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

Depression Clinical Trial

— SCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731717
• Other study ID #: 01KQ1002B-TP7
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: July 10, 2015
• Start date: September 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 737
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Active monitoring
General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
• Bibliotherapy
Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
• Online self-help
Patient works with online self-help program "Deprexis" under general physician's supervision.
• 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

Locations

Country	Name	City	State
Germany	Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression severity (PHQ-D-9)	Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002)	Baseline, 3 months, 6 months, 12 months	No
Secondary	Cost-benefit ratio (QALYs)	Cost-benefit ratio in quality-adjusted life years(QALYs)	Baseline, 6 months, 12 months	No
Secondary	Response/Remission/Relapse (PHQ-D-9)	Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9)	Baseline, 3 months, 6 months, 12 months	No
Secondary	Quality of life (EQ-5D)	Quality of life as measured by EuroQol's EQ-5D	Baseline, 3 months, 6 months, 12 months	No
Secondary	Quality of life (SF-12)	Quality of life as measured by the 12-item Short Form Health Survey (SF-12)	Baseline, 3 months, 6 months, 9 months	No
Secondary	Health service utilization and medication consumption	Non-standardized items regarding the amount and cost of health services utilized in the past 6 months	Baseline, 6 months, 12 months	No
Secondary	Self-esteem	Rosenberg self-esteem scale	Baseline, 3 months, 6 months, 12 months	No
Secondary	Therapeutic alliance	Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)	Baseline, 3 months, 6 months, 12 months	No
Secondary	Anxiety symptoms (PHQ-D)	Anxiety as rated by the PHQ-D anxiety scale	Baseline, 3 months, 6 months, 12 months	No
Secondary	Panic symptoms (PHQ-D)	Panic symptoms as measured by the PHQ-D	Baseline, 3 months, 6 months, 12 months	No
Secondary	Somatisation (PHQ-D)	Somatisation as measured by the PHQ-D	Baseline, 3 months, 6 months, 12 months	No
Secondary	General anxiety disorder (GAD-7)	Symptoms of general anxiety disorder measured by the GAD-7	Baseline, 3 months, 6 months, 12 months	No

External Links

•   Project homepage