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Completed NA INTERVENTIONAL NCT01731717

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Active monitoring
Type: BEHAVIORAL
Description: General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
Name: Bibliotherapy
Type: BEHAVIORAL
Description: Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
Name: Online self-help
Type: BEHAVIORAL
Description: Patient works with online self-help program "Deprexis" under general physician's supervision.
Name: Outpatient psychotherapy
Type: BEHAVIORAL
Description: Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
Name: Psychiatric treatment
Type: PROCEDURE
Description: 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.
Name: Combined psychotherapy and psychopharmacological treatment
Type: BEHAVIORAL
Description: Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
Name: Control group: treatment as usual
Type: OTHER
Description: treatment as usual

Primary Outcomes

Measure: Change in depression severity (PHQ-D-9)
TimeFrame: Baseline, 3 months, 6 months, 12 months
Description: Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel \& Herzog, 2002)

Trial Information

NCT ID

NCT01731717

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

UniversitÀtsklinikum Hamburg-Eppendorf

Last Updated

December 15, 2025