Depressive DisorderCOMETNCT03226743
Collaborative and Stepped Care in Mental Health (COMET)
A study testing collaborative and stepped care model in people with Depressive Disorder and Anxiety Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Anxiety Disorder, Somatoform Disorder
- What is being tested?
- collaborative and stepped care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jul 2018to 7 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers: A Cluster-randomized Controlled Trial (COMET)
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.
Read the 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.
- Being tested
- collaborative and stepped care model
- Keywords
- stepped and collaborative care, cluster-randomized controlled trial, health services research, evidence-based medicine, complex intervention, guideline implementation, collaborative network
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Somatoform Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collaborative and stepped care modelOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | collaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network Receives: Other: collaborative and stepped care model |
| Control Group | No intervention | treatment as usual in German health care system |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in health-related quality of life
measured with the Short Form Health Survey SF-36 mental health score
Measured: from baseline to 6 months and 12 and 24 months after baseline
Secondary outcomes (11)
change in disorder-specific symptoms: depression
measured on the major depressive module of the Patient Health Questionnaire PHQ: PHQ-9
Measured: from baseline to 6 months and 12 and 24 months after baseline
change in disorder-specific symptoms: panic
measured on the panic module of the Patient Health Questionnaire PHQ: PHQ-panic module
Measured: from baseline to 6 months and 12 and 24 months after baseline
change in disorder-specific symptoms: generalized anxiety
measured on the generalized anxiety module of the Patient Health Questionnaire PHQ: GAD-7
Measured: from baseline to 6 months and 12 months and 24 months after baseline
change in disorder-specific symptoms: somatoform syndrome PHQ
measured on the somatoform module of the Patient Health Questionnaire PHQ: PHQ-15
Measured: from baseline to 6 months and 12 and 24 months after baseline
change in disorder-specific symptoms: somatoform syndrome SSD-12
measured on the Somatic Symptom Disorder-B SSD-12
Measured: from baseline to 6 months and 12 and 24 months after baseline
change in disorder-specific symptoms: alcohol abuse disorder
measured on the Alcohol Use Disorders Identification Test: AUDIT
Measured: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: direct costs
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.
Measured: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: indirect costs
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.
Measured: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: health effects
quality-adjusted life years (QALYs) will be calculated based on utilities derived from the EQ-5D-5L questionnaire
Measured: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: incremental cost-effectiveness
incremental cost-effectiveness ratios (ICER) will be calculated
Measured: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: acceptability
Cost-effectiveness acceptability curves (CEAC) will be calculated.
Measured: from baseline to 6 months and 12 and 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start12 Jul 2018
- Primary completion12 Apr 2021
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Care Research Hamburg, Hamburg Center for Health Economics
- Responsible party
- Principal investigator, Prof. Dr. Martin Härter, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Martin Härter, Prof. Dr. Dr., Principal investigator, Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226743
- Sponsor's protocol ID
- 01GY1602
- Acronym
- COMET
- Status last verified
- Dec 2024
- First submitted
- 10 Jul 2017
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41083989Heddaeus D, Seeralan T, Maehder K, Porzelt S, Daubmann A, Dams J, Grochtdreis T, Konig HH, von dem Knesebeck O, Lowe B, Pepic A, Rosenkranz M, Schafer I, Zimmermann T, Schulte B, Weigel A, Wegscheider K, Werner S, Zapf A, Scherer M, Dirmaier J, Harter M. Collaborative and Stepped Care for Mental Disorders: Results of a Cluster-Randomized Controlled Trial in Outpatient Care (The COMET Study). Dtsch Arztebl Int. 2025 Mar 7;122(5):127-134. doi: 10.3238/arztebl.m2025.0011.
PubMed 39908421Maehder 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.
PubMed 34098913Weigel 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.
PubMed 32896756Maehder 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.
PubMed 32023303Heddaeus 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.
PubMed 31767595Maehder 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.
PubMed 30535053
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers: A Cluster-randomized Controlled Trial (COMET)
- ClinicalTrials.gov ID
- NCT03226743
- Acronym / sponsor ID
- COMET / 01GY1602
- Keywords
- stepped and collaborative care, cluster-randomized controlled trial, health services research, evidence-based medicine, complex intervention, guideline implementation, collaborative network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Center for Health Care Research Hamburg, Hamburg Center for Health Economics
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: collaborative and stepped care modelcollaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network |
| Control Group | No intervention | –treatment as usual in German health care system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collaborative and stepped care modelIncluding 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 | Other | Intervention Group |
Primary outcome
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
11 secondary outcomes
change in disorder-specific symptoms: depression
Time frame: 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
change in disorder-specific symptoms: generalized anxiety
Time frame: 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
change in disorder-specific symptoms: somatoform syndrome SSD-12
Time frame: from baseline to 6 months and 12 and 24 months after baseline
change in disorder-specific symptoms: alcohol abuse disorder
Time frame: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: direct costs
Time frame: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: indirect costs
Time frame: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: health effects
Time frame: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: incremental cost-effectiveness
Time frame: from baseline to 6 months and 12 and 24 months after baseline
cost effectiveness: acceptability
Time frame: from baseline to 6 months and 12 and 24 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 41083989Grochtdreis 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.
- Derived from this study: PubMed 39908421Heddaeus D, Seeralan T, Maehder K, Porzelt S, Daubmann A, Dams J, Grochtdreis T, Konig HH, von dem Knesebeck O, Lowe B, Pepic A, Rosenkranz M, Schafer I, Zimmermann T, Schulte B, Weigel A, Wegscheider K, Werner S, Zapf A, Scherer M, Dirmaier J, Harter M. Collaborative and Stepped Care for Mental Disorders: Results of a Cluster-Randomized Controlled Trial in Outpatient Care (The COMET Study). Dtsch Arztebl Int. 2025 Mar 7;122(5):127-134. doi: 10.3238/arztebl.m2025.0011.
- Derived from this study: PubMed 34098913Maehder 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.
- Derived from this study: PubMed 32896756Weigel 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.
- Derived from this study: PubMed 32023303Maehder 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.
- Derived from this study: PubMed 31767595Heddaeus 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.
- Derived from this study: PubMed 30535053Maehder 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Härter, Prof. Dr. Dr. principal investigator
Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collaborative and stepped care model in people with Depressive Disorder and Anxiety Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in health-related quality of life (time frame: from baseline to 6 months and 12 and 24 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226743, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.