CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 615 enrolled
Drug / intervention
collaborative and stepped care modelother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03226743
NCT03226743N/ACompleted

Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers: A Cluster-randomized Controlled Trial (COMET)

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Jul 24, 2017·Updated Dec 9, 2024

In Brief

A clinical study evaluating collaborative and stepped care model for Depressive Disorder and 3 related conditions. Completed, enrolled 615 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 24, 2017
Enrollment StartJul 12, 2018
Primary CompletionApr 12, 2021
Study CompletionOct 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.9 years ago

Interventions

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