Depressive EpisodeDEPSCREEN-INFONCT01879111
Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback
A study testing patient-targeted feedback in people with Depressive Episode and Chronic Ischaemic Heart Disease, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Episode, Chronic Ischaemic Heart Disease, Hypertension
- What is being tested?
- patient-targeted feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,151 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Universitaeres Herzzentrum Hamburg-Eppendorf
Hamburg, 20246
Cardiologicum Hamburg
Hamburg, 22041
About this study
Official title: 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.
Read the 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.
- Being tested
- patient-targeted feedback
- Keywords
- Depressive episode, Chronic ischaemic heart disease, Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: patient-targeted feedback |
| state-of-art depression screening | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depression one month after screening (Patient Health Questionnaire-9)
Measured: One month after depression screening
Secondary outcomes (4)
Level of depression six months after screening (Patient Health Questionnaire-9)
Measured: One month and six months after screening
Proportion of patients treated for depression.
Measured: One month and six months after screening
Direct and indirect health costs
Measured: One month and six months after screening
Quality-adjusted years of life and quality of life (EuroQol-5D)
Measured: One month and six months after screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Bernd Loewe, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879111
- Sponsor's protocol ID
- 01-GX-1004
- Other IDs
- DRKS00003277
- Acronym
- DEPSCREEN-INFO
- Status last verified
- Nov 2020
- First submitted
- 12 Jun 2013
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27908896
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Efficiency of Depression-screening Using Patient-targeted Feedback: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01879111
- Acronym / sponsor ID
- DEPSCREEN-INFO / 01-GX-1004
- Keywords
- Depressive episode, Chronic ischaemic heart disease, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,151 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| state-of-art depression screening + patient-targeted feedback | Experimental | Other: patient-targeted feedbackUsing 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 | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-targeted feedbackUsing 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 | state-of-art depression screening + patient-targeted feedback |
Primary outcome
Level of depression one month after screening (Patient Health Questionnaire-9)
Time frame: One month after depression screening
4 secondary outcomes
Level of depression six months after screening (Patient Health Questionnaire-9)
Time frame: One month and six months after screening
Proportion of patients treated for depression.
Time frame: One month and six months after screening
Direct and indirect health costs
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Derived from this study: PubMed 27908896Lowe 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.
- Website of the Department of Psychosomatic Medicine (in German)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Loewe, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient-targeted feedback in people with Depressive Episode and Chronic Ischaemic Heart Disease, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of depression one month after screening (Patient Health Questionnaire-9) (time frame: One month after depression screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01879111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.