- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203395
Screening for Depression and Anxiety in Patients With Heart Disease
December 3, 2019 updated by: Torkil Berge, Diakonhjemmet Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
232
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unable to provide informed consent.
- Unable to read and/or understand Norwegian.
- Unable to complete a survey.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heart patients
Screening and counselling
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 minutes
|
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.
|
1 hour
|
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.
|
1-2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Torkil Berge, Psychologist, Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
June 23, 2017
First Submitted That Met QC Criteria
June 27, 2017
First Posted (Actual)
June 29, 2017
Study Record Updates
Last Update Posted (Actual)
December 4, 2019
Last Update Submitted That Met QC Criteria
December 3, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/16558 (PVO)
- 2016/16558 (Other Identifier: The Data Protection Officer (Personvernombudet))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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