Collaborative and Stepped Care in Mental Health (COMET)

NCT03226743 | Completed

• 1 other identifier: 01GY1602
• Study Type: interventional
• Target: 615
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Anxiety Disorder; Somatoform Disorder; Alcohol Use Disorder

Keywords

stepped and collaborative care; cluster-randomized controlled trial; health services research; evidence-based medicine; complex intervention; guideline implementation; collaborative network

Outcome Measures

Primary Outcomes (1)

• change in health-related quality of life

  measured with the Short Form Health Survey SF-36 mental health score

  from baseline to 6 months and 12 and 24 months after baseline

Secondary Outcomes (11)

• change in disorder-specific symptoms: depression

  from baseline to 6 months and 12 and 24 months after baseline

• change in disorder-specific symptoms: panic

  from baseline to 6 months and 12 and 24 months after baseline

• change in disorder-specific symptoms: generalized anxiety

  from baseline to 6 months and 12 months and 24 months after baseline

• change in disorder-specific symptoms: somatoform syndrome PHQ

  from baseline to 6 months and 12 and 24 months after baseline

• change in disorder-specific symptoms: somatoform syndrome SSD-12

  from baseline to 6 months and 12 and 24 months after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

collaborative and stepped care model for depressive, anxiety, somatoform and/or alcohol abuse disorders within a multiprofessional network

Other: collaborative and stepped care model

Control Group

NO INTERVENTION

treatment as usual in German health care system

Interventions

collaborative and stepped care model OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Center for Health Care Research Hamburg: collaborator
• Hamburg Center for Health Economics: collaborator

Study Sites (1)

University Medical Center Hamburg

Hamburg, 20252, Germany

Location

Related Publications (6)

• 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.

  PMID: 41083989 DERIVED

• Maehder 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.

  PMID: 34098913 DERIVED

• Weigel 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.

  PMID: 32896756 DERIVED

• Maehder 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.

  PMID: 32023303 DERIVED

• Heddaeus 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.

  PMID: 31767595 DERIVED

• Maehder 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.

  PMID: 30535053 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Somatoform Disorders; Alcoholism

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Martin Härter, Prof. Dr. Dr.

  Center for Psychosocial Medicine, Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med Dr. phil. Dipl. Psych.

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 24, 2017
• Study Start: July 12, 2018
• Primary Completion: April 12, 2021
• Study Completion: October 7, 2022
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

DE (1)