Clinical trial NCT06749951: Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
Official title: Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease: A Randomized Controlled Trial With Six Months Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Coronary Heart Disease
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of Oslo
First posted: 2024-12-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria (all the following):

* 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

Exclusion criteria (any of the following):

* Any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to:
* 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
* Not being able to understand Norwegian.
* No other significant sleep disorder, as assessed via the Structured Clinical Interview for Sleep disorders (Kallestad et al., 2022)
* A clinical diagnosis of Obstructive Sleep Apnea (OSA) (not treated with CPAP) recorded in the hospital medical records, under evaluation for OSA, and/or a score ≥5 on the STOP-Bang OSA screening questionnaire

Primary outcomes:
measure: Remission clinical diagnosis of insomnia
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in insomnia severity
timeFrame: From baseline to weeks 6-8 and 26
Secondary outcomes:
measure: Changes in insomnia assessed by the Pittsburgh Sleep Quality Index
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in subjective sleep efficiency
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in objective sleep efficiency
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in subjective total sleep time
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in objective total sleep time
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in subjective sleep onset latency
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in objective sleep onset latency
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in subjective wake after sleep onset
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in objective wake after sleep onset
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in symptoms of depression and anxiety
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in daytime sleepiness
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in fatigue
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in general quality of life
timeFrame: From baseline to weeks 6-8 and 26
measure: Changes in sleep-related quality of life
timeFrame: From baseline to weeks 6-8 and 26
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken Trust Drammen hospital
state: Buskerud
Study officials:
References: