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

Study Overview
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Brief Summary
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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.

Official Title
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Effektivität Und Effizienz Von Behandlungspfaden für Patienten Mit Depressiven Erkrankungen: Stepped Care Als Ansatz für Ein Leitliniengerechtes Und Integriertes Versorgungsmanagement

Conditions
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Depression

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped care intervention (SCM)<br>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<br>* General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.<br>Behavioral: Bibliotherapy<br>* Patient works with self-help book Selbsthilfe bei Depressionen (Görlitz, 2010) under general physician's supervision.<br>Behavioral: Online self-help<br>* Patient works with online self-help program Deprexis under general physician's supervision.<br>Behavioral: Outpatient psychotherapy<br>* Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.<br>Procedure: Psychiatric treatment<br>* 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.<br>Behavioral: Combined psychotherapy and psychopharmacological treatment<br>* Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.<br>|
| Active Comparator: Control group: treatment as usual<br>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<br>* treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression severity (PHQ-D-9) | Change in patient-rated depression symptom severity: Patient Health Questionnaire 9, German version (PHQ-D-9; Löwe, Zipfel & Herzog, 2002) | Baseline, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-benefit ratio (QALYs) | Cost-benefit ratio in quality-adjusted life years(QALYs) | Baseline, 6 months, 12 months | 
| Response/Remission/Relapse (PHQ-D-9) | Response/Remission/Relapse as computed by the difference in pre-post depression severity (PHQ-D-9) | Baseline, 3 months, 6 months, 12 months | 
| Quality of life (EQ-5D) | Quality of life as measured by EuroQol's EQ-5D | Baseline, 3 months, 6 months, 12 months | 
| Quality of life (SF-12) | Quality of life as measured by the 12-item Short Form Health Survey (SF-12) | Baseline, 3 months, 6 months, 9 months | 
| Health service utilization and medication consumption | Non-standardized items regarding the amount and cost of health services utilized in the past 6 months | Baseline, 6 months, 12 months | 
| Self-esteem | Rosenberg self-esteem scale | Baseline, 3 months, 6 months, 12 months | 
| Therapeutic alliance | Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ) | Baseline, 3 months, 6 months, 12 months | 
| Anxiety symptoms (PHQ-D) | Anxiety as rated by the PHQ-D anxiety scale | Baseline, 3 months, 6 months, 12 months | 
| Panic symptoms (PHQ-D) | Panic symptoms as measured by the PHQ-D | Baseline, 3 months, 6 months, 12 months | 
| Somatisation (PHQ-D) | Somatisation as measured by the PHQ-D | Baseline, 3 months, 6 months, 12 months | 
| General anxiety disorder (GAD-7) | Symptoms of general anxiety disorder measured by the GAD-7 | Baseline, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, stepped care, evidence-based medicine, health services research, psychotherapy, complex intervention, guideline