Depression
Conditions
Keywords
depression, stepped care, evidence-based medicine, health services research, psychotherapy, complex intervention, guideline
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.
Interventions
BEHAVIORALActive monitoring
General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
BEHAVIORALBibliotherapy
Patient works with self-help book Selbsthilfe bei Depressionen (Görlitz, 2010) under general physician's supervision.
BEHAVIORALOnline self-help
Patient works with online self-help program Deprexis under general physician's supervision.
BEHAVIORALOutpatient psychotherapy
Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
PROCEDUREPsychiatric 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.
BEHAVIORALCombined psychotherapy and psychopharmacological treatment
Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
OTHERControl group: treatment as usual
treatment as usual
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Quality of life (EQ-5D) | Baseline, 3 months, 6 months, 12 months | Quality of life as measured by EuroQol's EQ-5D |
| 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) |
| Anxiety symptoms (PHQ-D) | Baseline, 3 months, 6 months, 12 months | Anxiety as rated by the PHQ-D anxiety scale |
| Panic symptoms (PHQ-D) | Baseline, 3 months, 6 months, 12 months | Panic symptoms as measured by the PHQ-D |
| Somatisation (PHQ-D) | Baseline, 3 months, 6 months, 12 months | Somatisation as measured by the PHQ-D |
| General anxiety disorder (GAD-7) | Baseline, 3 months, 6 months, 12 months | Symptoms of general anxiety disorder measured by the GAD-7 |
| Therapeutic alliance | Baseline, 3 months, 6 months, 12 months | Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ) |
Countries
Germany
Outcome results
None listed