Cluster Randomized Trial of Stepped Care Intervention vs. Treatment as Usual for Patients With Depression (SCM)
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|ClinicalTrials.gov Identifier: NCT01731717|
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : July 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Active monitoring Behavioral: Bibliotherapy Behavioral: Online self-help Behavioral: Outpatient psychotherapy Procedure: Psychiatric treatment Behavioral: Combined psychotherapy and psychopharmacological treatment Other: Control group: treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||737 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||May 2015|
Experimental: 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.
Behavioral: Active monitoring
General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
Patient works with self-help book "Selbsthilfe bei Depressionen" (Görlitz, 2010) under general physician's supervision.
Behavioral: Online self-help
Patient works with online self-help program "Deprexis" under general physician's supervision.
Behavioral: Outpatient psychotherapy
Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
Procedure: 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.
Behavioral: Combined psychotherapy and psychopharmacological treatment
Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
Active Comparator: 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.
Other: Control group: treatment as usual
treatment as usual
- 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)
- Cost-benefit ratio (QALYs) [ Time Frame: Baseline, 6 months, 12 months ]Cost-benefit ratio in quality-adjusted life years(QALYs)
- Response/Remission/Relapse (PHQ-D-9) [ Time Frame: 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) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Quality of life as measured by EuroQol's EQ-5D
- Quality of life (SF-12) [ Time Frame: 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 [ Time Frame: Baseline, 6 months, 12 months ]Non-standardized items regarding the amount and cost of health services utilized in the past 6 months
- Self-esteem [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Rosenberg self-esteem scale
- Therapeutic alliance [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
- Anxiety symptoms (PHQ-D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Anxiety as rated by the PHQ-D anxiety scale
- Panic symptoms (PHQ-D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Panic symptoms as measured by the PHQ-D
- Somatisation (PHQ-D) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Somatisation as measured by the PHQ-D
- General anxiety disorder (GAD-7) [ Time Frame: Baseline, 3 months, 6 months, 12 months ]Symptoms of general anxiety disorder measured by the GAD-7
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731717
|Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Study Director:||Birgit Watzke, Prof. Dr.||Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany|
|Study Director:||Martin Härter, Prof. Dr. Dr.||Centre for Psychosocial Medicine, Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany|