Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVestre Viken Hospital Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75 years and signed informed consent and expected cooperation according to ICH/GCP and national/local regulations
Hospitalised with acute myocardial infarction and/or angiography-verified coronary atherosclerosis, or a coronary revascularisation procedure at Drammen Hospital 2021-2024
A positive score for insomnia measured with Bergen Insomnia Score
At least 10 of 14 daily diaries completed of the sleep diary during pre-randomization assessment
Disqualifiers
Moderate or severe cognitive impairment (i.e. recorded in hospital records or a Montreal Cognitive Assessment brief version score < 11), seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work.
Neurological or musculoskeletal disorders that restrict movement of the dominant arm because of the possible confounding effects on wrist actigraphy recordings.
A diagnosis of heart failure recorded in the hospital medical records and/or an NT-proBNP >125 pg/mL
Short life expectancy (<12 months) due to end-organ (i.e COPD 4, CKD 4/5) or malignant diseases
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioural Therapy for insomnia (CBT-I)
Other interventionFive 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 Hygiene Advice
Other intervention"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).
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioural Therapy for insomnia (CBT-I)Experimental treatment 1 intervention
Group B: Sleep Hygiene AdviceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 262
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 26Secondary outcomes
1
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 262
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 263
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 264
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 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vestre Viken Hospital Trust
Lead sponsor
Oslo University Hospital
Collaborator
University of Oslo
Collaborator
Source ClinicalTrials.gov