Depression Clinical Trial
Official title:
Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices: The GET.FEEDBACK.GP Multicentre Randomized Controlled Trial
Verified date | July 2023 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The multi-center GET.FEEDBACK.GP randomized controlled trial is designed based on patients' needs and preferences. In order to evaluate the effect of feedback in the broader setting of primary care, a total of 1076 primary care patients with elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups who either receive a) patient-targeted and physician-targeted feedback of depression screening results, b) a physician-targeted feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' behavior and cognitions after the screening, depression care according to German guideline recommendations and the health economic evaluation.
Status | Completed |
Enrollment | 1030 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Gender: male, female, diverse - Maximum Age: no maximum age - Attendance in primary care with medical consultation - Age = 18 years; - Sufficient language skills; - Informed consent - Patient Health Questionnaire-9 > 9 points Exclusion Criteria: - Life threatening health status; - Severe somatic or/and psychological disorder that needs urgent treatment; - Known diagnosis of a depressive disorder - Current depression treatment - Acute suicidal tendency; - Severe cognitive or/and visual difficulties; - Not being able to fill out questionnaires - No contact details |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg | Hamburg | |
Germany | University Medical Center Heidelberg | Heidelberg | Baden-Würtenberg |
Germany | University Medical Center Jena | Jena | Thueringen |
Germany | Technical University of Munich - Medical Faculty | Munich | Bavaria |
Germany | University Medical Center Tuebingen | Tuebingen | Baden-Würtenberg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Federal Joint Committee |
Germany,
Kohlmann S, Lehmann M, Eisele M, Braunschneider LE, Marx G, Zapf A, Wegscheider K, Harter M, Konig HH, Gallinat J, Joos S, Resmark G, Schneider A, Allwang C, Szecsenyi J, Nikendei C, Schulz S, Brenk-Franz K, Scherer M, Lowe B. Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial. BMJ Open. 2020 Sep 21;10(9):e035973. doi: 10.1136/bmjopen-2019-035973. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression severity (Questionnaire: Patient Health Questionnaire-9) | Level of depression severity six months after screening (Patient Health Questionnaire-9) | Six months after screening | |
Secondary | Depression severity (Questionnaire: Patient Health Questionnaire-9) | Level of depression severity one and twelve months after screening (Questionnaire: Patient Health Questionnaire-9) | One and twelve months after screening | |
Secondary | Depression treatment | Proportion of patients treated according to German Guideline based recommendations | Six and twelve months after screening | |
Secondary | Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory) | Direct and indirect health costs (Client Sociodemographic and Service Receipt Inventory) | Six and twelve months after screening | |
Secondary | Quality-adjusted life years (Questionnaire: EuroQol-5D) | Quality-adjusted years of life and quality of life (EuroQol-5D) | Six and twelve months after screening | |
Secondary | Anxiety (Questionnaire: Generalized Anxiety Disorder-7) | Level of anxiety severity one, six and twelve months after screening | One, six and twelve months after screening | |
Secondary | Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8) | Level of somatic symptom severity one, six and twelve months after screening | One, six and twelve months after screening |
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