NCT01731717

Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression

Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 737 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the project is the implementation and evaluation of a stepped care model (SCM) for patients with depression with 6 treatment options of varying intensity and setting, including innovative technologies (e-mental health, telephone-based psychotherapy). Within this complex intervention, patients are treated by a multiprofessional network of health care providers in Hamburg, Germany. The study compares the SCM condition (intervention group) to a control group receiving treatment as usual (cluster randomization on the level of participating general practitioners). It is expected that the SCM condition will show better results regarding reduction of mental symptoms, improvement of quality of life, more efficient access to care and better cost-benefit ratio.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Active monitoring	General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
BEHAVIORAL	Bibliotherapy	Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
BEHAVIORAL	Online self-help	Patient works with online self-help program "Deprexis" under general physician's supervision.
BEHAVIORAL	Outpatient psychotherapy	Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
PROCEDURE	Psychiatric treatment	Patient receives treatment from psychiatrist or general physician participating in the network, this includes psychopharmacotherapy. Treatment takes place within routine care, thus psychiatrists or general physicians individually determine the type of medication and are committed to follow the recommendations of the German S3-Guideline/National Disease Management Guideline for Unipolar Depression.
BEHAVIORAL	Combined psychotherapy and psychopharmacological treatment	Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
OTHER	Control group: treatment as usual	treatment as usual

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-03-01
• Completion: 2015-05-01
• First posted: 2012-11-22
• Last updated: 2015-07-13

Locations

1 site across 1 country: Germany