NCT03938805

I-CBT Tailored to Patients With Cardiovascular Disease and Insomnia

Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Jonkoping University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Insomnia
• Cardiovascular Diseases

Interventions

Type	Name	Description
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.
OTHER	Control group	Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.

Timeline

• Start date: 2017-03-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-05-06
• Last updated: 2020-07-31

Locations

1 site across 1 country: Sweden