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. 2020 Sep 21;10(9):e035973.
doi: 10.1136/bmjopen-2019-035973.

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial

Sebastian Kohlmann  1 , Marco Lehmann  2 , Marion Eisele  3 , Lea-Elena Braunschneider  2 , Gabriella Marx  3 , Antonia Zapf  4 , Karl Wegscheider  4 , Martin Härter  5 , Hans-Helmut König  6 , Jürgen Gallinat  7 , Stefanie Joos  8 , Gaby Resmark  2 , Antonius Schneider  9 , Christine Allwang  10 , Joachim Szecsenyi  11 , Christoph Nikendei  12 , Sven Schulz  13 , Katja Brenk-Franz  14 , Martin Scherer  3 , Bernd Löwe  2
Affiliations

Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial

Sebastian Kohlmann et al. BMJ Open. .

Abstract

Introduction: Approximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients' needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care.

Methods and analysis: The multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle.

Ethics and dissemination: The Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language.

Trial registration number: NCT03988985.

Keywords: adult psychiatry; depression & mood disorders; primary care.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow chart of the multicentre GET.FEEDBACK.GP randomised controlled tria according to the Consolidated Standards of Reporting Trials statement. GP, general practitioner; PHQ-9, Patient HealthQuestionnaire-9.
Figure 2
Figure 2
Patient-targeted feedback (the image was purchased from iStock).
See this image and copyright information in PMC

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