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Collaborative and Stepped Care in Mental Health (COMET) (COMET)

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ClinicalTrials.gov Identifier: NCT03226743
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : March 12, 2021
Sponsor:
Collaborators:
Center for Health Care Research Hamburg
Hamburg Center for Health Economics
Information provided by (Responsible Party):
Prof. Dr. Martin Härter, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
The aims of COMET are the implementation and evaluation of effectiveness and cost-effectiveness as well as processes of a collaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network in comparison to routine care. In a cluster-randomized controlled effectiveness trial 570 patients will be recruited by 38 general practitioner practices and followed with a prospective survey at four time points. The primary outcome is the change in health-related quality of life from baseline to 6-months follow-up. Secondary outcomes include disorder-specific symptom burden, response, remission, functional quality of life, cost-effectiveness, evaluation of processes and other clinical and psychosocial variables.

Condition or disease Intervention/treatment Phase
Depressive Disorder Anxiety Disorder Somatoform Disorder Alcohol Use Disorder Other: collaborative and stepped care model Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

No Intervention: Control Group
treatment as usual in German health care system



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Martin Härter, Prof. Dr. Dr. +49 40 7410 52863 m.haerter@uke.de
Contact: Daniela Heddaeus, Dr. Dipl. Psych. +49 40 7410 57558 d.heddaeus@uke.de

Locations
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Germany
University Medical Center Hamburg Recruiting
Hamburg, Germany, 20252
Contact: Martin Haerter, Prof. Dr. Dr.    040 7410 52863    m.haerter@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Center for Health Care Research Hamburg
Hamburg Center for Health Economics
Investigators
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Principal Investigator: Martin Härter, Prof. Dr. Dr. Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Prof. Dr. Martin Härter, Prof. Dr. med Dr. phil. Dipl. Psych., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03226743    
Other Study ID Numbers: 01GY1602
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Martin Härter, Universitätsklinikum Hamburg-Eppendorf:
stepped and collaborative care
cluster-randomized controlled trial
health services research
evidence-based medicine
complex intervention
guideline implementation
collaborative network
Additional relevant MeSH terms:
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Disease
Alcoholism
Depressive Disorder
Anxiety Disorders
Somatoform Disorders
Pathologic Processes
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders