Depression
Conditions
Keywords
Depression, Screening, Primary Care, General Practice, Feedback
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.
Interventions
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.
OTHERGP-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
Federal Joint Committee
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity (Questionnaire: Patient Health Questionnaire-9) | Six months after screening | Level of depression severity six months after screening (Patient Health Questionnaire-9) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression treatment | Six and twelve months after screening | Proportion of patients treated according to German Guideline based recommendations |
| 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) |
| 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 |
| 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 |
| Quality-adjusted life years (Questionnaire: EuroQol-5D) | Six and twelve months after screening | Quality-adjusted years of life and quality of life (EuroQol-5D) |
Countries
Germany
Outcome results
None listed