care model versus treatment as usual in patients with mental disorders in primary care

Abstract

IntroductionMental healthcare is one of the biggest challenges for healthcare systems. Comorbidities between different mental disorders are common, and patients suffer from a high burden of disease. While the effectiveness of collaborative and stepped care models has been shown for single disorders, comorbid mental disorders have rarely been addressed in such care models. The aim of the present study is to evaluate the effectiveness of a collaborative and stepped care model for depressive, anxiety, somatoform and alcohol use disorders within a multiprofessional network compared with treatment as usual.Methods and analysisIn a cluster-randomised, prospective, parallel-group superiority trial, n=570 patients will be recruited from primary care practices (n=19 practices per group). The intervention is a newly developed collaborative and stepped care model in which patients will be treated using treatment options of various intensities within an integrated network of outpatient general practitioners, psychiatrists, psychotherapists and inpatient institutions. It will be compared with treatment as usual with regard to effectiveness, cost-effectiveness and feasibility, with the primary outcome being a change in mental health-related quality of life from baseline to 6 months. Patients in both groups will undergo an assessment at baseline, 3, 6 and 12 months after study inclusion.Ethics and disseminationThe study has been approved by the ethics committee of the Hamburg Medical Association (No. PV5595) and will be carried out in accordance with the principles of the Declaration of Helsinki. For dissemination, the results will be published in peer-reviewed journals and presented at conferences. Within the superordinate research project Hamburg Network for Health Services Research, the results will be communicated to relevant stakeholders in mental healthcare.Trial registration number NCT03226743.

Psychotherapists’ perspectives on collaboration and stepped care in outpatient psychotherapy—A qualitative study

“…The present study was conducted in the context of a randomized-controlled trial on stepped care for patients with depression, anxiety, somatoform and alcohol-related disorders (COMET, Clinical trial registration No. NCT03226743; [23]). Psychotherapists were recruited inside and outside the RCT-cohort.…”

Self-reported work ability predicts health-related exit and absence from work, work participation, and death: longitudinal findings from a sample of German employees

“…Risk-adjusted and stepped-care models are approaches that may achieve both efficient use of resources and access to coordinated care by establishing treatments of different levels of intensity. This model is well known from psychiatric care (Heddaeus et al 2019 ) and has already been applied in occupational medicine and disability management (Aust et al 2015 ; Poulsen et al 2014 ; van Holland et al 2012 ). In these models, the severity of symptoms or the prognosis determines the initial treatment choice.…”

At the Heart of Neurological Dimensionality: Cross-Nosological and Multimodal Cardiac Interoceptive Deficits

“…To bridge this gap, we implemented a machine learning framework to evaluate whether different markers of cardiac interoception (cutting across behavioral, electrophysiological, and neuroimaging levels) successfully discriminate among neurological disorders (AD, bvFTD, MS, ST). Moreover, we included a contrastive cardiac condition (hypertensive disease ( 11 ), with expected cardiac interception deficits but with basic neuroanatomical preservation) ( 12 , 13 ) to disentangle the potential role of neurological versus autonomic disruptions in cardiac interoceptive impairments.…”

“…Here we assessed different cardiac interoceptive dimensions and levels of analysis in four neurological conditions (AD, bvFTD, MS, ST) relative to a cardiac condition ( 11 ) and controls. First, participants performed a validated HBD task ( 34 – 36 ) with ongoing electroencephalography (EEG) recordings to measure the HEP.…”