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Clinical Trials/NCT01731717
NCT01731717
Completed
N/A

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country737 target enrollmentSeptember 2012
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
737
Locations
1
Primary Endpoint
Change in depression severity (PHQ-D-9)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

PD Dr. phil. Birgit Watzke

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

Eligibility Criteria

Inclusion Criteria

  • \>4 points on PHQ-D-9 depression scale
  • sufficient knowledge of German language
  • health situation that allows questionnaire completion

Exclusion Criteria

  • insufficient knowledge of German language
  • health situation not allowing questionnaire completion

Outcomes

Primary Outcomes

Change in depression severity (PHQ-D-9)

Time Frame: Baseline, 3 months, 6 months, 12 months

Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel \& Herzog, 2002)

Secondary Outcomes

  • Quality of life (SF-12)(Baseline, 3 months, 6 months, 9 months)
  • Health service utilization and medication consumption(Baseline, 6 months, 12 months)
  • Self-esteem(Baseline, 3 months, 6 months, 12 months)
  • Cost-benefit ratio (QALYs)(Baseline, 6 months, 12 months)
  • Response/Remission/Relapse (PHQ-D-9)(Baseline, 3 months, 6 months, 12 months)
  • Therapeutic alliance(Baseline, 3 months, 6 months, 12 months)
  • Anxiety symptoms (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
  • Somatisation (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
  • Panic symptoms (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
  • Quality of life (EQ-5D)(Baseline, 3 months, 6 months, 12 months)
  • General anxiety disorder (GAD-7)(Baseline, 3 months, 6 months, 12 months)

Study Sites (1)

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