Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-03 @ 9:16 PM
Study NCT ID:
NCT03938805
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2019-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single blinded (PI). The randomization is performed by a study team member who was blinded to screening and baseline data. The physician who assessed the patients had access to them in a random sequence. Patients were randomized 1.1 to nine-week internet-based cognitive behavioral therapy (intervention group) or online 3 weeks sleep hygiene (control group) generated by an independent researcher using a block size of two. Masking of patients was not possible since the interventions is a internet-based cognitive behavioral therapy program. Outcome measures were not necessary to mask since these were automatically collected via the study platform.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial. The intervention group participated in a nine-week internet-based cognitive behavioral therapy program. The initial parts of the program, focusing on cardiovascular disease was initially tailored to fit patients with heart failure and has undergone pilot testing. The intervention program used in the current study was adapted to fit also patient with other cardiovascular diagnoses (i.e., heart failure, myocardial infarction, atrial fibrillation) and comprise 1-week of introduction, 2 weeks psycho education on cardiovascular diseases/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction. The Control Group receive 3 weeks of internet-based sleep hygiene education.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insomnia severity index (ISI)', 'timeFrame': '12 months', 'description': 'The Insomnia severity index is a self-assessment questionnaire that measure the perceived severity of insomnia symptoms such as, falling asleep, staying asleep, numbers of awakenings, early awakening, sleep satisfaction. The scale includes of seven items, scored on a 0- 4 scale that are summed to a range of 0 - 28. The score can be divided into four categories: no clinical insomnia (0-7), subthreshold insomnia (8-14), clinical insomnia of moderate severity (15-21), and severe clinical insomnia (22-28). The total score and the categories will be used.'}], 'secondaryOutcomes': [{'measure': 'Short Form 12 (SF-12)', 'timeFrame': '12 months', 'description': 'The Short Form 12 Health Survey is a self-assessment questionnaire that measures the respondents quality of life through 12 questions. The 12 items are rated on a 5-point Likert scale, and 2 component scale scores (i.e., the physical component scale and the mental component scale) will be computed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '33609425', 'type': 'DERIVED', 'citation': 'Siebmanns S, Johansson P, Ulander M, Johansson L, Andersson G, Brostrom A. The effect of nurse-led Internet-based cognitive behavioural therapy for insomnia on patients with cardiovascular disease: A randomized controlled trial with 6-month follow-up. Nurs Open. 2021 Jul;8(4):1755-1768. doi: 10.1002/nop2.817. Epub 2021 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The Hit-IT study is based on an internet-based cognitive behavioral therapy program tailored to patients with different types of cardiovascular diseases and insomnia. A randomized controlled trial design is used. A 9 weeks internet-based cognitive behavioral therapy intervention vs a 3 weeks sleep hygiene education.', 'detailedDescription': 'DESIGN: Randomized controlled trial with 1-year follow-up. All patients with cardiovascular disease (i.e., myocardial infarction, heart failure, atrial fibrillation and angina) from 4 primary care centers will be screened for insomnia and during a clinical examination diagnosed by a physician specialized in sleep medicine. INTERVENTION: 9 weeks internet-based cognitive behavioral therapy for insomnia (1 week introduction, 2 weeks psycho education on cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction) vs 3 weeks internet-based sleep hygiene education. QUESTIONNAIRES: Sleep (Pittsburgh Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Questionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* age over 18 years\n* having a clinical diagnose of insomnia\n* being treated for heart failure, coronary artery disease or atrial fibrillation\n* access to a computer with an Internet connection, access to a mobile phone and was willing to participate in a treatment for their insomnia.\n\nExclusion criteria:\n\n* no access to internet, computer or cellphone.\n* not understanding the Swedish language\n* suffering from cognitive disabilities, severe psychiatric disease, severe somatic disease or sleep apnea\n* suffering from drug abuse\n* been hospitalised for heart failure, coronary artery disease or atrial fibrillation in the last four weeks\n* expected survival less than 12 months'}, 'identificationModule': {'nctId': 'NCT03938805', 'acronym': 'Hit-IT', 'briefTitle': 'I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia', 'organization': {'class': 'OTHER', 'fullName': 'Jonkoping University'}, 'officialTitle': 'Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2015/258-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I-CBT', 'description': 'Internet-based cognitive behavioral therapy program including 1-week introduction, 2 weeks psycho education on Cardiovascular disease/insomnia, 6 weeks of sleep hygiene, stimulus control and sleep restriction', 'interventionNames': ['Behavioral: Internet-based cognitive behavioral therapy for insomnia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '3 weeks internet-based sleep hygiene education', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Internet-based cognitive behavioral therapy for insomnia', 'type': 'BEHAVIORAL', 'otherNames': ['Internet-based CBT'], 'description': 'Patients will be provided with psycho education on different cardiovascular diseases, sleep, insomnia, and provided with different behavioral techniques to improve their sleep. The participants in the intervention Group who receives the Internet-based cognitive behavioral therapy program will also have access to support given by a nurse specialized in sleep. A module is given each week during the 9-week intervention.', 'armGroupLabels': ['I-CBT']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '553 18', 'city': 'Jönköping', 'country': 'Sweden', 'facility': 'Jönköping University', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}], 'overallOfficials': [{'name': 'Anders Broström, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonkoping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sleep (Pittsburg Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Qurestionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonkoping University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anders Broström', 'investigatorAffiliation': 'Jonkoping University'}}}}