Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease

Launched by VESTRE VIKEN HOSPITAL TRUST · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective Cognitive Behavioural Therapy for Insomnia (CBT-I) is for patients with coronary heart disease (CHD) who also suffer from insomnia. Insomnia is a common problem for these patients, affecting nearly half of them, and it can lead to more serious heart issues. The trial aims to see if CBT-I, which is a type of therapy designed to help people sleep better, can improve sleep and overall health in these patients. Participants will be randomly assigned to either receive CBT-I in a group setting or get sleep advice, and the researchers will track their sleep improvements and health outcomes over time.

To be eligible for the trial, participants must be aged between 18 and 75, have been hospitalized for heart-related issues like a heart attack, and have a confirmed diagnosis of insomnia. They should also be able to understand Norwegian and be willing to complete sleep diaries. Throughout the study, participants can expect to share their experiences with the therapy, and researchers will also look at how this treatment affects their overall health, including factors like inflammation and stress levels. This trial is important because it could provide valuable insights into how treating insomnia might help improve heart health in a large group of patients.

Gender

ALL

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