Actively Recruiting
Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease: A Randomized Controlled Trial With Six Months Follow-up
Led by Vestre Viken Hospital Trust · Updated on 2025-01-09
76
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vestre Viken Hospital Trust
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Insomnia is common in patients with coronary heart disease (CHD), affecting about 45% of this group and increasing the risk of further heart problems. This research aims to evaluate the effectiveness of Cognitive Behavioural Therapy for Insomnia (CBT-I) in helping CHD outpatients who have insomnia, compared to sleep hygiene advice. The study also seeks to understand the biological and psychological factors that may influence treatment effects and to explore participants' experiences and health-economic outcomes. Participants will be randomly assigned to one of two groups: one receiving a short, nurse-led CBT-I program delivered in group sessions over five weekly meetings, and the other receiving written sleep hygiene advice. The CBT-I includes techniques such as sleep hygiene, stimulus control, sleep restriction, relaxation training, and cognitive restructuring. The study will follow participants for six months after treatment to assess outcomes. Throughout the study, participants will complete sleep diaries and undergo assessments of insomnia severity using the Bergen Insomnia Scale and other measures like the Pittsburgh Sleep Quality Index, sleep efficiency, total sleep time, and symptoms of depression or anxiety. The researchers will also collect data on inflammation, cortisol, and blood sugar levels. The main outcomes include remission of insomnia and changes in insomnia severity at the end of treatment and six months later, with ongoing monitoring to evaluate quality of life and daytime symptoms.
CONDITIONS
Brief Title
Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years and able to cooperate and provide informed consent according to regulations
- Hospitalized with acute myocardial infarction and/or angiography-confirmed coronary atherosclerosis, or had a coronary revascularization procedure at Drammen Hospital between 2021 and 2024
- Positive score for insomnia measured with the Bergen Insomnia Score
- Completed at least 10 out of 14 daily sleep diaries during pre-randomization assessment
You will not qualify if you...
- Conditions that may pose significant risk, affect study results, or interfere with participation, including moderate or severe cognitive impairment, seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive or bipolar disorders, concurrent psychological treatments, or ongoing night shift work
- Neurological or musculoskeletal disorders limiting movement of the dominant arm affecting wrist actigraphy
- Diagnosis of heart failure or elevated NT-proBNP (>125 pg/mL)
- Life expectancy under 12 months due to end-organ or malignant diseases
- Inability to understand Norwegian
- Other significant sleep disorders or untreated obstructive sleep apnea (OSA), or high risk of OSA based on screening questionnaire
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive either Cognitive Behavioural Therapy for insomnia (CBT-I) consisting of five 60-90 minute weekly sessions delivered by a trained cardiac nurse, or Sleep Hygiene Advice through a written brochure.
Weekly visits for 5 weeks
Duration - Up to 6 months
Participants are followed up to assess changes in insomnia severity, sleep quality, depression and anxiety symptoms, fatigue, and quality of life up to six months after treatment.
Visits at approximately weeks 6-8 and at 6 months
Trial Site Locations
Total: 1 location
1
Vestre Viken Trust Drammen hospital
Drammen, Buskerud, Norway, 3014
Actively Recruiting
Research Team
J
John D Munkhaugen, MD, PhD
T
Toril Dammen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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