Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial
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 patient...
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BMJ Publishing Group
2020-09-01
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| Online Access: | https://bmjopen.bmj.com/content/10/9/e035973.full |
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| author | Joachim Szecsenyi Hans-Helmut König Karl Wegscheider Martin Härter Bernd Löwe Antonius Schneider Martin Scherer 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 |
| author_facet | Joachim Szecsenyi Hans-Helmut König Karl Wegscheider Martin Härter Bernd Löwe Antonius Schneider Martin Scherer 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 |
| author_sort | Joachim Szecsenyi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-07fde27f49654f5ea483576c860b5fcd |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-07fde27f49654f5ea483576c860b5fcd2025-01-08T15:45:14ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2019-035973Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trialJoachim Szecsenyi0Hans-Helmut König1Karl Wegscheider2Martin Härter3Bernd Löwe4Antonius Schneider5Martin Scherer6Jürgen Gallinat7Antonia Zapf8Sebastian Kohlmann9Marco Lehmann10Marion Eisele11Lea-Elena Braunschneider12Gabriella Marx13Stefanie Joos14Gaby Resmark15Christine Allwang16Christoph Nikendei17Sven Schulz18Katja Brenk-Franz19Department of General Practice and Health Services Research, Heidelberg University, Im Neuenheimer Feld 130.3, Heidelberg, GermanyDepartment for Health Economics and Health Services Research, Universitatsklinikum Hamburg-Eppendorf, Hamburg, GermanyDepartment of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany1 Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyInstitute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Primary Care, Technical University of Munich Hospital Rechts der Isar, Munchen, Germanyprofessor of health services researchDepartment of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Biostatistics and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Primary Medical Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany4 Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyInstitute for General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, Technical University of Munich Hospital Rechts der Isar, Munchen, GermanyDepartment of General Internal Medicine and Psychosomatics, University Hospital Heidelberg, Heidelberg, GermanyInstitute of General Practice and Family Medicine, Jena University Hospital, Jena, GermanyDepartment of Psychosocial Medicine and Psychotherapy, University Medical Centre Jena, Jena, GermanyIntroduction 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.https://bmjopen.bmj.com/content/10/9/e035973.full |
| spellingShingle | Joachim Szecsenyi Hans-Helmut König Karl Wegscheider Martin Härter Bernd Löwe Antonius Schneider Martin Scherer 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 Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial BMJ Open |
| title | Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial |
| title_full | Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial |
| title_fullStr | Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial |
| title_full_unstemmed | Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial |
| title_short | Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial |
| title_sort | depression screening using patient targeted feedback in general practices study protocol of the german multicentre get feedback gp randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/9/e035973.full |
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