Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease A Randomized Controlled Trial With Six Months Follow-up

What this Trial Is About

Insomnia is common among patients with coronary heart disease (CHD) and is linked to a higher risk of recurrent heart problems. It has recently been recognized as an important risk factor for health outcomes in CHD patients. However, many insomnia cases remain undiagnosed and untreated. This research aims to evaluate the effectiveness of Cognitive Behavioural Therapy for Insomnia (CBT-I) in CHD outpatients diagnosed with insomnia and to explore biological and psychological mechanisms that may influence treatment effects. Additionally, the study will include health-economic analyses and collect participants' experiences with CBT-I. Participants will be randomly assigned to receive either a short, nurse-led group CBT-I program or written sleep hygiene advice. The CBT-I involves five weekly sessions, each lasting 60 to 90 minutes, delivered by specially trained cardiac nurses. This treatment follows a structured protocol including sleep hygiene guidance, stimulus control, sleep restriction, relaxation techniques, and cognitive restructuring. The comparison group will receive a 16-page brochure with general advice for better sleep. During the study, participants will be assessed for remission of insomnia at 6 to 8 weeks and again at 6 months after treatment. Researchers will measure changes in insomnia severity, sleep patterns, daytime symptoms, and quality of life. Additional biological markers such as inflammation, cortisol, and blood sugar levels will be examined. The study involves collecting daily sleep diaries before treatment and monitoring throughout the trial to evaluate outcomes and safety over the follow-up period.

Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease