Here is the design of a clinical trial:

Official Title: A Personalized and Interactive Web-based Health Care Innovation to AdvanCe the QualIty of Life and CaRE of Patients with an Implantable Cardioverter Defibrillator

Included conditions:
- Implantable Defibrillator User
- Distress

Study Armgroups:
- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Implantable cardioverter defibrillator implant + usual care + supportive care given via an e-health platform. The supportive care consists of information, dialogue with a nurse or psychologist, CBT-based psychological intervention online, quizzes to increase knowledge', 'interventionNames': ['Other: Supportive care']}
- {'label': 'Usual care', 'type': 'NO_INTERVENTION', 'description': 'Implantable cardioverter defibrillator implant + usual care'}

Interventions:
- {'type': 'OTHER', 'name': 'Supportive care', 'description': 'Information, guidance, supportive care, and psychological intervention', 'armGroupLabels': ['Intervention']}

Primary Outcomes:
- {'measure': 'Device acceptance', 'description': 'Measured with the Florida Patient Acceptance Survey (FPAS)', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
Type I error of 0.05 (two-sided), power of 90%, and an estimated loss to follow-up rate of 20%.
Sample size calculation
        Based on historical data from the Web-based Distress Management Program for Implantable Cardioverter Defibrillator (WEBCARE) patients that evaluated the effectiveness of an online behavioural treatment based on problem-solving principles of cognitive behavioural therapy [47, 48], we assume that a difference in device acceptance, as measured by the Florida Patient Acceptance Survey, of 3 points at 12Â months is the minimal clinically relevant difference between treatment groups. We further assume a standard deviation (SD) of 9 points. Targeting the power analysis to these assumptions, with a type I error of 0.05 (two-sided) and a power of 90%, 382 patients need to be evaluable for the primary endpoint. To compensate for loss to follow-up (estimated at 20%), we will aim to randomise a total of 478 patients (239 in each arm).