Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03226743 |
Other study ID # |
01GY1602 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 12, 2018 |
Est. completion date |
October 7, 2022 |
Study information
Verified date |
November 2022 |
Source |
Universitätsklinikum Hamburg-Eppendorf |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.