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

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT01731717
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-22
• Primary Completion: 2015-03
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 737

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in depression severity (PHQ-D-9)	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 Outcome Measures

Name	Time	Method
Quality of life (SF-12)	Baseline, 3 months, 6 months, 9 months	Quality of life as measured by the 12-item Short Form Health Survey (SF-12)
Health service utilization and medication consumption	Baseline, 6 months, 12 months	Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
Self-esteem	Baseline, 3 months, 6 months, 12 months	Rosenberg self-esteem scale
Cost-benefit ratio (QALYs)	Baseline, 6 months, 12 months	Cost-benefit ratio in quality-adjusted life years(QALYs)
Response/Remission/Relapse (PHQ-D-9)	Baseline, 3 months, 6 months, 12 months	Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)
Therapeutic alliance	Baseline, 3 months, 6 months, 12 months	Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
Anxiety symptoms (PHQ-D)	Baseline, 3 months, 6 months, 12 months	Anxiety as rated by the PHQ-D anxiety scale
Somatisation (PHQ-D)	Baseline, 3 months, 6 months, 12 months	Somatisation as measured by the PHQ-D
Panic symptoms (PHQ-D)	Baseline, 3 months, 6 months, 12 months	Panic symptoms as measured by the PHQ-D
Quality of life (EQ-5D)	Baseline, 3 months, 6 months, 12 months	Quality of life as measured by EuroQol's EQ-5D
General anxiety disorder (GAD-7)	Baseline, 3 months, 6 months, 12 months	Symptoms of general anxiety disorder measured by the GAD-7

Trial Locations

Locations (1)

Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany