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

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Depression

Treatments: Behavioral: Bibliotherapy; Behavioral: Online self-help; Other: Control group: treatment as usual; Behavioral: Outpatient psychotherapy; Procedure: Psychiatric treatment; Behavioral: Active monitoring; Behavioral: Combined psychotherapy and psychopharmacological treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01731717

01KQ1002B-TP7

Details and patient eligibility

About

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.

Enrollment: 737 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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737 participants in 2 patient groups

Stepped care intervention (SCM)

Experimental group

Description:

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.

Treatment:

Behavioral: Active monitoring

Behavioral: Combined psychotherapy and psychopharmacological treatment

Behavioral: Outpatient psychotherapy

Procedure: Psychiatric treatment

Behavioral: Bibliotherapy

Behavioral: Online self-help

Control group: treatment as usual

Active Comparator group

Description:

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.

Treatment:

Other: Control group: treatment as usual