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Screening for Depression and Anxiety in Patients With Heart Disease

Primary Purpose

Depression, Depressive Symptoms, Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Screening and counselling
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Depression focused on measuring Depression, Anxiety, Panic Attacks, Collaborative Care, Heart disease and depression, Heart disease and anxiety, Heart disease and panic attacks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Heart patients

    Arm Description

    Screening and counselling

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 23, 2017
    Last Updated
    December 3, 2019
    Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Extrastiftelsen, LHL - The Norwegian Heart and Lung Patient Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03203395
    Brief Title
    Screening for Depression and Anxiety in Patients With Heart Disease
    Official Title
    Screening for Depression and Anxiety in Patients With Heart Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    October 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diakonhjemmet Hospital
    Collaborators
    Extrastiftelsen, LHL - The Norwegian Heart and Lung Patient Organization

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Depressive Symptoms, Depressive Disorder, Anxiety, Anxiety Disorders, Panic Attacks, Heart Diseases, Collaboration
    Keywords
    Depression, Anxiety, Panic Attacks, Collaborative Care, Heart disease and depression, Heart disease and anxiety, Heart disease and panic attacks

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    232 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Heart patients
    Arm Type
    Experimental
    Arm Description
    Screening and counselling
    Intervention Type
    Behavioral
    Intervention Name(s)
    Screening and counselling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients.
    Description
    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.
    Time Frame
    15 minutes
    Title
    Detection of patients with or at risk for depression and/or anxiety disorders.
    Description
    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.
    Time Frame
    1 hour
    Title
    Implementation of counselling for treatment and prevention of depression and anxiety disorders in heart patients.
    Description
    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.
    Time Frame
    1-2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Torkil Berge, Psychologist
    Organizational Affiliation
    Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Screening for Depression and Anxiety in Patients With Heart Disease

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