NCT03226743: COMET

Collaborative and Stepped Care in Mental Health (COMET)

Completed NA Last updated 9 December 2024

What this trial tests

NA trial testing collaborative and stepped care model in Depressive Disorder in 615 participants. Completed in 7 October 2022.

Timeline

12 July 2018

Primary endpoint
12 April 2021

7 October 2022

Quick facts

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	615
Start date	12 July 2018
Primary completion	12 April 2021
Estimated completion	7 October 2022
Sites	1 location across Germany

Drugs / interventions tested

• collaborative and stepped care model

Conditions studied

• Depressive Disorder — all drugs for Depressive Disorder →
• Anxiety Disorder — all drugs for Anxiety Disorder →
• Somatoform Disorder — all drugs for Somatoform Disorder →
• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

18 and older, any sex, with Depressive Disorder or Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Management of comorbid mental and somatic disorders in stepped care approaches in primary care: a systematic review.
   Maehder K, Löwe B, Härter M, Heddaeus D, et al · · 2019 · cited 17× · PMID 30535053 · DOI 10.1093/fampra/cmy122
2. 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.
   Heddaeus D, Dirmaier J, Brettschneider C, Daubmann A, et al · · 2019 · cited 10× · PMID 31767595 · DOI 10.1136/bmjopen-2019-032408
3. Psychotherapists' perspective on the treatment of patients with somatic symptom disorders.
   Weigel A, Maehder K, Witt M, Löwe B. · · 2020 · cited 9× · PMID 32896756 · DOI 10.1016/j.jpsychores.2020.110228
4. Psychotherapists' perspectives on collaboration and stepped care in outpatient psychotherapy-A qualitative study.
   Maehder K, Löwe B, Härter M, Heddaeus D, et al · · 2020 · cited 8× · PMID 32023303 · DOI 10.1371/journal.pone.0228748
5. 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.
   Maehder K, Werner S, Weigel A, Löwe B, et al · · 2021 · cited 6× · PMID 34098913 · DOI 10.1186/s12888-021-03274-3
6. Collaborative and Stepped Care for Mental Disorders: Results of a Cluster-Randomized Controlled Trial in Outpatient Care (The COMET Study).
   Heddaeus D, Seeralan T, Maehder K, Porzelt S, et al · · 2025 · cited 1× · PMID 39908421 · DOI 10.3238/arztebl.m2025.0011
7. Cost-utility analysis of a collaborative and stepped care model in patients with mental disorders in German primary care (the COMET study).
   Grochtdreis T, Heddaeus D, Seeralan T, Maehder K, et al · · 2025 · PMID 41083989 · DOI 10.1186/s12888-025-07428-5