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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

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
NameTimeMethod
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
NameTimeMethod
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 consumptionBaseline, 6 months, 12 months

Non-standardized items regarding the amount and cost of health services utilized in the past 6 months

Self-esteemBaseline, 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 allianceBaseline, 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

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

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