Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial
IntroductionApproximately 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...
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| creator | Kohlmann, Sebastian Lehmann, Marco Eisele, Marion Braunschneider, Lea-Elena Marx, Gabriella Zapf, Antonia Wegscheider, Karl Härter, Martin König, Hans-Helmut Gallinat, Jürgen Joos, Stefanie Resmark, Gaby Schneider, Antonius Allwang, Christine Szecsenyi, Joachim Nikendei, Christoph Schulz, Sven Brenk-Franz, Katja Scherer, Martin Löwe, Bernd |
| description | IntroductionApproximately 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 analysisThe 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 disseminationThe 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 numberNCT03988985. |
| doi_str_mv | 10.1136/bmjopen-2019-035973 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_pubmed_primary_32958483</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_07fde27f49654f5ea483576c860b5fcd</doaj_id><sourcerecordid>2444878175</sourcerecordid><originalsourceid>FETCH-LOGICAL-b538t-ada6ffcf406886916463f6b8c71928e5ae20161a35f02db2ebc506713955b42a3</originalsourceid><addsrcrecordid>eNqNks1u1DAUhSMEolXpEyAhS2zYZHDi37BAKtPpUFEJFmVtOc71NENiB9tB6tPwqnh-qFpWeBFf3Xz3JPfoFMXrCi-qivD37bj1E7iyxlVTYsIaQZ4VpzWmtOSYseeP6pPiPMYtzoeyhrH6ZXFC6oZJKslp8fsSpgAx9t6haAKA690GzXH3nHTqwaUy6bCBBB2yAF2rzQ_UO7QBB0EPaArapN5A_IBimrv73PDJGz8gb1G6A7SGMGqHxnnYYS6F3FrdLq5Wq8tPF8svi_U3FLTr_NjH_AnjM-GHIZcp9Hp4VbyweohwfrzPiu9Xq9vl5_Lm6_p6eXFTtozIVOpOc2uNpZhLyZuKU04sb6URVVNLYBqyUbzShFlcd20NrWGYi4pkQ1paa3JWXB90O6-3agr9qMO98rpX-4YPG6VDXmAAhYXtoBaWNpxRy0BnI5ngRnLcMmu6rPXxoDXN7Qjdfmk9PBF9-sb1d2rjfynBsJCMZ4F3R4Hgf84Qk8rmGBgG7cDPUdWUUilkJVhG3_6Dbv0cXLZqT7Gai6bJFDlQJvgYA9iHn6mw2uVJHfOkdnlShzzlqTeP93iY-ZueDCwOQJ7-L8U_kmvZLw</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2444526799</pqid></control><display><type>article</type><title>Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial</title><source>BMJ Open Access Journals</source><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central Open Access</source><source>PubMed Central</source><creator>Kohlmann, Sebastian ; Lehmann, Marco ; Eisele, Marion ; Braunschneider, Lea-Elena ; Marx, Gabriella ; Zapf, Antonia ; Wegscheider, Karl ; Härter, Martin ; König, Hans-Helmut ; Gallinat, Jürgen ; Joos, Stefanie ; Resmark, Gaby ; Schneider, Antonius ; Allwang, Christine ; Szecsenyi, Joachim ; Nikendei, Christoph ; Schulz, Sven ; Brenk-Franz, Katja ; Scherer, Martin ; Löwe, Bernd</creator><creatorcontrib>Kohlmann, Sebastian ; Lehmann, Marco ; Eisele, Marion ; Braunschneider, Lea-Elena ; Marx, Gabriella ; Zapf, Antonia ; Wegscheider, Karl ; Härter, Martin ; König, Hans-Helmut ; Gallinat, Jürgen ; Joos, Stefanie ; Resmark, Gaby ; Schneider, Antonius ; Allwang, Christine ; Szecsenyi, Joachim ; Nikendei, Christoph ; Schulz, Sven ; Brenk-Franz, Katja ; Scherer, Martin ; Löwe, Bernd</creatorcontrib><description>IntroductionApproximately 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 analysisThe 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 disseminationThe 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 numberNCT03988985.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2019-035973</identifier><identifier>PMID: 32958483</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Clinical outcomes ; Consent ; Depression - diagnosis ; Feasibility studies ; Feedback ; General Practitioners ; Germany ; Humans ; Hypotheses ; Intervention ; Language ; Medical screening ; Mental depression ; Mental Health ; Multicenter Studies as Topic ; Nurses ; Participation ; Patients ; Primary care ; Randomized Controlled Trials as Topic</subject><ispartof>BMJ open, 2020-09, Vol.10 (9), p.e035973-e035973</ispartof><rights>Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2020 Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b538t-ada6ffcf406886916463f6b8c71928e5ae20161a35f02db2ebc506713955b42a3</citedby><cites>FETCH-LOGICAL-b538t-ada6ffcf406886916463f6b8c71928e5ae20161a35f02db2ebc506713955b42a3</cites><orcidid>0000-0003-2974-3142 ; 0000-0003-1307-4618 ; 0000-0002-8817-3365</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/10/9/e035973.