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

NCT03988985 | Completed DMC

• 1 other identifier: UHHamburgEppendorfGetFeedback
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Screening; Primary Care; General Practice; Feedback

Outcome Measures

Primary Outcomes (1)

• Depression severity (Questionnaire: Patient Health Questionnaire-9)

  Level of depression severity six months after screening (Patient Health Questionnaire-9)

  Six months after screening

Secondary Outcomes (6)

• Depression severity (Questionnaire: Patient Health Questionnaire-9)

  One and twelve months after screening

• Depression treatment

  Six and twelve months after screening

• Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)

  Six and twelve months after screening

• Quality-adjusted life years (Questionnaire: EuroQol-5D)

  Six and twelve months after screening

• Anxiety (Questionnaire: Generalized Anxiety Disorder-7)

  One, six and twelve months after screening

Study Arms (3)

PATIENT-GP-FEEDBACK

EXPERIMENTAL

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; Other: GP-targeted feedback

GP-FEEDBACK

ACTIVE COMPARATOR

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

NO-FEEDBACK

NO INTERVENTION

Using a randomized-controlled study design one third of the patients and their attending general practitioner will not receive any feedback.

Interventions

Patient-targeted feedback OTHER

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.

PATIENT-GP-FEEDBACK

GP-targeted feedback OTHER

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.

GP-FEEDBACK; PATIENT-GP-FEEDBACK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Federal Joint Committee: collaborator

Study Sites (5)

University Medical Center Heidelberg

Heidelberg, Baden-Würtenberg, 69120, Germany

Location

University Medical Center Tuebingen

Tübingen, Baden-Würtenberg, 72076, Germany

Location

Technical University of Munich - Medical Faculty

Munich, Bavaria, 80333, Germany

Location

University Medical Center Jena

Jena, Thuringia, 07743, Germany

Location

University Medical Center Hamburg

Hamburg, 20246, Germany

Location

Related Publications (3)

• 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.

  PMID: 32958483 BACKGROUND

• Kreis LG, Konig HH, Kohlmann S, Lowe B, Scherer M, Brettschneider C. Cost-effectiveness of targeted feedback interventions after depression screening in primary care: health economic evaluation of the GET.FEEDBACK.GP trial. BJPsych Open. 2026 Feb 2;12(2):e52. doi: 10.1192/bjo.2025.10945.

  PMID: 41621811 DERIVED

• Lowe B, Scherer M, Braunschneider LE, Marx G, Eisele M, Mallon T, Schneider A, Linde K, Allwang C, Joos S, Zipfel S, Schulz S, Rost L, Brenk-Franz K, Szecsenyi J, Nikendei C, Harter M, Gallinat J, Konig HH, Fierenz A, Vettorazzi E, Zapf A, Lehmann M, Kohlmann S. 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. Lancet Psychiatry. 2024 Apr;11(4):262-273. doi: 10.1016/S2215-0366(24)00035-X. Epub 2024 Feb 29.

  PMID: 38432236 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Bernd Löwe, MD

  Director of the Department of Psychosomatic Medicine and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 18, 2019
• Study Start: July 17, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

DE (5)