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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1030 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PATIENT-GP-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.

Group Type EXPERIMENTAL

Patient-targeted feedback

Intervention Type OTHER

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

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

GP-targeted feedback

Intervention Type OTHER

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.

NO-FEEDBACK

Using a randomized-controlled study design one third of the patients and their attending general practitioner will not receive any feedback.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No