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Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback (DEPSCREEN-INFO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01879111
First Posted: June 17, 2013
Last Update Posted: December 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  Purpose
Out-patients with coronary heart disease or hypertension 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 or hypertension.

Condition Intervention
Depressive Episode Chronic Ischaemic Heart Disease Hypertension Other: patient-targeted feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Level of depression one month after screening (Patient Health Questionnaire-9) [ Time Frame: One month after depression screening ]

Secondary Outcome Measures:
  • Level of depression six months after screening (Patient Health Questionnaire-9) [ Time Frame: One month and six months after screening ]
  • Proportion of patients treated for depression. [ Time Frame: One month and six months after screening ]
  • Direct and indirect health costs [ Time Frame: One month and six months after screening ]
  • Quality-adjusted years of life and quality of life (EuroQol-5D) [ Time Frame: One month and six months after screening ]

Enrollment: 4151
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: state-of-art depression screening + patient-targeted feedback
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.
Other: patient-targeted feedback
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.
No Intervention: state-of-art depression screening

Detailed Description:
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) or hypertension. 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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Gender: Both, male and female
  • Minimum Age: 18 Years
  • Maximum Age: no maximum age
  • Attendance in a cardiac clinic;
  • Clinical diagnosis of coronary heart disease or hypertension;
  • Age ≥ 18 years;
  • Sufficient language skills;
  • Informed consent

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
  Contacts and Locations
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): NCT01879111


Locations
Germany
University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf
Hamburg, Germany, 20246
Cardiologicum Hamburg
Hamburg, Germany, 22041
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Bernd Loewe, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01879111     History of Changes
Other Study ID Numbers: 01-GX-1004
DRKS00003277 ( Registry Identifier: German Clinical Trials Register )
First Submitted: June 12, 2013
First Posted: June 17, 2013
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Depressive episode
Chronic ischaemic heart disease
Hypertension

Additional relevant MeSH terms:
Hypertension
Depression
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Depressive Disorder
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Mood Disorders
Mental Disorders