An interventional study of Internet-based cognitive behavioral therapy for insomnia and Control group in Insomnia and Cardiovascular Diseases, sponsored by Jonkoping University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by Jonkoping University · Not applicable, Interventional, and Treatment
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).
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 48 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion criteria:
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
3 weeks internet-based sleep hygiene education
Other: Control group
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.
Also known as: Internet-based CBT
Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.
Insomnia severity index (ISI)
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.
Time frame: 12 months
Short Form 12 (SF-12)
The Short Form 12 Health Survey is a self-assessment questionnaire that measures the respondents quality of life through 12 questions. The 12 items are rated on a 5-point Likert scale, and 2 component scale scores (i.e., the physical component scale and the mental component scale) will be computed.
Time frame: 12 months
Plan to share: No — Sleep (Pittsburg Sleep Quality Index, Insomnia Severity Index, sleep diary), depressive- and cardiac symptoms (Patient Health Qurestionnaire-9, Cardiac Anxiety Questionnaire) and Quality of Life (SF-12) at baseline, during and after intervention (after 6 and 12 months).
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Jonkoping University