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NCT Number: NCT03988985

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Heidelberg, Heidelberg, Baden-Würtenberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-targeted feedback

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Federal Joint Committee

Registry information

Official study title

Enhancing the Clinical Effectiveness of Depression Screening Using Patient-targeted Feedback in General Practices: The GET.FEEDBACK.GP Multicentre Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2019
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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