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

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

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Principal Investigators

• Birgit Watzke, Prof. Dr. · Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

• Martin Härter, Prof. Dr. Dr. · Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2015-03-31

Completion

2015-05-31

Countries

• Germany

Study Locations