Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression
NCT ID: NCT01731717
Last Updated: 2015-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
737 participants
INTERVENTIONAL
2012-09-30
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Active monitoring
General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
Bibliotherapy
Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
Online self-help
Patient works with online self-help program "Deprexis" under general physician's supervision.
Outpatient psychotherapy
Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
Psychiatric 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.
Combined psychotherapy and psychopharmacological treatment
Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
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.
Control group: treatment as usual
treatment as usual
Interventions
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Active monitoring
General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
Bibliotherapy
Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
Online self-help
Patient works with online self-help program "Deprexis" under general physician's supervision.
Outpatient psychotherapy
Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
Psychiatric 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.
Combined psychotherapy and psychopharmacological treatment
Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
Control group: treatment as usual
treatment as usual
Eligibility Criteria
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Inclusion Criteria
* sufficient knowledge of German language
* health situation that allows questionnaire completion
Exclusion Criteria
* health situation not allowing questionnaire completion
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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PD Dr. phil. Birgit Watzke
Principal Investigator
Principal Investigators
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Birgit Watzke, Prof. Dr.
Role: STUDY_DIRECTOR
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Martin Härter, Prof. Dr. Dr.
Role: STUDY_DIRECTOR
Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Locations
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Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Countries
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References
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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.
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.
Other Identifiers
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01KQ1002B-TP7
Identifier Type: -
Identifier Source: org_study_id
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