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/10/9/e035973.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,27549,27550,27924,27925,53791,53793,77601,77632</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32958483$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kohlmann, Sebastian</creatorcontrib><creatorcontrib>Lehmann, Marco</creatorcontrib><creatorcontrib>Eisele, Marion</creatorcontrib><creatorcontrib>Braunschneider, Lea-Elena</creatorcontrib><creatorcontrib>Marx, Gabriella</creatorcontrib><creatorcontrib>Zapf, Antonia</creatorcontrib><creatorcontrib>Wegscheider, Karl</creatorcontrib><creatorcontrib>Härter, Martin</creatorcontrib><creatorcontrib>König, Hans-Helmut</creatorcontrib><creatorcontrib>Gallinat, Jürgen</creatorcontrib><creatorcontrib>Joos, Stefanie</creatorcontrib><creatorcontrib>Resmark, Gaby</creatorcontrib><creatorcontrib>Schneider, Antonius</creatorcontrib><creatorcontrib>Allwang, Christine</creatorcontrib><creatorcontrib>Szecsenyi, Joachim</creatorcontrib><creatorcontrib>Nikendei, Christoph</creatorcontrib><creatorcontrib>Schulz, Sven</creatorcontrib><creatorcontrib>Brenk-Franz, Katja</creatorcontrib><creatorcontrib>Scherer, Martin</creatorcontrib><creatorcontrib>Löwe, Bernd</creatorcontrib><title>Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionApproximately 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 analysisThe 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 disseminationThe 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 numberNCT03988985.</description><subject>Clinical outcomes</subject><subject>Consent</subject><subject>Depression - diagnosis</subject><subject>Feasibility studies</subject><subject>Feedback</subject><subject>General Practitioners</subject><subject>Germany</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Intervention</subject><subject>Language</subject><subject>Medical screening</subject><subject>Mental depression</subject><subject>Mental Health</subject><subject>Multicenter Studies as Topic</subject><subject>Nurses</subject><subject>Participation</subject><subject>Patients</subject><subject>Primary care</subject><subject>Randomized Controlled Trials as Topic</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNks1u1DAUhSMEolXpEyAhS2zYZHDi37BAKtPpUFEJFmVtOc71NENiB9tB6tPwqnh-qFpWeBFf3Xz3JPfoFMXrCi-qivD37bj1E7iyxlVTYsIaQZ4VpzWmtOSYseeP6pPiPMYtzoeyhrH6ZXFC6oZJKslp8fsSpgAx9t6haAKA690GzXH3nHTqwaUy6bCBBB2yAF2rzQ_UO7QBB0EPaArapN5A_IBimrv73PDJGz8gb1G6A7SGMGqHxnnYYS6F3FrdLq5Wq8tPF8svi_U3FLTr_NjH_AnjM-GHIZcp9Hp4VbyweohwfrzPiu9Xq9vl5_Lm6_p6eXFTtozIVOpOc2uNpZhLyZuKU04sb6URVVNLYBqyUbzShFlcd20NrWGYi4pkQ1paa3JWXB90O6-3agr9qMO98rpX-4YPG6VDXmAAhYXtoBaWNpxRy0BnI5ngRnLcMmu6rPXxoDXN7Qjdfmk9PBF9-sb1d2rjfynBsJCMZ4F3R4Hgf84Qk8rmGBgG7cDPUdWUUilkJVhG3_6Dbv0cXLZqT7Gai6bJFDlQJvgYA9iHn6mw2uVJHfOkdnlShzzlqTeP93iY-ZueDCwOQJ7-L8U_kmvZLw</recordid><startdate>20200921</startdate><enddate>20200921</enddate><creator>Kohlmann, Sebastian</creator><creator>Lehmann, Marco</creator><creator>Eisele, Marion</creator><creator>Braunschneider, Lea-Elena</creator><creator>Marx, Gabriella</creator><creator>Zapf, Antonia</creator><creator>Wegscheider, Karl</creator><creator>Härter, Martin</creator><creator>König, Hans-Helmut</creator><creator>Gallinat, Jürgen</creator><creator>Joos, Stefanie</creator><creator>Resmark, Gaby</creator><creator>Schneider, Antonius</creator><creator>Allwang, Christine</creator><creator>Szecsenyi, Joachim</creator><creator>Nikendei, Christoph</creator><creator>Schulz, Sven</creator><creator>Brenk-Franz, Katja</creator><creator>Scherer, Martin</creator><creator>Löwe, Bernd</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0003-2974-3142</orcidid><orcidid>https://orcid.org/0000-0003-1307-4618</orcidid><orcidid>https://orcid.org/0000-0002-8817-3365</orcidid></search><sort><creationdate>20200921</creationdate><title>Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial</title><author>Kohlmann, Sebastian ; Lehmann, Marco ; Eisele, Marion ; Braunschneider, Lea-Elena ; Marx, Gabriella ; Zapf, Antonia ; Wegscheider, Karl ; Härter, Martin ; König, Hans-Helmut ; Gallinat, Jürgen ; Joos, Stefanie ; Resmark, Gaby ; Schneider, Antonius ; Allwang, Christine ; Szecsenyi, Joachim ; Nikendei, Christoph ; Schulz, Sven ; Brenk-Franz, Katja ; Scherer, Martin ; Löwe, Bernd</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b538t-ada6ffcf406886916463f6b8c71928e5ae20161a35f02db2ebc506713955b42a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Clinical outcomes</topic><topic>Consent</topic><topic>Depression - diagnosis</topic><topic>Feasibility studies</topic><topic>Feedback</topic><topic>General Practitioners</topic><topic>Germany</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Intervention</topic><topic>Language</topic><topic>Medical screening</topic><topic>Mental depression</topic><topic>Mental Health</topic><topic>Multicenter Studies as Topic</topic><topic>Nurses</topic><topic>Participation</topic><topic>Patients</topic><topic>Primary care</topic><topic>Randomized Controlled Trials as Topic</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kohlmann, Sebastian</creatorcontrib><creatorcontrib>Lehmann, Marco</creatorcontrib><creatorcontrib>Eisele, Marion</creatorcontrib><creatorcontrib>Braunschneider, Lea-Elena</creatorcontrib><creatorcontrib>Marx, Gabriella</creatorcontrib><creatorcontrib>Zapf, Antonia</creatorcontrib><creatorcontrib>Wegscheider, Karl</creatorcontrib><creatorcontrib>Härter, Martin</creatorcontrib><creatorcontrib>König, Hans-Helmut</creatorcontrib><creatorcontrib>Gallinat, Jürgen</creatorcontrib><creatorcontrib>Joos, Stefanie</creatorcontrib><creatorcontrib>Resmark, Gaby</creatorcontrib><creatorcontrib>Schneider, Antonius</creatorcontrib><creatorcontrib>Allwang, Christine</creatorcontrib><creatorcontrib>Szecsenyi, Joachim</creatorcontrib><creatorcontrib>Nikendei, Christoph</creatorcontrib><creatorcontrib>Schulz, Sven</creatorcontrib><creatorcontrib>Brenk-Franz, Katja</creatorcontrib><creatorcontrib>Scherer, Martin</creatorcontrib><creatorcontrib>Löwe, Bernd</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kohlmann, Sebastian</au><au>Lehmann, Marco</au><au>Eisele, Marion</au><au>Braunschneider, Lea-Elena</au><au>Marx, Gabriella</au><au>Zapf, Antonia</au><au>Wegscheider, Karl</au><au>Härter, Martin</au><au>König, Hans-Helmut</au><au>Gallinat, Jürgen</au><au>Joos, Stefanie</au><au>Resmark, Gaby</au><au>Schneider, Antonius</au><au>Allwang, Christine</au><au>Szecsenyi, Joachim</au><au>Nikendei, Christoph</au><au>Schulz, Sven</au><au>Brenk-Franz, Katja</au><au>Scherer, Martin</au><au>Löwe, Bernd</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2020-09-21</date><risdate>2020</risdate><volume>10</volume><issue>9</issue><spage>e035973</spage><epage>e035973</epage><pages>e035973-e035973</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionApproximately 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 analysisThe 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 disseminationThe 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 numberNCT03988985.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>32958483</pmid><doi>10.1136/bmjopen-2019-035973</doi><orcidid>https://orcid.org/0000-0003-2974-3142</orcidid><orcidid>https://orcid.org/0000-0003-1307-4618</orcidid><orcidid>https://orcid.org/0000-0002-8817-3365</orcidid><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central Open Access; PubMed Central |
| subjects | Clinical outcomes Consent Depression - diagnosis Feasibility studies Feedback General Practitioners Germany Humans Hypotheses Intervention Language Medical screening Mental depression Mental Health Multicenter Studies as Topic Nurses Participation Patients Primary care Randomized Controlled Trials as Topic |
| title | Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial |
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