Cognitive Behavioral Therapy for Insomnia in Heart Disease Patients

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

This study tests whether Cognitive Behavioral Therapy for Insomnia can help people with heart disease sleep better and improve their heart health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Vestre Viken Hospital Trust (other)
• Locations: 1 site (Drammen, Buskerud)
• Trial ID: NCT06749951 on ClinicalTrials.gov

What this trial studies

This project investigates the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) in patients with coronary heart disease (CHD), who often experience insomnia. The study will involve a randomized intervention with 66 outpatient participants diagnosed with insomnia, aiming to document the therapy's impact on sleep quality and cardiovascular health. Additionally, it will explore the biological and psychological mechanisms behind the therapy's effects and include a health-economic simulation and qualitative assessments of participant experiences.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of coronary heart disease and insomnia.

Not a fit: Patients with moderate to severe cognitive impairment or other significant health risks may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve sleep quality and reduce cardiovascular risks in patients with coronary heart disease.

How similar studies have performed: While CBT-I is a well-established treatment for insomnia, studies specifically targeting CHD patients are limited, making this approach relatively novel.

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

Where this trial is running

Drammen, Buskerud

• Vestre Viken Trust Drammen hospital — Drammen, Buskerud, Norway (RECRUITING)

Study contacts

• Study coordinator: John D Munkhaugen, MD, PhD

Conditions: Insomnia Chronic, Coronary Heart Disease