Collaborative and Stepped Care in Mental Health (COMET) (COMET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03226743|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : March 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder Anxiety Disorder Somatoform Disorder Alcohol Use Disorder||Other: collaborative and stepped care model||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||570 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers: A Cluster-randomized Controlled Trial (COMET)|
|Actual Study Start Date :||July 12, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||January 2023|
Experimental: Intervention Group
collaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network
Other: collaborative and stepped care model
No Intervention: Control Group
treatment as usual in German health care system
- 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
- 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
- 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
- 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
- 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
- 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
- change in disorder-specific symptoms: alcohol abuse disorder [ Time Frame: from baseline to 6 months and 12 and 24 months after baseline ]measured on the Alcohol Use Disorders Identification Test: AUDIT
- cost effectiveness: direct 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). For the monetary valuation of resources, unit costs will be applied.
- 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.
- 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
- cost effectiveness: incremental cost-effectiveness [ Time Frame: from baseline to 6 months and 12 and 24 months after baseline ]incremental cost-effectiveness ratios (ICER) will be calculated
- cost effectiveness: acceptability [ Time Frame: from baseline to 6 months and 12 and 24 months after baseline ]Cost-effectiveness acceptability curves (CEAC) will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226743
|Contact: Martin Härter, Prof. Dr. Dr.||+49 40 7410 email@example.com|
|Contact: Daniela Heddaeus, Dr. Dipl. Psych.||+49 40 7410 firstname.lastname@example.org|
|University Medical Center Hamburg||Recruiting|
|Hamburg, Germany, 20252|
|Contact: Martin Haerter, Prof. Dr. Dr. 040 7410 52863 email@example.com|
|Principal Investigator:||Martin Härter, Prof. Dr. Dr.||Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany|