Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 737
- Locations
- 1
- Primary Endpoint
- Change in depression severity (PHQ-D-9)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Stepped care intervention (SCM)
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.
Intervention: Active monitoring (Behavioral)
Stepped care intervention (SCM)
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.
Intervention: Bibliotherapy (Behavioral)
Stepped care intervention (SCM)
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.
Intervention: Online self-help (Behavioral)
Stepped care intervention (SCM)
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.
Intervention: Outpatient psychotherapy (Behavioral)
Stepped care intervention (SCM)
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.
Intervention: Psychiatric treatment (Procedure)
Stepped care intervention (SCM)
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.
Intervention: Combined psychotherapy and psychopharmacological treatment (Behavioral)
Control group: treatment as usual
Patients in the control group are screened by their general physician using the PHQ-D-9 depression scale. Patients included in the study then receive treatment as usual from general physician or other health service providers.
Intervention: Control group: treatment as usual (Other)
Outcomes
Primary Outcomes
Change in depression severity (PHQ-D-9)
Time Frame: 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 Outcomes
- Quality of life (SF-12)(Baseline, 3 months, 6 months, 9 months)
- Health service utilization and medication consumption(Baseline, 6 months, 12 months)
- Self-esteem(Baseline, 3 months, 6 months, 12 months)
- Cost-benefit ratio (QALYs)(Baseline, 6 months, 12 months)
- Response/Remission/Relapse (PHQ-D-9)(Baseline, 3 months, 6 months, 12 months)
- Therapeutic alliance(Baseline, 3 months, 6 months, 12 months)
- Anxiety symptoms (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
- Somatisation (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
- Panic symptoms (PHQ-D)(Baseline, 3 months, 6 months, 12 months)
- Quality of life (EQ-5D)(Baseline, 3 months, 6 months, 12 months)
- General anxiety disorder (GAD-7)(Baseline, 3 months, 6 months, 12 months)
Investigators
PD Dr. phil. Birgit Watzke
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf