Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-22 @ 2:47 PM
Study NCT ID:
NCT03203395
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2017-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening for Depression and Anxiety in Patients With Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2017-06-23', 'studyFirstSubmitQcDate': '2017-06-27', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of symptoms of depression, anxiety and/or recent panic attack in heart patients.', 'timeFrame': '15 minutes', '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.'}, {'measure': 'Detection of patients with or at risk for depression and/or anxiety disorders.', 'timeFrame': '1 hour', '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.'}, {'measure': 'Implementation of counselling for treatment and prevention of depression and anxiety disorders in heart patients.', 'timeFrame': '1-2 hours', '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Anxiety', 'Panic Attacks', 'Collaborative Care', 'Heart disease and depression', 'Heart disease and anxiety', 'Heart disease and panic attacks'], 'conditions': ['Depression', 'Depressive Symptoms', 'Depressive Disorder', 'Anxiety', 'Anxiety Disorders', 'Panic Attacks', 'Heart Diseases', 'Collaboration']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Unable to read and/or understand Norwegian.\n* Unable to complete a survey.'}, 'identificationModule': {'nctId': 'NCT03203395', 'briefTitle': 'Screening for Depression and Anxiety in Patients With Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Diakonhjemmet Hospital'}, 'officialTitle': 'Screening for Depression and Anxiety in Patients With Heart Disease', 'orgStudyIdInfo': {'id': '2016/16558 (PVO)'}, 'secondaryIdInfos': [{'id': '2016/16558', 'type': 'OTHER', 'domain': 'The Data Protection Officer (Personvernombudet)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart patients', 'description': 'Screening and counselling', 'interventionNames': ['Behavioral: Screening and counselling']}], 'interventions': [{'name': 'Screening and counselling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Heart patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Torkil Berge, Psychologist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychiatry, Diakonhjemmet Hospital, Oslo, Norway'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Extrastiftelsen', 'class': 'OTHER'}, {'name': 'LHL - The Norwegian Heart and Lung Patient Organization', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Development Counselor', 'investigatorFullName': 'Torkil Berge', 'investigatorAffiliation': 'Diakonhjemmet Hospital'}}}}