Trial document





This trial has been registered retrospectively.
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  DRKS00003277

Trial Description

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Title

Increasing the efficiency of depression-screening using patient-targeted feedback: Randomized controlled trial

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Trial Acronym

DEPSCREEN-INFO

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URL of the Trial

http://www.uke.de/kliniken/psychosomatik/index_75829.php

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Brief Summary in Lay Language

Out-patients with coronary heart disease will fill out a depression screening questionnaire while waiting in a cardiac clinic. Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment. Patients in the control group receive no direct screening-feedback but their cardiologist will be informed about the screening result. All patients with a positive screening-result will be contacted after one month and six months and asked for symptoms of depression, and their use of health care. The aim of this study is to evaluate the efficiency of this minimal intervention on the course of depressive symptom in patients with known coronary heart disease.

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Brief Summary in Scientific Language

The aim of this study is to evaluate the efficiency of a minimal intervention on the course of depressive symptoms in patients with known coronary heart disease (CHD). By means of a depression screening and individual patient-targeted feedback the level of depression should decrease, the percentage of treated depressed patients should increase and health economic costs should be lowered. The main hypothesis is that screening plus targeted feedback results in a greater reduction of depression than screening only.

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Organizational Data

  •   DRKS00003277
  •   2012/07/03
  •   [---]*
  •   yes
  •   Approved
  •   PV 3845, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   I25 -  Chronic ischaemic heart disease
  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   state-of-art depression screening plus patient-targeted feedback
  •   state-of-art depression screening
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Characteristics

  •   Non-interventional
  •   Other
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Level of depression one month after screening (PHQ-9)

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Secondary Outcome

Level of depression six months after screening (PHQ-9); Proportion of patients treated for depression, direct and indirect health costs, quality-adjusted years of life and quality of life (EQ-5D) one month and six months after screening.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/10/01
  •   3500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Attendance in a cardiac clinic;
Clinical diagnosis of coronary heart disease or hypertension;
Age ≥ 18 years;
Sufficient language skills;
Informed consent

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Exclusion Criteria

Life threatening health status;
Severe somatic or/and psychological disorder that needs urgent treatment;
Acute suicidal tendency;
Severe cognitive or/and visual difficulties;
Not being able to fill out questionnaires

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Addresses

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. Dipl.-Psych.  Bernd   Löwe 
    • Martinistr. 52
    • D-20246  Hamburg
    • Germany
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    • Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. Dipl.-Psych.  Bernd   Löwe 
    • Martinistr. 52
    • D-20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/05/01
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Trial Publications, Results and other Documents

  •   [---]*
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* This entry means the parameter is not applicable or has not been set.