An interventional study of Cognitive Behavioural Therapy for insomnia (CBT-I) and Sleep Hygiene Advice in Insomnia Chronic and Coronary Heart Disease, sponsored by Vestre Viken Hospital Trust. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Vestre Viken Hospital Trust · Not applicable, Interventional, and Treatment
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 76 is close to the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Vestre Viken Hospital Trust is the lead sponsor of 51 studies on the registry; 22 are open to participants now.
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Exclusion criteria (any of the following):
Other: Cognitive Behavioural Therapy for insomnia (CBT-I)
Other: Sleep Hygiene Advice
Five 60-90 minutes weekly sessions delivered by an appropriately trained cardiac nurse at a cardiology department. The CBT-I intervention will follow a manualized treatment protocol developed by Espie and colleagues (Espie et al. 2001, 2007, 2008) and evaluated in a number of published RCTs using CBT-I. The key components of this intervention include sleep hygiene advice, stimulus control, sleep restriction, relaxation training, and cognitive restructuring.
"Sleep well" is a 16-page written brochure developed by the Directorate of Health in Norway for dissemination to patients with sleep problems including insomnia. It covers general sleep hygiene advice (setting a regular bed-time, avoiding stimulants, alcohol and exercise in the evening, sleeping in a quiet bedroom, advice of practicing relaxation technique and postpone worries).
Remission clinical diagnosis of insomnia
Between- and within- group differences in the proportion witn remission of insomnia diagnosis assessed by the Bergen Insomnia Scale
Time frame: From baseline to weeks 6-8 and 26
Changes in insomnia severity
Between- and within- group differences in insomnia severity assessed by the Insomnia Severity Index
Time frame: From baseline to weeks 6-8 and 26
Changes in insomnia assessed by the Pittsburgh Sleep Quality Index
Between- and within- group differences in insomnia assessed by the Pittsburgh Sleep Quality Index with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in subjective sleep efficiency
Between- and within- group differences in sleep efficiency assessed by a self-report sleep diary with higher scores indicating better outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in objective sleep efficiency
Between- and within- group differences in sleep efficiency assessed by an assessed by an actigraph with higher scores indicating better outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in subjective total sleep time
Between- and within- group differences in total sleep time assessed by a self-report sleep diary with higher scores indicating better outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in objective total sleep time
Between- and within- group differences in total sleep time assessed by an assessed by an actigraph with higher scores indicating better outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in subjective sleep onset latency
Between- and within- group differences in sleep onset latency assessed by a self-report sleep diary with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in objective sleep onset latency
Between- and within- group differences in sleep onset latency assessed by an assessed by an actigraph with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in subjective wake after sleep onset
Between- and within- group differences in wake after sleep onset assessed by a self-report sleep diary with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in objective wake after sleep onset
Between- and within- group differences in wake after sleep onset assessed by an assessed by an actigraph with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in symptoms of depression and anxiety
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
Time frame: From baseline to weeks 6-8 and 26
Changes in daytime sleepiness
Between- and within- group differences in daytime sleepiness assessed by the Epworth Sleepiness Scale with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in fatigue
Between- and within- group differences in fatigue assessed by the Chalder Fatigue Scale with higher scores indicating worse outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in general quality of life
Between- and within- group differences in quality of life assessed by the 5-level EQ-5D version with higher scores indicating better outcomes
Time frame: From baseline to weeks 6-8 and 26
Changes in sleep-related quality of life
Between- and within- group differences in sleep-related quality of life assessed by the Glasgow Sleep Impact Scale with higher scores indicating better outcomes
Time frame: From baseline to weeks 6-8 and 26
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Vestre Viken Hospital Trust