Clinical trial NCT03988985: Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices
Official title: Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices: The GET.FEEDBACK.GP Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Screening
Primary Care
General Practice
Feedback
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Federal Joint Committee
First posted: 2019-06-18
Enrollment: 1030
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression severity (Questionnaire: Patient Health Questionnaire-9)
timeFrame: Six months after screening
Secondary outcomes:
measure: Depression severity (Questionnaire: Patient Health Questionnaire-9)
timeFrame: One and twelve months after screening
measure: Depression treatment
timeFrame: Six and twelve months after screening
measure: Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory)
timeFrame: Six and twelve months after screening
measure: Quality-adjusted life years (Questionnaire: EuroQol-5D)
timeFrame: Six and twelve months after screening
measure: Anxiety (Questionnaire: Generalized Anxiety Disorder-7)
timeFrame: One, six and twelve months after screening
measure: Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8)
timeFrame: One, six and twelve months after screening
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Medical Center Heidelberg
state: Baden-Würtenberg
city: Tuebingen
country: Germany
facility: University Medical Center Tuebingen
state: Baden-Würtenberg
city: Munich
country: Germany
facility: Technical University of Munich - Medical Faculty
state: Bavaria
city: Jena
country: Germany
facility: University Medical Center Jena
state: Thueringen
city: Hamburg
country: Germany
facility: University Medical Center Hamburg
Study officials:
affiliation: Director of the Department of Psychosomatic Medicine and Psychotherapy
name: Bernd Löwe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.