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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988985
• Other study ID #: UHHamburgEppendorfGetFeedback
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1030
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg	Hamburg
Germany	University Medical Center Heidelberg	Heidelberg	Baden-Würtenberg
Germany	University Medical Center Jena	Jena	Thueringen
Germany	Technical University of Munich - Medical Faculty	Munich	Bavaria
Germany	University Medical Center Tuebingen	Tuebingen	Baden-Würtenberg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Federal Joint Committee

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity (Questionnaire: Patient Health Questionnaire-9)	Level of depression severity six months after screening (Patient Health Questionnaire-9)	Six months after screening
Secondary	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
Secondary	Depression treatment	Proportion of patients treated according to German Guideline based recommendations	Six and twelve months after screening
Secondary	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
Secondary	Quality-adjusted life years (Questionnaire: EuroQol-5D)	Quality-adjusted years of life and quality of life (EuroQol-5D)	Six and twelve months after screening
Secondary	Anxiety (Questionnaire: Generalized Anxiety Disorder-7)	Level of anxiety severity one, six and twelve months after screening	One, six and twelve months after screening
Secondary	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