An interventional study of Active monitoring and Bibliotherapy in Depression, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-13.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 737 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: Bibliotherapy · Behavioral: Online self-help · Behavioral: Outpatient psychotherapy · Procedure: Psychiatric treatment · Behavioral: Combined psychotherapy and psychopharmacological treatment
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
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.
Patient works with online self-help program "Deprexis" under general physician's supervision.
Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
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.
Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
treatment as usual
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)
Time frame: Baseline, 3 months, 6 months, 12 months
Cost-benefit ratio (QALYs)
Cost-benefit ratio in quality-adjusted life years(QALYs)
Time frame: 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)
Time frame: Baseline, 3 months, 6 months, 12 months
Quality of life (EQ-5D)
Quality of life as measured by EuroQol's EQ-5D
Time frame: 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)
Time frame: 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
Time frame: Baseline, 6 months, 12 months
Self-esteem
Rosenberg self-esteem scale
Time frame: Baseline, 3 months, 6 months, 12 months
Therapeutic alliance
Patient-rated therapeutic alliance as measured by the Helping Alliace Questionnaire (HAQ)
Time frame: Baseline, 3 months, 6 months, 12 months
Anxiety symptoms (PHQ-D)
Anxiety as rated by the PHQ-D anxiety scale
Time frame: Baseline, 3 months, 6 months, 12 months
Panic symptoms (PHQ-D)
Panic symptoms as measured by the PHQ-D
Time frame: Baseline, 3 months, 6 months, 12 months
Somatisation (PHQ-D)
Somatisation as measured by the PHQ-D
Time frame: Baseline, 3 months, 6 months, 12 months
General anxiety disorder (GAD-7)
Symptoms of general anxiety disorder measured by the GAD-7
Time frame: Baseline, 3 months, 6 months, 12 months
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf