protocolSection identificationModule nctId: NCT06298864, orgStudyIdInfo id: ASC-RCT 2, briefTitle: Internet-based Behavioral Intervention Following ACS, acronym: ACS-CBT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: The aim of this study is to evaluate if an online Cognitive Behavioral Therapy (CBT) protocol customized for patients following Acute Coronary Syndrome (ACS), reduce cardiac anxiety, enhance Quality of Life (QoL), and promote increased physical activity while controlling for caregiver attention, utilizing an active control group receiving internet-based cardiac lifestyle intervention., conditionsModule conditions: Acute Coronary Syndrome, conditions: Online CBT Targeting Cardiac Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: Internet-CBT, interventions name: Internet-CL, outcomesModule primaryOutcomes measure: Cardiac anxiety questionnaire modified for weekly assessment, secondaryOutcomes measure: Cardiac anxiety questionnaire, secondaryOutcomes measure: Cardiac anxiety questionnaire, secondaryOutcomes measure: HeartQoL Health-related Quality of Life Questionnaire modified for weekly assessment, secondaryOutcomes measure: HeartQoL Health-related Quality of Life Questionnaire, secondaryOutcomes measure: HeartQoL Health-related Quality of Life Questionnaire, secondaryOutcomes measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease) modified for weekly assessment, secondaryOutcomes measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease), secondaryOutcomes measure: Symptom checklist Severity and Frequency Scale (SCL, adapted to coronary artery disease), secondaryOutcomes measure: University of Toronto Atrial fibrillation Severity Scale (AFSS), secondaryOutcomes measure: University of Toronto Atrial fibrillation Severity Scale (AFSS), secondaryOutcomes measure: University of Toronto Atrial fibrillation Severity Scale (AFSS), secondaryOutcomes measure: Myocardial infarction behavior questionnaire, secondaryOutcomes measure: Myocardial infarction behavior questionnaire, secondaryOutcomes measure: Myocardial infarction behavior questionnaire, secondaryOutcomes measure: DOSE Non-Adherence questionnaire, secondaryOutcomes measure: DOSE Non-Adherence questionnaire, secondaryOutcomes measure: DOSE Non-Adherence questionnaire, secondaryOutcomes measure: Perceived stress scale 4-item, secondaryOutcomes measure: Perceived stress scale 4-item, secondaryOutcomes measure: Perceived stress scale 4-item, secondaryOutcomes measure: Short Fatigue questionnaire, secondaryOutcomes measure: Short Fatigue questionnaire, secondaryOutcomes measure: Short Fatigue questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Insomnia Severity Index, secondaryOutcomes measure: Perceived stress scale 4-item, secondaryOutcomes measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity, secondaryOutcomes measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity, secondaryOutcomes measure: The Godin Leisure-time Exercise and International Physical Activity Questionnaire 1 item on inactivity, secondaryOutcomes measure: Lifestyle factors: The national Board of health and Welfare questionnaire, secondaryOutcomes measure: Lifestyle factors: The national Board of health and Welfare questionnaire, secondaryOutcomes measure: Lifestyle factors: The national Board of health and Welfare questionnaire, secondaryOutcomes measure: Aversive cognition to medication, secondaryOutcomes measure: Adversive cognition to medication, secondaryOutcomes measure: Adversive cognition to medication, otherOutcomes measure: Adverse events, otherOutcomes measure: Adverse events, otherOutcomes measure: Adverse events, otherOutcomes measure: Adverse events, otherOutcomes measure: Accelerometer (Actigraf®), otherOutcomes measure: Accelerometer (Actigraf®), otherOutcomes measure: Swedish Prescribed Drug Register, otherOutcomes measure: Swedish Prescribed Drug Register, otherOutcomes measure: Swedish Prescribed Drug Register, otherOutcomes measure: Working Alliance Inventory, otherOutcomes measure: Treatment Credibility Scale, otherOutcomes measure: Client satisfaction Questionnaire, otherOutcomes measure: Follow-up questions on health changes, otherOutcomes measure: Follow-up questions on health changes, otherOutcomes measure: Follow-up questions on health changes, otherOutcomes measure: AFFS/SCL-4, otherOutcomes measure: MI-behavior Questionnaire, otherOutcomes measure: DOSE Non-Adherence questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska University Hospital, city: Stockholm, zip: 11635, country: Sweden, contacts name: Josefin Särnholm, PhD, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False