MedTrace Logo

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

NCT03988985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2023-07-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Federal Joint Committee

    collaborator OTHER_GOV

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Bernd Löwe, MD · Director of the Department of Psychosomatic Medicine and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988985 on ClinicalTrials.gov