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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03938805
Recruitment Status Completed
First Posted May 6, 2019
Last update posted July 31, 2020
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.
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).
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
Behavioral: Internet-based cognitive behavioral therapy for insomnia
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.
|Active Comparator: Control group
3 weeks internet-based sleep hygiene education
Other: Control group
Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- age over 18 years
- having a clinical diagnose of insomnia
- being treated for heart failure, coronary artery disease or atrial fibrillation
- access to a computer with an Internet connection, access to a mobile phone and was
willing to participate in a treatment for their insomnia.
- no access to internet, computer or cellphone.
- not understanding the Swedish language
- suffering from cognitive disabilities, severe psychiatric disease, severe somatic
disease or sleep apnea
- suffering from drug abuse
- been hospitalised for heart failure, coronary artery disease or atrial fibrillation in
the last four weeks
- expected survival less than 12 months
Principal Investigator: Anders Broström, Professor Jonkoping University