Collaborative and Stepped Care in Mental Health (COMET)
NCT ID: NCT03226743
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
615 participants
INTERVENTIONAL
2018-07-12
2022-10-07
Brief Summary
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Detailed Description
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Its novelty is the integration of these four disorders into one model. This approach is based on a) the high comorbidity between these disorders, b) the fact that they share a common etiological and diag-nostic basis, c) that similar evidence-based treatment options exist for them (e.g., self-help and psychoeducation, psychotherapy, pharmacotherapy), and d) that health care providers need to manage them together very often.
The conceptual basis follows the principles of evidence-based medicine with a specific focus on guideline implementation and the principles of patient-centered care including access, coordination and continuity of care, patient information, patient involvement and empowerment. Based on a multi-professional cooperation of health care providers across different care sectors an integrated health care network consisting of general practitioners (GPs), mental health specialists (psychiatrists, psychotherapists) and inpatient facilities will be established. Evidence-based clinical practice guidelines and pathways of care with treatment options of varying intensity form the clinical and procedural basis of the network, including low-intensity treatments and e-mental health technologies.
The study is planned as a randomized controlled effectiveness trial of a consecutive sample of patients with depressive and/or anxiety and/or somatoform and/or alcohol abuse disorders drawn from primary care (GP practices) and followed with a prospective survey at four time points. The study is intended to recruit a total of 570 patients from 38 GP practices. A cluster-randomization at the level of participating GP practices divides GPs into the intervention group, where patients are treated within a multi-professional collaborative and stepped care approach (including low-intensity treatments, direct access to mental health specialists, inpatient care etc., COMET), and the control group, where patients receive standard care (treatment as usual, TAU). Data collection is carried out with questionnaires as well as telephone interviews at four time-standardized measurement points within one year (baseline, 3, 6, 12 and 24 months). Additionally, independent research assistants perform standardized diagnostic interviews (CIDI) with patients at baseline to allow an assessment of diagnostic validity.
The main research hypothesis is that the COMET model is more effective than TAU. Primary outcome is the change in health-related quality of life measured by the SF-36 mental health score from baseline to 6-months follow-up. Secondary outcomes include symptom burden of depressive, generalized anxiety, panic, somatoform and alcohol abuse syndromes (PHQ-9; GAD-7; PHQ-15; PHQ panic and alcohol abuse syndrome module; SSD-12), disorder-specific response and remission, functional quality of life (EQ-5D-5L), duration of untreated illness, and other clinical and psychosocial variables (outcome evaluation, Work Package 1). Furthermore, direct and indirect costs and the incremental cost-effectiveness ratio will be assessed (economic evaluation, Work Package 2). Finally, feasibility and acceptance of the COMET model as well as of the different treatment components are assessed, including the implementation process (process evaluation, Work Package 3). To this end, semi-structured interviews will be conducted at two measurement points, supplemented by standardized surveys among involved patients and providers.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
collaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network
collaborative and stepped care model
Including elements:
* collaborative and stepped care of patients with mental disorders
* treatment in a multiprofessional network consisting of primary care physicians, psychologists, psychiatrists and inpatient facilities
* initial training of participating health care providers
* formalized and standardized screening procedure for early recognition of depressive, anxiety, somatoform and alcohol abuse disorders
* formalized ICD-diagnostics
* guideline-oriented treatment recommendations
* bibliotherapy or internet-based self-help for patient with mild to moderate disorders
* online referral platform
* case management for patients with severe disorders
* systematic and regular monitoring
* regular quality circles for participating health care providers
Control Group
treatment as usual in German health care system
No interventions assigned to this group
Interventions
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collaborative and stepped care model
Including elements:
* collaborative and stepped care of patients with mental disorders
* treatment in a multiprofessional network consisting of primary care physicians, psychologists, psychiatrists and inpatient facilities
* initial training of participating health care providers
* formalized and standardized screening procedure for early recognition of depressive, anxiety, somatoform and alcohol abuse disorders
* formalized ICD-diagnostics
* guideline-oriented treatment recommendations
* bibliotherapy or internet-based self-help for patient with mild to moderate disorders
* online referral platform
* case management for patients with severe disorders
* systematic and regular monitoring
* regular quality circles for participating health care providers
Eligibility Criteria
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Exclusion Criteria
18 Years
ALL
No
Sponsors
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Center for Health Care Research Hamburg
UNKNOWN
Hamburg Center for Health Economics
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Prof. Dr. Martin Härter
Prof. Dr. med Dr. phil. Dipl. Psych.
Principal Investigators
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Martin Härter, Prof. Dr. Dr.
Role: PRINCIPAL_INVESTIGATOR
Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Locations
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University Medical Center Hamburg
Hamburg, , Germany
Countries
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References
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Grochtdreis T, Heddaeus D, Seeralan T, Maehder K, Porzelt S, Daubmann A, Pepic A, Lowe B, Rosenkranz M, Schafer I, Scherer M, Schulte B, von dem Knesebeck O, Weigel A, Wegscheider K, Werner S, Zapf A, Zimmermann T, Dirmaier J, Harter M, Konig HH, Dams J. Cost-utility analysis of a collaborative and stepped care model in patients with mental disorders in German primary care (the COMET study). BMC Psychiatry. 2025 Oct 13;25(1):973. doi: 10.1186/s12888-025-07428-5.
Maehder K, Werner S, Weigel A, Lowe B, Heddaeus D, Harter M, von dem Knesebeck O. How do care providers evaluate collaboration? - qualitative process evaluation of a cluster-randomized controlled trial of collaborative and stepped care for patients with mental disorders. BMC Psychiatry. 2021 Jun 8;21(1):296. doi: 10.1186/s12888-021-03274-3.
Weigel A, Maehder K, Witt M, Lowe B. Psychotherapists' perspective on the treatment of patients with somatic symptom disorders. J Psychosom Res. 2020 Nov;138:110228. doi: 10.1016/j.jpsychores.2020.110228. Epub 2020 Aug 29.
Maehder K, Lowe B, Harter M, Heddaeus D, von dem Knesebeck O, Weigel A. Psychotherapists' perspectives on collaboration and stepped care in outpatient psychotherapy-A qualitative study. PLoS One. 2020 Feb 5;15(2):e0228748. doi: 10.1371/journal.pone.0228748. eCollection 2020.
Heddaeus D, Dirmaier J, Brettschneider C, Daubmann A, Grochtdreis T, von dem Knesebeck O, Konig HH, Lowe B, Maehder K, Porzelt S, Rosenkranz M, Schafer I, Scherer M, Schulte B, Wegscheider K, Weigel A, Werner S, Zimmermann T, Harter M. 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. BMJ Open. 2019 Nov 24;9(11):e032408. doi: 10.1136/bmjopen-2019-032408.
Maehder K, Lowe B, Harter M, Heddaeus D, Scherer M, Weigel A. Management of comorbid mental and somatic disorders in stepped care approaches in primary care: a systematic review. Fam Pract. 2019 Jan 25;36(1):38-52. doi: 10.1093/fampra/cmy122.
Other Identifiers
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01GY1602
Identifier Type: -
Identifier Source: org_study_id