Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-07 @ 9:19 PM
Study NCT ID:
NCT02713360
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ICD Shock', 'timeFrame': '16 weeks and 12 months', 'description': 'The number of ICD shocks will be evaluated within the 16 weeks and the data will be aggregated from the Danish Pacemaker \\& ICD Register.'}, {'measure': 'Time to first schock', 'timeFrame': '16 weeks and 12 months', 'description': 'Time to first schock will be measured within the 16 weeks in number of days and the data will be aggregated from the Danish Pacemaker \\& ICD Register.'}, {'measure': 'Anti tachycardia pacing (ATP)', 'timeFrame': '16 weeks and 12 months', 'description': 'The number of ATP will be evaluated within the 16 weeks and the data will be aggregated from the Danish Pacemaker \\& ICD Register.'}, {'measure': 'Sleep quality', 'timeFrame': '16 weeks and 12 months', 'description': "Patients' own evaluation of sleep quality at 16 weeks and 12 months."}, {'measure': 'Physical activity', 'timeFrame': '16 weeks and 12 months', 'description': "Patients' own evaluation of physical activity at 16 weeks and 12 months."}, {'measure': 'Alcohol', 'timeFrame': '16 weeks and 12 months', 'description': 'Number of alcohol units per week.'}, {'measure': 'Smoking', 'timeFrame': '16 weeks and 12 months', 'description': 'Number of cigarettes per day.'}, {'measure': 'Weight', 'timeFrame': '16 weeks and 12 months', 'description': 'Weight in kilogram.'}], 'primaryOutcomes': [{'measure': 'Primary outcome is anxiety measured by HADS.', 'timeFrame': '16 weeks', 'description': 'HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.\n\nScores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.'}], 'secondaryOutcomes': [{'measure': 'Anxiety measured by HADS.', 'timeFrame': '12 months', 'description': 'HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.\n\nScores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.'}, {'measure': 'Becks Anxiety Inventory (BAI)', 'timeFrame': '16 weeks and 12 months', 'description': 'Becks Anxiety Inventory is a brief self-reported measure of anxiety with a focus on somatic symptoms of anxiety and was developed as a measure to discriminate between anxiety and depression. Respondents indicated how much each symptom has bothered them during the past week on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely). The BAI score ranges from 0-63.'}, {'measure': 'Hamilton Anxiety Scale (HAM-A)', 'timeFrame': '16 weeks and 12 months', 'description': 'Hamilton Anxiety Scale is a clinical interview rating scale of the psychic (mental agitation and psychological distress) and somatic (physical complaints related to anxiety) aspects of anxiety. The scale consists of 14 clinical symptoms that are rated on a 5-point Likert scale ranging from 0 (not present) to 4 (very severe).'}, {'measure': 'HeartQoL', 'timeFrame': '16 weeks and 12 months', 'description': 'The questionnaire measures health-related quality of life in patients with ischemic heart disease, specifically angina, myocardial infarction or ischemic heart failure. The questionnaire consists of 14 items and provides two subscales; a 10-item physical subscale and a 4-item emotional subscale which are scored from 0 to 3.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ICD', 'Cognitive Therapy', 'Anxiety']}, 'referencesModule': {'references': [{'pmid': '27798030', 'type': 'DERIVED', 'citation': 'Berg SK, Herning M, Svendsen JH, Christensen AV, Thygesen LC. The Screen-ICD trial. Screening for anxiety and cognitive therapy intervention for patients with implanted cardioverter defibrillator (ICD): a randomised controlled trial protocol. BMJ Open. 2016 Oct 21;6(10):e013186. doi: 10.1136/bmjopen-2016-013186.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention.\n\nThe aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and (ii) to investigate the effect of screening followed by randomisation to intervention with consultations based on cognitive therapeutic principals to reduce anxiety in patients with ICD or usual care.', 'detailedDescription': 'Screen-ICD is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.\n\nThe intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy. The intervention consists of three steps: 1. The intervention begins with a consultation with a nurse aiming at uncovering anxiety using the Hamilton anxiety scale and exploring how life with an ICD is perceived, 2. Based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided and 3. After each session participants are asked to fill out the HADS questionnaire. When the patient scores below the cut-off value two times in a row, sessions will end. Each patient can have a maximum of 15 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years\n* Have had ICD implantation\n* Speaks and understands Danish\n* Scores 8 or more in the HADS-A questionnaire\n* Gives written informed consent\n\nExclusion Criteria:\n\n* Scores 11 or more in the HADS-D questionnaire and the depression score exceeds the anxiety score.'}, 'identificationModule': {'nctId': 'NCT02713360', 'briefTitle': 'Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) - Screen-ICD', 'orgStudyIdInfo': {'id': 'Screen-ICD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive therapy', 'description': 'The intervention consists of 3 steps. 1: Consultation with a nurse that aims of identifying what the anxiety consist of and how the patient experiences his or her life situation with an ICD. A plan is made to structure the treatment. 2: Participation in an individualized intervention based on anxiety type specific protocols. 3. The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.', 'interventionNames': ['Behavioral: Cognitive Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'The control group will receive usual care which consists of control of ICD, disease control and treatment, and at one of the sites an offer of a group information meeting where experiences and events with ICD are discussed. The meeting takes place at Rigshospitalet every other month.'}], 'interventions': [{'name': 'Cognitive Therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Cognitive therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Selina K. Berg, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior reseacher', 'investigatorFullName': 'Selina Kikkenborg Berg', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}