Clinical effectiveness of patient-targeted feedback following depression screening in general practice (GET.FEEDBACK.GP): an investigator-initiated, prospective, multicentre, three-arm, observer-blinded, randomised controlled trial in Germany.

BACKGROUND: Screening for depression in primary care alone is not sufficient to improve clinical outcomes. However, targeted feedback of the screening results to patients might result in beneficial effects. The GET.FEEDBACK.GP trial investigated whether targeted feedback of the depression screening result to patients, in addition to feedback to general practitioners (GPs), leads to greater reductions in depression severity than GP feedback alone or no feedback. METHODS: The GET.FEEDBACK.GP trial was an investigator-initiated, multicentre, three-arm, observer-blinded, randomised controlled trial. Depression screening was conducted electronically using the Patient Health Questionnaire-9 (PHQ-9) in 64 GP practices across five regions in Germany while patients were waiting to see their GP. Currently undiagnosed patients (aged ≥18 years) who screened positive for depression (PHQ-9 score ≥10), were proficient in the German language, and had a personal consultation with a GP were randomly assigned (1:1:1) into a group that received no feedback on their depression screening result, a group in which only the GP received feedback, or a group in which both GP and patient received feedback. Randomisation was stratified by treating GP and PHQ-9 depression severity. Trial staff were masked to patient enrolment and study group allocation and GPs were masked to the feedback recieved by the patient. Written feedback, including the screening result and information on depression, was provided to the relevant groups before the consultation. The primary outcome was PHQ-9-measured depression severity at 6 months after randomisation. An intention-to-treat analysis was conducted for patients who had at least one follow-up visit. This study is registered at ClinicalTrials.gov (NCT03988985) and is complete. FINDINGS: Between July 17, 2019, and Jan 31, 2022, 25 279 patients were approached for eligibility screening, 17 150 were excluded, and 8129 patients completed screening, of whom 1030 (12·7%) screened positive for depression. 344 patients were randomly assigned to receive no feedback, 344 were assigned to receive GP-targeted feedback, and 339 were assigned to receive GP-targeted plus patient-targeted feedback. 252 (73%) patients in the no feedback group, 252 (73%) in the GP-targeted feedback group, and 256 (76%) in the GP-targeted and patient-targeted feedback group were included in the analysis of the primary outcome at 6 months, which reflected a follow-up rate of 74%. Gender was reported as female by 637 (62·1%) of 1025 participants, male by 384 (37·5%), and diverse by four (0·4%). 169 (16%) of 1026 patients with available migration data had a migration background. Mean age was 39·5 years (SD 15·2). PHQ-9 scores improved for each group between baseline and 6 months by -4·15 (95% CI -4·99 to -3·30) in the no feedback group, -4·19 (-5·04 to -3·33) in the GP feedback group, and -4·91 (-5·76 to -4·07) in the GP plus patient feedback group, with no significant difference between the three groups (global p=0·13). The difference in PHQ-9 scores when comparing the GP plus patient feedback group with the no feedback group was -0·77 (-1·60 to 0·07, d=-0·16) and when comparing with the GP-only feedback group was -0·73 (-1·56 to 0·11, d=-0·15). No increase in suicidality was observed as an adverse event in either group. INTERPRETATION: Providing targeted feedback to patients and GPs after depression screening does not significantly reduce depression severity compared with GP feedback alone or no feedback. Further research is required to investigate the potential specific effectiveness of depression screening with systematic feedback for selected subgroups. FUNDING: German Innovation Fund. TRANSLATION: For the German translation of the abstract see Supplementary Materials section.

Nurses' experiences of a screening and associated psychosomatic consultation service for mental comorbidities in somatic care inpatients - a qualitative study.

Background: Screening for mental comorbidities and related liaison service can reduce hospital length of stay in somatic hospital care. To develop, test and sustain such health care services, stakeholder feedback is required. One of the most important stakeholders in general hospital care and health care processes are nurses. Aim: The aim of this study is to explore nurses' experiencess on standardized nurse-led screening for mental comorbidities and associated psychosomatic consultation service in routine somatic inpatient care. Method: Semi-structured qualitative interviews were conducted with 18 nurses that were involved in a nurse-led screening service for mental comorbidities on internal medicine or dermatological wards. Data were analyzed using thematic analysis. Results: Eight thematic groups were developed. On the one hand, participants reported benefits of screening: mental health education, general mental health awareness, holistic treatment approach, opportunity to build rapport with patients and reduction in workload. On the other hand, possible psychological effects of the intervention, reasons why patients may not want to be referred and application requirements to facilitate delivery were identified. None of the nurses opposed screening and associated psychosomatic consultation service. Conclusion: All nurses endorsed the screening intervention and considered it meaningful. Nurses particularly emphasized the potential for holistic patient care and nurses' improved skills and competencies, but partly critizised current application requirements. Relevance to clinical practice: This study adds on existent evidence on nurse-led screening for mental comorbidities and associated psychosomatic consultation service by emphasizing its potential to improve both patient care as well as nurses' perceived self-efficacy and job satisfaction. To take full advantage of this potential, however, usability improvements, regular supervision, and ongoing training for nurses need to be considered.

Clinical effectiveness of patient-oriented depression feedback in primary care: The empirical method of the GET.FEEDBACK.GP multicenter randomized controlled trial.

