Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial
Joachim Szecsenyi,
Karl Wegscheider,
Antonius Schneider,
Jürgen Gallinat,
Antonia Zapf,
Sebastian Kohlmann,
Marco Lehmann,
Marion Eisele,
Lea-Elena Braunschneider,
Gabriella Marx,
Stefanie Joos,
Gaby Resmark,
Christine Allwang,
Christoph Nikendei,
Sven Schulz,
Katja Brenk-Franz
Affiliations
Joachim Szecsenyi
Institute for Applied Quality Improvement & Research in Health Care (aQua), Göttingen, Germany
Karl Wegscheider
Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Antonius Schneider
TUM School of Medicine, Institute of General Practice and Health Services Research, Technical University of Munich, München, Germany
Jürgen Gallinat
Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Antonia Zapf
Department of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Sebastian Kohlmann
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Marco Lehmann
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Marion Eisele
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Lea-Elena Braunschneider
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Gabriella Marx
Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Stefanie Joos
Department of Primary Care, University Medical Centre Tübingen, Tübingen, Germany
Gaby Resmark
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Christine Allwang
Department of Psychosomatic Medicine and Psychotherapy, Technical University of Munich Hospital Rechts der Isar, Munchen, Germany
Christoph Nikendei
Department of Psychosomatic Medicine and Psychotherapy for General Internal Medicine and Psychosomatics, University Medical Centre of Heidelberg, Heidelberg, Germany
Sven Schulz
Department of Primary Care, University Medical Centre Jena, Jena, Germany
Katja Brenk-Franz
Department of Psychosocial Medicine and Psychotherapy, University Medical Centre Jena, Jena, Germany
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.
