- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226743
Collaborative and Stepped Care in Mental Health (COMET) (COMET)
Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers: A Cluster-randomized Controlled Trial (COMET)
Study Overview
Status
Intervention / Treatment
Detailed Description
Aims are a) the implementation and outcome evaluation, b) the process evaluation, and c) the analysis of the cost-effectiveness of an innovative collaborative and stepped care model for patients with depressive, anxiety, somatoform and/or alcohol abuse disorders.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hamburg, Germany, 20252
- University Medical Center Hamburg
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria are a minimum age of 18, informed consent and one or more of the following positive ICD-10-diagnoses: depressive episode (F32), recurrent depressive disorder (F33), dysthymia (F34.1), agoraphobia (F40.0), social phobia (F40.1), panic disorder (F41.0), generalized anxiety disorder (F41.1), mixed anxiety and depressive disorder (F41.2), somatoform disorders (F45), and/or mental and behavioral disorders due to use of alcohol (F10.1, F.10.2)
Exclusion Criteria:
- Patients with insufficient knowledge of the German language, an acute psychosis or a health situation that does not allow questionnaire completion or patients already receiving current in- or outpatient psychiatric or psychotherapeutic care are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention Group
collaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network
|
Including elements:
|
NO_INTERVENTION: Control Group
treatment as usual in German health care system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in health-related quality of life
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
measured with the Short Form Health Survey SF-36 mental health score
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from baseline to 6 months and 12 and 24 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in disorder-specific symptoms: depression
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
measured on the major depressive module of the Patient Health Questionnaire PHQ: PHQ-9
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from baseline to 6 months and 12 and 24 months after baseline
|
change in disorder-specific symptoms: panic
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
measured on the panic module of the Patient Health Questionnaire PHQ: PHQ-panic module
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from baseline to 6 months and 12 and 24 months after baseline
|
change in disorder-specific symptoms: generalized anxiety
Time Frame: from baseline to 6 months and 12 months and 24 months after baseline
|
measured on the generalized anxiety module of the Patient Health Questionnaire PHQ: GAD-7
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from baseline to 6 months and 12 months and 24 months after baseline
|
change in disorder-specific symptoms: somatoform syndrome PHQ
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
measured on the somatoform module of the Patient Health Questionnaire PHQ: PHQ-15
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from baseline to 6 months and 12 and 24 months after baseline
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change in disorder-specific symptoms: somatoform syndrome SSD-12
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
measured on the Somatic Symptom Disorder-B SSD-12
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from baseline to 6 months and 12 and 24 months after baseline
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change in disorder-specific symptoms: alcohol abuse disorder
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
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measured on the Alcohol Use Disorders Identification Test: AUDIT
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from baseline to 6 months and 12 and 24 months after baseline
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cost effectiveness: direct costs
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
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will be assessed based on health care utilization, reduced productivity at work and work loss days measured by a modified version the Client Sociodemographic and Service Receipt Inventory (CSSRI).
For the monetary valuation of resources, unit costs will be applied.
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from baseline to 6 months and 12 and 24 months after baseline
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cost effectiveness: indirect costs
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
will be assessed based on health care utilization, reduced productivity at work and work loss days measured by a modified version the Client Sociodemographic and Service Receipt Inventory (CSSRI).
Indirect costs will be calculated based on the human capital approach.
|
from baseline to 6 months and 12 and 24 months after baseline
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cost effectiveness: health effects
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
|
quality-adjusted life years (QALYs) will be calculated based on utilities derived from the EQ-5D-5L questionnaire
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from baseline to 6 months and 12 and 24 months after baseline
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cost effectiveness: incremental cost-effectiveness
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
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incremental cost-effectiveness ratios (ICER) will be calculated
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from baseline to 6 months and 12 and 24 months after baseline
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cost effectiveness: acceptability
Time Frame: from baseline to 6 months and 12 and 24 months after baseline
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Cost-effectiveness acceptability curves (CEAC) will be calculated.
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from baseline to 6 months and 12 and 24 months after baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Martin Härter, Prof. Dr. Dr., Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GY1602
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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