Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback (DEPSCREEN-INFO)
Primary Purpose
Depressive Episode, Chronic Ischaemic Heart Disease, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
patient-targeted feedback
Sponsored by
About this trial
This is an interventional screening trial for Depressive Episode focused on measuring Depressive episode, Chronic ischaemic heart disease, Hypertension
Eligibility 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
Sites / Locations
- University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf
- Cardiologicum Hamburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
state-of-art depression screening + patient-targeted feedback
state-of-art depression screening
Arm Description
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.
Outcomes
Primary Outcome Measures
Level of depression one month after screening (Patient Health Questionnaire-9)
Secondary Outcome Measures
Level of depression six months after screening (Patient Health Questionnaire-9)
Proportion of patients treated for depression.
Direct and indirect health costs
Quality-adjusted years of life and quality of life (EuroQol-5D)
Full Information
NCT ID
NCT01879111
First Posted
June 12, 2013
Last Updated
November 16, 2020
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01879111
Brief Title
Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback
Acronym
DEPSCREEN-INFO
Official Title
Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episode, Chronic Ischaemic Heart Disease, Hypertension
Keywords
Depressive episode, Chronic ischaemic heart disease, Hypertension
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
state-of-art depression screening + patient-targeted feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
state-of-art depression screening
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
patient-targeted feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of depression one month after screening (Patient Health Questionnaire-9)
Time Frame
One month after depression screening
Secondary Outcome Measure Information:
Title
Level of depression six months after screening (Patient Health Questionnaire-9)
Time Frame
One month and six months after screening
Title
Proportion of patients treated for depression.
Time Frame
One month and six months after screening
Title
Direct and indirect health costs
Time Frame
One month and six months after screening
Title
Quality-adjusted years of life and quality of life (EuroQol-5D)
Time Frame
One month and six months after screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Loewe, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Cardiologicum Hamburg
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27908896
Citation
Lowe B, Blankenberg S, Wegscheider K, Konig HH, Walter D, Murray AM, Gierk B, Kohlmann S. Depression screening with patient-targeted feedback in cardiology: DEPSCREEN-INFO randomised clinical trial. Br J Psychiatry. 2017 Feb;210(2):132-139. doi: 10.1192/bjp.bp.116.184168. Epub 2016 Dec 1.
Results Reference
derived
Links:
URL
https://www.uke.de/kliniken-institute/kliniken/psychosomatische-medizin-und-psychotherapie/forschung/arbeitsgruppen/ag_koerperliche-erkrankungen.html
Description
Website of the Department of Psychosomatic Medicine (in German)
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Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback
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