Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices

Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices: The GET.FEEDBACK.GP Multicentre Randomized Controlled Trial

The multi-center GET.FEEDBACK.GP randomized controlled trial is designed based on patients' needs and preferences. In order to evaluate the effect of feedback in the broader setting of primary care, a total of 1076 primary care patients with elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups who either receive a) patient-targeted and physician-targeted feedback of depression screening results, b) a physician-targeted feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' behavior and cognitions after the screening, depression care according to German guideline recommendations and the health economic evaluation.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Patient-targeted feedback; Other: GP-targeted feedback

Detailed Description

Major depression is one of the most significant clinical disorders. In primary care, every sixth patient suffers from increased depression level, which is associated with higher risk of suicide, increased risk of onset and progression of chronic physical conditions. Still, depression is under recognized and undertreated in primary care. Moreover, evidence regarding the efficacy of depression screening in primary care is insufficient to draw clear conclusions. Our previous mono-center depression screening trial in cardiac patients, provides first evidence that written patient-targeted feedback improves depression severity, encourages greater patient participation and engagement in mental health. To amplify these effects, the multi-center GET.FEEDBACK.GP randomized controlled trial is now designed based on patients' needs and preferences. In order to evaluate the effect of feedback in the broader setting of primary care, a total of 1076 primary care patients with elevated levels of depression (PHQ-9 score ≥ 10) will be randomized into three groups who either receive a) patient-targeted and physician-targeted feedback of depression screening results, b) a physician-targeted feedback of depression screening results only, or c) no feedback of screening results. The primary study outcome is depression severity after 6 months, secondary outcomes include the patients' behavior and cognitions after the screening, depression care according to German guideline recommendations and the health economic evaluation.

• Study Type: Interventional
• Enrollment (Actual): 1030
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg
  • Baden-Würtenberg
    • Heidelberg, Baden-Würtenberg, Germany, 69120
      • University Medical Center Heidelberg
    • Tuebingen, Baden-Würtenberg, Germany, 72076
      • University Medical Center Tuebingen
  • Bavaria
    • Munich, Bavaria, Germany, 80333
      • Technical University of Munich - Medical Faculty
  • Thueringen
    • Jena, Thueringen, Germany, 07743
      • University Medical Center Jena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gender: male, female, diverse
• Maximum Age: no maximum age
• Attendance in primary care with medical consultation
• Age ≥ 18 years;
• Sufficient language skills;
• Informed consent
• Patient Health Questionnaire-9 > 9 points

Exclusion Criteria:

• Life threatening health status;
• Severe somatic or/and psychological disorder that needs urgent treatment;
• Known diagnosis of a depressive disorder
• Current depression treatment
• Acute suicidal tendency;
• Severe cognitive or/and visual difficulties;
• Not being able to fill out questionnaires
• No contact details

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PATIENT-GP-FEEDBACK; Using a randomized-controlled study design one third of the patients and their attending general practitioner will receive feedback after depression screening. The feedback for the patient contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment. The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.	Other: Patient-targeted feedback; The feedback for the patient contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.; Other: GP-targeted feedback; The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.
Active Comparator: GP-FEEDBACK; Using a randomized-controlled study design in one third of the cases only the attending general practitioner will receive feedback after depression screening. The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.	Other: GP-targeted feedback; The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.
No Intervention: NO-FEEDBACK; Using a randomized-controlled study design one third of the patients and their attending general practitioner will not receive any feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression severity (Questionnaire: Patient Health Questionnaire-9)	Level of depression severity six months after screening (Patient Health Questionnaire-9)	Six months after screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression severity (Questionnaire: Patient Health Questionnaire-9)	Level of depression severity one and twelve months after screening (Questionnaire: Patient Health Questionnaire-9)	One and twelve months after screening
Depression treatment	Proportion of patients treated according to German Guideline based recommendations	Six and twelve months after screening
Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)	Direct and indirect health costs (Client Sociodemographic and Service Receipt Inventory)	Six and twelve months after screening
Quality-adjusted life years (Questionnaire: EuroQol-5D)	Quality-adjusted years of life and quality of life (EuroQol-5D)	Six and twelve months after screening
Anxiety (Questionnaire: Generalized Anxiety Disorder-7)	Level of anxiety severity one, six and twelve months after screening	One, six and twelve months after screening
Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)	Level of somatic symptom severity one, six and twelve months after screening	One, six and twelve months after screening

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Federal Joint Committee
• Investigators: Principal Investigator: Bernd Löwe, MD, Director of the Department of Psychosomatic Medicine and Psychotherapy

Publications and helpful links

General Publications

• Kohlmann S, Lehmann M, Eisele M, Braunschneider LE, Marx G, Zapf A, Wegscheider K, Harter M, Konig HH, Gallinat J, Joos S, Resmark G, Schneider A, Allwang C, Szecsenyi J, Nikendei C, Schulz S, Brenk-Franz K, Scherer M, Lowe B. Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial. BMJ Open. 2020 Sep 21;10(9):e035973. doi: 10.1136/bmjopen-2019-035973.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 15, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Primary Care; Screening; General Practice; Feedback
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: UHHamburgEppendorfGetFeedback

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with the ethics approval of the Ethics Committee of the Hamburg Medical Association on April 8, 2019, (approval number PV6031) and the German Research Foundation guidelines for the handling of research data, deidentified data will be made available on request.
• IPD Sharing Time Frame: Data will become available six months after publication of the main findings. Data will be available for ten years after publication of the main findings.
• IPD Sharing Access Criteria: Data can be requested by the principal investigators. Data use and request underly the publication policy of the multicentre GET.FEEBDACK.GP RCT.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No