DepressionNCT03203395
Screening for Depression and Anxiety in Patients With Heart Disease
A study testing Screening and counselling in people with Depression and Depressive Symptoms, run by Diakonhjemmet Hospital.
Trial summary
Depression is a risk factor for morbidity and mortality in patients with heart disease, and has a negative impact on quality of life, work capacity and treatment adherence. Screening for depression among heart patients are therefore recommended by the Norwegian Health Authorities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Symptoms, Depressive Disorder
- What is being tested?
- Screening and counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Oct 2017
- 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
- Men and women over 18 years under treatment for myocardial infarction, heart failure, tachyarrhythmia and/or valvular heart disease at the Department of Internal Medicine, Diakonhjemmet Hospital.
Who cannot join
- Unable to provide informed consent.
- Unable to read and/or understand Norwegian.
- Unable to complete a survey.
About this study
Depression is a risk factor for morbidity and mortality in patients with heart disease, and has a negative impact on quality of life, work capacity and treatment adherence. Screening for depression among heart patients are therefore recommended by the Norwegian Health Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear of physical activity and excessive worry. Patients currently receiving treatment for heart disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If such symptoms are detected, patients will be offered a counselling session with a clinical psychologist. Further, routines for collaborative communication between clinical psychologist, cardiologist and the patient's general physician will be emphasized.
- Conditions
- Depression, Depressive Symptoms, Depressive Disorder, Anxiety, Anxiety Disorders, Panic Attacks
- Being tested
- Screening and counselling
- Keywords
- Depression, Anxiety, Panic Attacks, Collaborative Care, Heart disease and depression, Heart disease and anxiety, Heart disease and panic attacks
- Medical subject headings
- Depression, Depressive Disorder, Anxiety Disorders, Panic Disorder, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening and counsellingBehavioural
Screening for symptoms of depression and anxiety in heart patients, giving advice for prevention and managing of such symptoms and stimulating collaborative care between the hospital and the general practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Heart patients | Experimental | Screening and counselling Receives: Behavioral: Screening and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients.
All patients included in the study will be screened for symptoms of depression, anxiety and recent panic attack by filling out a survey consisting of questions from the Patient Health Questionnaire-2 (PHQ-2), the Generalized Anxiety Disorder Scale-2 (GAD-2) and a question about whether they experienced a panic attack in the last four weeks. Cut-off is set to a score of ≥ 2 on PHQ-2 and/or GAD-2 and/or a positive answer on the question about panic attack.
Measured: 15 minutes
Detection of patients with or at risk for depression and/or anxiety disorders.
Patients who screened positive for symptoms of depression, anxiety and/or panic attack will be asked to complete the Hospital Anxiety and Depression Scale (HADS). Patients with a HADS score of ≥ 4 will be offered a counselling session with a clinical psychologist.
Measured: 1 hour
Implementation of counselling for treatment and prevention of depression and anxiety disorders in heart patients.
Patients with a HADS score of ≥ 4 will be offered a counselling session with a clinical psychologist aimed to treat and prevent depression and anxiety disorders in heart patients.
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jan 2017
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Extrastiftelsen, LHL - The Norwegian Heart and Lung Patient Organization
- Responsible party
- Principal investigator, Torkil Berge, Diakonhjemmet Hospital
- Investigators
- Torkil Berge, Psychologist, Principal investigator, Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203395
- Sponsor's protocol ID
- 2016/16558 (PVO)
- Other IDs
- 2016/16558, 2016
- Status last verified
- Dec 2019
- First submitted
- 23 Jun 2017
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Depression and Anxiety in Patients With Heart Disease
- ClinicalTrials.gov ID
- NCT03203395
- Acronym / sponsor ID
- 2016/16558 (PVO)
- Conditions
- Depression, Depressive Symptoms, Depressive Disorder, Anxiety, Anxiety Disorders, Panic Attacks
- Keywords
- Depression, Anxiety, Panic Attacks, Collaborative Care, Heart disease and depression, Heart disease and anxiety, Heart disease and panic attacks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Extrastiftelsen, LHL - The Norwegian Heart and Lung Patient Organization
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 29 Jun 2017 (actual)
- 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.
Depression is a risk factor for morbidity and mortality in patients with heart disease, and has a negative impact on quality of life, work capacity and treatment adherence. Screening for depression among heart patients are therefore recommended by the Norwegian Health Authorities. Also, symptoms of anxiety may negatively affect rehabilitation due to e.g. fear of physical activity and excessive worry. Patients currently receiving treatment for heart disease at Diakonhjemmet Hospital will be screened for symptoms of depression and anxiety. If such symptoms are detected, patients will be offered a counselling session with a clinical psychologist. Further, routines for collaborative communication between clinical psychologist, cardiologist and the patient's general physician will be emphasized.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart patients | Experimental | Behavioral: Screening and counsellingScreening and counselling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women over 18 years under treatment for myocardial infarction, heart failure, tachyarrhythmia and/or valvular heart disease at the Department of Internal Medicine, Diakonhjemmet Hospital.
Key exclusion criteria (3 listed)
- Unable to provide informed consent.
- Unable to read and/or understand Norwegian.
- Unable to complete a survey.
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 |
|---|---|---|
| Screening and counsellingScreening for symptoms of depression and anxiety in heart patients, giving advice for prevention and managing of such symptoms and stimulating collaborative care between the hospital and the general practitioner. | Behavioural | Heart patients |
Primary outcome
Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients.
Time frame: 15 minutes
All patients included in the study will be screened for symptoms of depression, anxiety and recent panic attack by filling out a survey consisting of questions from the Patient Health Questionnaire-2 (PHQ-2), the Generalized Anxiety Disorder Scale-2 (GAD-2) and a question about whether they experienced a panic attack in the last four weeks. Cut-off is set to a score of ≥ 2 on PHQ-2 and/or GAD-2 and/or a positive answer on the question about panic attack.
Detection of patients with or at risk for depression and/or anxiety disorders.
Time frame: 1 hour
Patients who screened positive for symptoms of depression, anxiety and/or panic attack will be asked to complete the Hospital Anxiety and Depression Scale (HADS). Patients with a HADS score of ≥ 4 will be offered a counselling session with a clinical psychologist.
Implementation of counselling for treatment and prevention of depression and anxiety disorders in heart patients.
Time frame: 1-2 hours
Patients with a HADS score of ≥ 4 will be offered a counselling session with a clinical psychologist aimed to treat and prevent depression and anxiety disorders in heart patients.
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 4 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Torkil Berge, Psychologist principal investigator
Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
Questions about this trial
What is this clinical trial studying?
A study testing Screening and counselling in people with Depression and Depressive Symptoms, run by Diakonhjemmet Hospital.
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 1 inclusion and 3 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients. (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2019.