GET.FEEDBACK.GP1 is a multicenter randomized controlled trial testing the efficacy of patient-oriented depression feedback in primary care. This paper describes the complex methods and procedures of the trial. The primary outcome is depression severity six months after feedback, and we vary who is the target of the feedback as follows: no one receives feedback, only general practitioners receive feedback, and both patients and general practitioners receive feedback. The procedure includes a baseline assessment in primary care practices and three telephone follow-up interviews after one, six, and twelve months. The patients completed a baseline assessment, which determined their depression severity. Those with at least a moderate depression severity (PHQ-95 ≥ 10) were randomly allocated to three groups stratified by depression severity. A standardized mean difference of d = 0.25 with power 1 - ß = 0.80 required a total sample size of N = 699. The patients provided responses regarding the primary and secondary outcomes at follow-up. The extensive planning for GET.FEEDBACK.GP involved experts from diverse medical specialties and external corporations. Of particular importance were (a) blinding in the study inclusion and random assignment with data capture software, (b) representative and unbiased patient selection in practice waiting rooms, (c) a data management and safety plan supplied by a specialized trial center, and (d) the use of participant pseudonyms supplied by a specialized service (Mainzelliste). The data collection started in July 2019 and will continue until June 2022. Five university study centers in Germany are participating in the trial.

[Early Detection of Psychological Comorbidity in Patients Admitted to Dermatological and Internal Medicine Wards: A New Care Model for Psychosomatic Consultation Service]. / Früherkennung von psychischer Komorbidität in der stationären dermatologischen und internistischen Versorgung: Darstellung eines neuen Versorgungskonzeptes.

This article explains the development and implementation of a psychosomatic screening and consultation service for inpatient somatic care. Approximately one in six somatic inpatients has a mental disorder. It is estimated that only half of these cases are properly identified. Consequently, a large proportion of patients remains untreated. To address this gap in care, a psychosomatic early detection programme was developed by an interdisciplinary working group. This programme is based on the Patient Health Questionnaire-4 (PHQ-4), a psychometrically very well evaluated ultra-short screening questionnaire for the detection of depressive and anxiety disorders. For implementation in routine inpatient care, the PHQ-4 was programmed as a form in the electronic medical record and administered by nursing staff during the admission interview. If the PHQ-4 screening result indicates the presence of a mental comorbidity and the patient expresses a wish for assessment of this disorder, a psychosomatic consultation is automatically ordered. The PHQ-4 was implemented into the clinical routine in four internal medicine and three dermatology wards of the University Medical Center Hamburg-Eppendorf. Documentation of the early diagnosis in the electronic patient record is a minimally costly, less time-consuming and practicable method of providing patients with holistic care through rapid interdisciplinary referral. An evaluation of cost-effectiveness, clinical efficiency, and acceptance is still pending.

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

BACKGROUND: Patient and public involvement (PPI) is increasingly required in mental health services research. To empower patients to actively address depression, the GET.FEEDBACK.GP study evaluates a patient-targeted feedback intervention after depression screening using the Patient Health Questionnaire (PHQ-9). OBJECTIVE: To refine the patient-targeted feedback from a previous study within a participatory research team (PRT) by conducting workshops to investigate patients' needs and preferences for feedback. To evaluate the process and outcome of PPI. DESIGN: Patient and public involvement was carried out on the levels of collaboration and consultation. A PRT of patient partners and researchers planned and conducted three workshops with patients. Patients' needs were investigated using a focus group. Participants prioritized needs, discussed feedback drafts and evaluated two drafts using cognitive debriefings. Researchers of the PRT communicated the results at project level. PPI was evaluated using the Public and Patient Engagement Evaluation Tools (PPEET). SETTING AND PARTICIPANTS: A purposeful sampling of N = 12 patients with experiences of depression participated in at least one workshop. RESULTS: Relevant content-related needs about feedback (eg no distinction between severe and moderate symptoms), recommendations for action and patient-relevant information were considered. Needs for comprehensible, valuing, nonstigmatizing language and design elements (eg dimensional bar) were implemented. Workshops and PRT were positively evaluated. DISCUSSION AND CONCLUSIONS: Patient and public involvement influenced the content, wording and design of the feedback. Strengths include two levels of PPI, methodical diversity and purposeful sampling. Limitations include the lack of inclusion of patients who are unaware of their depression. The evaluated PPI concept can be useful for future studies.

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

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.

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 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.

Post-psychotic depression: Paranoia and the damage done.

To mitigate the often chronic course of schizophrenia and improve functional outcome, researchers are increasingly interested in prodromal states and psychological risk factors that may predict the outbreak of psychotic symptoms, but are also amenable to change. In recent years, depressive symptoms have been proposed as precursors of psychosis and some interventional studies indicate that the amelioration of depressive symptoms and depression-related thinking styles (e.g., worrying) improves positive symptoms, thereby "killing two birds with one stone". Yet, in a prior study, we were unable to find a strong specific predictive role of depression on paranoia over three years, which may have been due to the use of a nonclinical sample with minimal/mild symptom fluctuations. To address this further, in the present study we adopted a similar methodological approach but assessed a large patient sample with a schizophrenia spectrum disorder at three assessment points; baseline (N = 250), 6 weeks later (n = 207, 82.8% retention) and 6 months after baseline (n = 185, 74% retention). Using cross-lagged modeling, we assessed paranoia with the respective items from the Positive and Negative Syndrome Scale (PANSS) and the Psychosis Rating Scales (PSYRATS) delusions subscale. Depression was measured using the Patient Health Questionnaire-9 (PHQ-9) and the Calgary Depression Scale for Schizophrenia (CDSS). We could identify a significant pathway from depression to paranoia from baseline to post (negative association) but not from post to follow-up. Paranoia significantly predicted depressive symptoms for both intervals. Our findings do not refute claims that depression may precede or even predict psychosis, but such a linkage does not seem to be ubiquitous.