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

November 16, 2020 updated by: Universitätsklinikum Hamburg-Eppendorf

Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22041
        • Cardiologicum Hamburg
      • Hamburg, Germany, 20246
        • University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of depression one month after screening (Patient Health Questionnaire-9)
Time Frame: One month after depression screening
One month after depression screening

Secondary Outcome Measures

Outcome Measure
Time Frame
Level of depression six months after screening (Patient Health Questionnaire-9)
Time Frame: One month and six months after screening
One month and six months after screening
Proportion of patients treated for depression.
Time Frame: One month and six months after screening
One month and six months after screening
Direct and indirect health costs
Time Frame: One month and six months after screening
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
One month and six months after screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Bernd Loewe, MD, Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-GX-1004
  • DRKS00003277 (Registry Identifier: German Clinical Trials Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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