Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
- Conditions
- Insomnia ChronicCoronary Heart Disease
- Registration Number
- NCT06749951
- Lead Sponsor
- Vestre Viken Hospital Trust
- Brief Summary
Insomnia is prevalent (45%) in CHD patients and associated with significantly increased risk for recurrent cardiovascular events. Insomnia has recently been identified as the third most important risk factor for prognosis. However, very few insomnia patients are identified and receive treatment of insomnia today. CBT-I is the first-line treatment for insomnia, but studies on the effects in CHD patients are lacking. This project aims to document the effectiveness of Cognitive Behavioural therapy for insomnia (CBT-I) in an outpatient population with coronary heart disease (CHD). Furthermore, the biological and psychological mechanisms that may mediate the effects of the intervention will be identified. Finally, a health-economic simulation and a qualitative study of the participants experiences with CBT-I will be performed. This prospective, randomized, intervention study will continue until data have been collected for the primary outcome on 66 CHD outpatients with a diagnosis of insomnia assessed by Bergen Insomnia Scale (BIS). Participants will be randomised to a short, nurse-administered, CBT-I delivered in a group format or to sleep hygiene advice. The primary outcome will be remission from BIS-insomnia post-treatment and at 6-months follow-up. Secondary outcomes will be changes in insomnia severity, objective and subjective sleep parameters, daytime symptoms of insomnia, and quality of life. Exploratory outcomes include inflammation, cortisol, HbA1C, and cognitions/metacognitions. The project may document the effectiveness of CBT-I for a large patient-group with potentially favorable long-term effects on important clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Remission clinical diagnosis of insomnia From baseline to weeks 6-8 and 26 Between- and within- group differences in the proportion witn remission of insomnia diagnosis assessed by the Bergen Insomnia Scale
Changes in insomnia severity From baseline to weeks 6-8 and 26 Between- and within- group differences in insomnia severity assessed by the Insomnia Severity Index
- Secondary Outcome Measures
Name Time Method Changes in subjective sleep efficiency From baseline to weeks 6-8 and 26 Between- and within- group differences in sleep efficiency assessed by a self-report sleep diary with higher scores indicating better outcomes
Changes in objective sleep efficiency From baseline to weeks 6-8 and 26 Between- and within- group differences in sleep efficiency assessed by an assessed by an actigraph with higher scores indicating better outcomes
Changes in subjective total sleep time From baseline to weeks 6-8 and 26 Between- and within- group differences in total sleep time assessed by a self-report sleep diary with higher scores indicating better outcomes
Changes in objective total sleep time From baseline to weeks 6-8 and 26 Between- and within- group differences in total sleep time assessed by an assessed by an actigraph with higher scores indicating better outcomes
Changes in insomnia assessed by the Pittsburgh Sleep Quality Index From baseline to weeks 6-8 and 26 Between- and within- group differences in insomnia assessed by the Pittsburgh Sleep Quality Index with higher scores indicating worse outcomes
Changes in subjective sleep onset latency From baseline to weeks 6-8 and 26 Between- and within- group differences in sleep onset latency assessed by a self-report sleep diary with higher scores indicating worse outcomes
Changes in objective sleep onset latency From baseline to weeks 6-8 and 26 Between- and within- group differences in sleep onset latency assessed by an assessed by an actigraph with higher scores indicating worse outcomes
Changes in subjective wake after sleep onset From baseline to weeks 6-8 and 26 Between- and within- group differences in wake after sleep onset assessed by a self-report sleep diary with higher scores indicating worse outcomes
Changes in objective wake after sleep onset From baseline to weeks 6-8 and 26 Between- and within- group differences in wake after sleep onset assessed by an assessed by an actigraph with higher scores indicating worse outcomes
Changes in symptoms of depression and anxiety From baseline to weeks 6-8 and 26 Between- and within- group differences in symptoms of depression and anxiety assessed by the Hospital and Anxiety Depression Scale with higher scores indicating worse outcomes
Changes in daytime sleepiness From baseline to weeks 6-8 and 26 Between- and within- group differences in daytime sleepiness assessed by the Epworth Sleepiness Scale with higher scores indicating worse outcomes
Changes in fatigue From baseline to weeks 6-8 and 26 Between- and within- group differences in fatigue assessed by the Chalder Fatigue Scale with higher scores indicating worse outcomes
Changes in general quality of life From baseline to weeks 6-8 and 26 Between- and within- group differences in quality of life assessed by the 5-level EQ-5D version with higher scores indicating better outcomes
Changes in sleep-related quality of life From baseline to weeks 6-8 and 26 Between- and within- group differences in sleep-related quality of life assessed by the Glasgow Sleep Impact Scale with higher scores indicating better outcomes
Related Research Topics
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Trial Locations
- Locations (1)
Vestre Viken Trust Drammen hospital
🇳🇴Drammen, Buskerud, Norway