Internet-based Cognitive Behavioural Therapy Program Tailored to Patients With Cardiovascular Disease and Insomnia - Effects of a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Jonkoping University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Insomnia severity index (ISI)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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).
Investigators
Anders Broström
Professor
Jonkoping University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Insomnia severity index (ISI)
Time Frame: 12 months
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.
Secondary Outcomes
- Short Form 12 (SF-12)(12 months)