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.
Major depression is one of the most significant clinical disorders. In primary care, every sixth patient suffers from increased depression level, which is associated with higher risk of suicide, increased risk of onset and progression of chronic physical conditions. Still, depression is under recognized and undertreated in primary care. Moreover, evidence regarding the efficacy of depression screening in primary care is insufficient to draw clear conclusions. Our previous mono-center depression screening trial in cardiac patients, provides first evidence that written patient-targeted feedback improves depression severity, encourages greater patient participation and engagement in mental health. To amplify these effects, the multi-center GET.FEEDBACK.GP randomized controlled trial is now 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
1,030
The feedback for the patient contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.
The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.
University Medical Center Heidelberg
Heidelberg, Baden-Würtenberg, Germany
University Medical Center Tuebingen
Tübingen, Baden-Würtenberg, Germany
Technical University of Munich - Medical Faculty
Munich, Bavaria, Germany
University Medical Center Jena
Jena, Thuringia, Germany
University Medical Center Hamburg
Hamburg, Germany
Depression severity (Questionnaire: Patient Health Questionnaire-9)
Level of depression severity six months after screening (Patient Health Questionnaire-9)
Time frame: Six months after screening
Depression severity (Questionnaire: Patient Health Questionnaire-9)
Level of depression severity one and twelve months after screening (Questionnaire: Patient Health Questionnaire-9)
Time frame: One and twelve months after screening
Depression treatment
Proportion of patients treated according to German Guideline based recommendations
Time frame: Six and twelve months after screening
Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)
Direct and indirect health costs (Client Sociodemographic and Service Receipt Inventory)
Time frame: Six and twelve months after screening
Quality-adjusted life years (Questionnaire: EuroQol-5D)
Quality-adjusted years of life and quality of life (EuroQol-5D)
Time frame: Six and twelve months after screening
Anxiety (Questionnaire: Generalized Anxiety Disorder-7)
Level of anxiety severity one, six and twelve months after screening
Time frame: One, six and twelve months after screening
Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)
Level of somatic symptom severity one, six and twelve months after screening
Time frame: One, six and twelve months after screening
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