Clinical trial NCT01731717: Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression
Official title: Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
stepped care
evidence-based medicine
health services research
psychotherapy
complex intervention
guideline
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in depression severity (PHQ-D-9)
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Cost-benefit ratio (QALYs)
timeFrame: Baseline, 6 months, 12 months
measure: Response/Remission/Relapse (PHQ-D-9)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Quality of life (EQ-5D)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Quality of life (SF-12)
timeFrame: Baseline, 3 months, 6 months, 9 months
measure: Health service utilization and medication consumption
timeFrame: Baseline, 6 months, 12 months
measure: Self-esteem
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Therapeutic alliance
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Anxiety symptoms (PHQ-D)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Panic symptoms (PHQ-D)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Somatisation (PHQ-D)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: General anxiety disorder (GAD-7)
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf
Study officials:
affiliation: Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
name: Birgit Watzke, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
name: Martin Härter, Prof. Dr. Dr.
role: STUDY_DIRECTOR
References:
citation: Brettschneider C, Heddaeus D, Steinmann M, Harter M, Watzke B, Konig HH. Cost-effectiveness of guideline-based stepped and collaborative care versus treatment as usual for patients with depression - a cluster-randomized trial. BMC Psychiatry. 2020 Aug 28;20(1):427. doi: 10.1186/s12888-020-02829-0.
citation: Watzke B, Heddaeus D, Steinmann M, Konig HH, Wegscheider K, Schulz H, Harter M. Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care. BMC Psychiatry. 2014 Aug 20;14:230. doi: 10.1186/s12888-014-0230-y.