Patient involvement in developing a patient‐targeted feedback intervention after depression screening in primary care within the randomized controlled trial GET.FEEDBACK.GP

Seeralan, Tharanya; Härter, Martin; Koschnitzke, Cornelia; Schöll, Michael; Kohlmann, Sebastian; Lehmann, Marco; Eisele, Marion; Braunschneider, Lea-Elena; Marx, Gabriella; Scherer, Martin; Löwe, Bernd; Magaard, Julia Luise; Brütt, Anna Levke

doi:10.1111/hex.13039

Cited by 20 publications

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“…Several strengths of the DISCOVER trial should be highlighted as well. First, the feedback intervention is a result of an elaborated multistage development process, which combined strengths and perspectives of different domains: clinical, research, and IT/graphic design expertise, empirical evidence, and first-hand patients' needs and preferences ( Seeralan et al, 2020 ). Second, the selection of a broad range of further outcomes (depression care and help-seeking behaviour, additional clinical outcomes, intervention acceptance, illness beliefs, adverse events, and the health-economic evaluation) allows for a comprehensive trial evaluation.…”

Section: Discussionmentioning

confidence: 99%

“…The feedback intervention was developed in a multistage process. First, the underlying feedback version used in the preceding DEPSCREEN-INFO trial was subjected to re-evaluation and updating in several focus groups, involving patient representatives with depressive disorder ( Seeralan et al, 2020 ). Based on the results of this qualitative study, needs and preferences of the target group could be assessed and implemented, resulting in the feedback version used in the currently running GET.FEEDBACK.GP trial ( Kohlmann et al, 2020 ; see Supplemental Fig.…”

Section: Methodsmentioning

confidence: 99%

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The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER

Sikorski

König

Wegscheider

et al. 2021

Internet Interventions

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Background Depression is one of the most disabling disorders worldwide, yet it often remains undetected. One promising approach to address both early detection and disease burden is depression screening followed by direct feedback to patients. Evidence suggests that individuals often seek information regarding mental health on the internet. Thus, internet-based screening with automated feedback has great potential to address individuals with undetected depression. Objectives To determine whether automated feedback after internet-based depression screening reduces depression severity as compared to no feedback. Methods The internet-based, observer-blinded DISCOVER RCT aims to recruit a total of 1074 individuals. Participants will be screened for depression using the Patient Health Questionnaire (PHQ-9). In case of a positive screening result (PHQ-9 ≥ 10), participants with undetected depression will be randomised into one of three balanced study arms to receive either (a) no feedback (control arm), (b) standard feedback, or (c) tailored feedback on their screening result. The tailored feedback version will be adapted to participants' characteristics, i.e. symptom profile, preferences, and demographic characteristics. The primary hypothesis is that feedback reduces depression severity six months after screening compared to no feedback. The secondary hypothesis is that tailored feedback is more efficacious compared to standard feedback. Further outcomes are depression care, help-seeking behaviour, health-related quality of life, anxiety, somatic symptom severity, intervention acceptance, illness beliefs, adverse events, and a health economic evaluation. Follow-ups will be conducted one month and six months after screening by self-report questionnaires and clinical interviews. According to a statistical analysis plan, the primary outcome will be analysed on an intention-to-treat basis applying multilevel modelling. Discussion The results of the DISCOVER RCT will inform about how automated feedback after internet-based screening could improve early detection and resolution of depression. Ways of dissemination and how the trial can contribute to an understanding of help-seeking behaviour processes will be discussed. If the results show that automated feedback after internet-based depression screening can reduce depression severity, the intervention could be easily implemented and might substantially reduce the disease burden of individuals with undetected depression. Ethical approval The study is approved by the Ethics Committee of the Hamburg Medical Association. Trial registration The trial was registered at ClinicalTrials.gov in November 2020 (identifier: NCT04633096 ).

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER

Sikorski

König

Wegscheider

et al. 2021

Internet Interventions

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“…Focus groups with patients with lived experiences of depression were conducted to refine the patient-targeted feedback from the DEPSCREEN-INFO trial. 17 Patients will not be involved in the design of the trial. A participatory research team including patients formally suffering from depression will be invited to comment on the development and the results of the trial.…”

Section: Methods and Analysismentioning

confidence: 99%

“…The details of this qualitative study are described elsewhere. 17 Measures Baseline data will be collected in the GP practice by a study nurse, whereby the endpoints for the 1-month, 6-month and 12-month follow-ups will be collected via telephone interviews. The assessors (MD; BSc or MSc Psychology) will be trained before conducting interviews.…”

Section: Gp and Patient Feedbackmentioning

confidence: 99%

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

et al. 2020

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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.

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“…Qualitative interviews were seen as appropriate to give every GP the possibility to explain their social reality and personal view. A semistructured interview guideline was developed (LEB, TS, JM, SK) based on an interview manual that was used in a qualitative focus group study investigating patients' preferences and needs regarding depression screening and patient-targeted feedback [17] (see Online Appendix A). This was done to ensure similar prerequisites for the preparation of the different feedbacks in the context of the GET.…”

Section: Interview Guideline and Materialsmentioning

confidence: 99%

GPs’ views on the use of depression screening and GP-targeted feedback: a qualitative study

et al. 2020

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Purpose The first aim of this qualitative study was to identify general practitioners’ (GPs’) views on depression screening combined with GP-targeted feedback in primary care. The second aim was to determine the needs and preferences of GPs with respect to GP-targeted feedback to enhance the efficacy of depression screening. Methods A semistructured qualitative interview was conducted with officially registered GPs in Hamburg (Germany). Interviews were audio recorded and transcribed verbatim. An inductive approach was used to code the transcripts. Results Nine GPs (27 to 70 years; 5 male) from Hamburg, Germany, participated. Regarding depression screening combined with GP-targeted feedback, five thematic groups were identified: application of screening; screening and patient–physician relationships; GPs’ attitudes towards screening; benefits and concerns related to screening; and GPs’ needs and preferences regarding feedback. While the negative aspects of screening can be described in rather general terms (e.g., screening determines the mental health competence, screening threatens the doctor–patient relationship, revealing questions harm the patients), its advantages were very specific (e.g., promoting the identification of undetected cases, relief of the daily workload, wider communication channel to reach more patients). Standardized GP-targeted feedback of the screening results was perceived as helpful and purposeful. GPs preferred feedback materials that eased their clinical workload (e.g., short text with visuals, pictures, or images). Conclusion Addressing GPs’ needs is essential when implementing depression screening tools in clinical practice. To overcome prejudices and enhance the efficacy of screening, further education for GPs on the purpose and application on depression screening may be needed. Standardized GP-targeted feedback in combination with depression screening could be the missing link to improve the detection of depression in primary care.

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Patient involvement in developing a patient‐targeted feedback intervention after depression screening in primary care within the randomized controlled trial GET.FEEDBACK.GP

Abstract: This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 20 publications

References 49 publications

The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER

The efficacy of automated feedback after internet-based depression screening: Study protocol of the German, three-armed, randomised controlled trial DISCOVER

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

GPs’ views on the use of depression screening and GP-targeted feedback: a qualitative study

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