NCT01879111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

June 12, 2013

Last Update Submit

November 16, 2020

Conditions

Depressive EpisodeChronic Ischaemic Heart DiseaseHypertension

Keywords

Depressive episodeChronic ischaemic heart diseaseHypertension

Outcome Measures

Primary Outcomes (1)

  • Level of depression one month after screening (Patient Health Questionnaire-9)

    One month after depression screening

Secondary Outcomes (4)

  • Level of depression six months after screening (Patient Health Questionnaire-9)

    One month and six months after screening

  • Proportion of patients treated for depression.

    One month and six months after screening

  • Direct and indirect health costs

    One month and six months after screening

  • Quality-adjusted years of life and quality of life (EuroQol-5D)

    One month and six months after screening

Study Arms (2)

state-of-art depression screening + patient-targeted feedback

EXPERIMENTAL

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

state-of-art depression screening

NO INTERVENTION

Interventions

patient-targeted feedbackOTHER

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.

state-of-art depression screening + patient-targeted feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Cardiologicum Hamburg

Hamburg, 22041, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27908896DERIVED

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bernd Loewe, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2013

First Posted

June 17, 2013

Study Start

October 1, 2011

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

November 18, 2020

Record last verified: 2020-11

Locations

DE(2)