Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices
- Conditions
- Depression
- Interventions
- Other: Patient-targeted feedbackOther: GP-targeted feedback
- Registration Number
- NCT03988985
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1030
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description PATIENT-GP-FEEDBACK Patient-targeted 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. GP-FEEDBACK GP-targeted 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. PATIENT-GP-FEEDBACK GP-targeted 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.
- Primary Outcome Measures
Name Time Method Depression severity (Questionnaire: Patient Health Questionnaire-9) Six months after screening Level of depression severity six months after screening (Patient Health Questionnaire-9)
- Secondary Outcome Measures
Name Time Method Depression severity (Questionnaire: Patient Health Questionnaire-9) One and twelve months after screening Level of depression severity one and twelve months after screening (Questionnaire: Patient Health Questionnaire-9)
Anxiety (Questionnaire: Generalized Anxiety Disorder-7) One, six and twelve months after screening Level of anxiety severity one, six and twelve months after screening
Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory) Six and twelve months after screening Direct and indirect health costs (Client Sociodemographic and Service Receipt Inventory)
Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8) One, six and twelve months after screening Level of somatic symptom severity one, six and twelve months after screening
Depression treatment Six and twelve months after screening Proportion of patients treated according to German Guideline based recommendations
Quality-adjusted life years (Questionnaire: EuroQol-5D) Six and twelve months after screening Quality-adjusted years of life and quality of life (EuroQol-5D)
Trial Locations
- Locations (5)
University Medical Center Hamburg
🇩🇪Hamburg, Germany
Technical University of Munich - Medical Faculty
🇩🇪Munich, Bavaria, Germany
University Medical Center Jena
🇩🇪Jena, Thueringen, Germany
University Medical Center Heidelberg
🇩🇪Heidelberg, Baden-Würtenberg, Germany
University Medical Center Tuebingen
🇩🇪Tuebingen, Baden-Würtenberg, Germany