Clinical trial NCT01879111: Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback
Official title: Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Episode
Chronic Ischaemic Heart Disease
Hypertension
Keywords: Depressive episode
Chronic ischaemic heart disease
Hypertension
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-06-17
Enrollment: 4151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Level of depression one month after screening (Patient Health Questionnaire-9)
timeFrame: One month after depression screening
Secondary outcomes:
measure: Level of depression six months after screening (Patient Health Questionnaire-9)
timeFrame: One month and six months after screening
measure: Proportion of patients treated for depression.
timeFrame: One month and six months after screening
measure: Direct and indirect health costs
timeFrame: One month and six months after screening
measure: Quality-adjusted years of life and quality of life (EuroQol-5D)
timeFrame: One month and six months after screening
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Bernd Loewe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.