Increasing the efficiency of depression-screening using patient-targeted feedback: Randomized controlled trial
Organizational Data
- DRKS-ID:
- DRKS00003277
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2012-07-03
- Last update in DRKS:
- 2023-01-13
- Registration type:
- Retrospective
Acronym/abbreviation of the study
DEPSCREEN-INFO
URL of the study
http://www.uke.de/kliniken/psychosomatik/index_75829.php
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.
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.
Health condition or problem studied
- ICD10:
- F32 - Depressive episode
- ICD10:
- I25 - Chronic ischaemic heart disease
- ICD10:
- I10 - Essential (primary) hypertension
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- state-of-art depression screening plus patient-targeted feedback
- Arm 2:
- state-of-art depression screening
Endpoints
- Primary outcome:
- Level of depression one month after screening (PHQ-9)
- 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.
Study Design
- Purpose:
- Screening
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitaeres Herzzentrum Hamburg-Eppendorf Hamburg
- Doctor's practice Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2012-07-16
- Actual study start date:
- 2011-10-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2014-05-01
- Target Sample Size:
- 3500
- Final Sample Size:
- 4151
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 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
Addresses
Primary Sponsor
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-EppendorfProf. Dr. Dipl.-Psych. Bernd LöweMartinistr. 52D-20246 HamburgGermany
- Telephone:
- +49-40-7410-59733
- Fax:
- +49-40-7410-54975
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de/kliniken/psychosomatik/
Contact for Public Queries
- Address:
- Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-EppendorfProf. Dr. Dipl.-Psych. Bernd LöweMartinistr. 52D-20246 HamburgGermany
- Telephone:
- +49-40-7410-59733
- Fax:
- +49-40-7410-54975
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de/kliniken/psychosomatik/
Principal Investigator
- Address:
- Institut und Poliklinik für Psychosomatische Medizin und Psychotherapie, Universitätsklinikum Hamburg-EppendorfProf. Dr. Dipl.-Psych. Bernd LöweMartinistr. 52D-20246 HamburgGermany
- Telephone:
- +49-40-7410-59733
- Fax:
- +49-40-7410-54975
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de/kliniken/psychosomatik/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-2022990
- Fax:
- +40-40-202299410
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2011-06-13
- Ethics committee number:
- PV 3845
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2011-09-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Löwe B, Blankenberg S, Wegscheider K, König 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. PMID: 27908896.
- Date of first publication of study results:
- 2017-02-01
- DRKS entry published for the first time with results:
- 2023-01-13
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- Background: International guidelines advocate depression screening in patients with coronary heart disease (CHD) and other chronic illnesses, but evidence is lacking. Aims: To test the differential efficacy of written patient-targeted feedback v. no written patient feedback after depression screening. Method: Patients with CHD or hypertension from three cardiology settings were randomised and screened for depression (ClinicalTrials.gov Identifier: NCT01879111). Compared with the control group, where only cardiologists received written feedback, in the intervention group both cardiologists and patients received written feedback regarding depression status. Depression severity was measured 1 month (primary outcome) and 6 months after screening. Results: The control group (n = 220) and the patient-feedback group (n = 155) did not differ in depression severity 1 month after screening. Six months after screening, the patient-feedback group showed significantly greater improvements in depression severity and was twice as likely to seek information about depression compared with the control group. Conclusions: Patient-targeted feedback in addition to screening has a significant but small effect on depression severity after 6 months and may encourage patients to take an active role in the self-management of depression.