Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression
- Conditions
- Depression
- Interventions
- Behavioral: Active monitoringBehavioral: BibliotherapyBehavioral: Online self-helpBehavioral: Outpatient psychotherapyProcedure: Psychiatric treatmentBehavioral: Combined psychotherapy and psychopharmacological treatment
- 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
- >4 points on PHQ-D-9 depression scale
- sufficient knowledge of German language
- health situation that allows questionnaire completion
- insufficient knowledge of German language
- health situation not allowing questionnaire completion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stepped care intervention (SCM) Active monitoring Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: \>4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting. Stepped care intervention (SCM) Outpatient psychotherapy Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: \>4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting. Stepped care intervention (SCM) Combined psychotherapy and psychopharmacological treatment Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: \>4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting. Stepped care intervention (SCM) Online self-help Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: \>4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting. Stepped care intervention (SCM) Bibliotherapy Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: \>4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting. Stepped care intervention (SCM) Psychiatric treatment Patients within the stepped care intervention are screened by general physician using the PHQ-9 (inclusion criterion: \>4 points) and diagnosed according to International Classification of Diseases (ICD-10) criteria. Patients receive differentially intensive treatment according to depression severity. Patients with mild depression receive: Step I: Active monitoring or Step II: II.a. Bibliotherapy or II.b. Online self-help ("Deprexis®") or II+: Telephone-based psychotherapy Patients with moderate depression receive: Step III: III.a. Outpatient psychotherapy or III.b. Psychopharmacological treatment Patients with severe depression receive: Step IV: Combined psychotherapy and psychopharmacological treatment, optionally in inpatient setting.
- 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