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

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ClinicalTrials.gov Identifier: NCT03988985
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
Federal Joint Committee, Germany
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Other: Patient-targeted feedback Other: GP-targeted feedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1074 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices: The GET.FEEDBACK.GP Multicentre Randomized Controlled Trial
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : February 18, 2022
Estimated Study Completion Date : April 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

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.

Active Comparator: 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.
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.

No Intervention: NO-FEEDBACK
Using a randomized-controlled study design one third of the patients and their attending general practitioner will not receive any feedback.



Primary Outcome Measures :
  1. Depression severity (Questionnaire: Patient Health Questionnaire-9) [ Time Frame: Six months after screening ]
    Level of depression severity six months after screening (Patient Health Questionnaire-9)


Secondary Outcome Measures :
  1. Depression severity (Questionnaire: Patient Health Questionnaire-9) [ Time Frame: One and twelve months after screening ]
    Level of depression severity one and twelve months after screening (Questionnaire: Patient Health Questionnaire-9)

  2. Depression treatment [ Time Frame: Six and twelve months after screening ]
    Proportion of patients treated according to German Guideline based recommendations

  3. Health economic Evaluation (Questionnaire: Client Sociodemographic and Service Receipt Inventory) [ Time Frame: Six and twelve months after screening ]
    Direct and indirect health costs (Client Sociodemographic and Service Receipt Inventory)

  4. Quality-adjusted life years (Questionnaire: EuroQol-5D) [ Time Frame: Six and twelve months after screening ]
    Quality-adjusted years of life and quality of life (EuroQol-5D)

  5. Anxiety (Questionnaire: Generalized Anxiety Disorder-7) [ Time Frame: One, six and twelve months after screening ]
    Level of anxiety severity one, six and twelve months after screening

  6. Somatic symptom severity (Questionnaire: Somatic Symptom Scale-8) [ Time Frame: One, six and twelve months after screening ]
    Level of somatic symptom severity one, six and twelve months after screening



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988985


Contacts
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Contact: Sebastian Kohlmann, PhD +49 40 7410 54321 s.kohlmann@uke.de
Contact: Bernd Löwe, MD +49 40 7410 53992 b.loewe@uke.de

Locations
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Germany
Technical University of Munich - Medical Faculty Recruiting
Munich, Bavaria, Germany, 80333
Contact: Antonius Schneider, MD    +49 89 / 6146589-11    antonius.schneider@tum.de   
Contact: Klaus Linde, MD       Klaus.Linde@mri.tum.de   
University Medical Center Hamburg Recruiting
Hamburg, Germany, 20246
Contact: Bernd Löwe, MD    +49 40-7410-59733    b.loewe@uke.de   
Contact: Sebastian Kohlmann, PhD    +49 40-7410-54321    s.kohlmann@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Federal Joint Committee, Germany
Investigators
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Principal Investigator: Bernd Löwe, MD Director of the Department of Psychosomatic Medicine and Psychotherapy

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03988985     History of Changes
Other Study ID Numbers: UHHamburgEppendorfGetFeedback
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Depression
Screening
Primary Care
General Practice
Feedback
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders