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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Norway
Vestre Viken Trust Drammen hospital
RECRUITING
Drammen
Contact Information
Primary
John D Munkhaugen, MD, PhD
johmun@vestreviken.no
+4797524194
Backup
Toril Dammen, MD, PhD
toril.dammen@medisin.uio.no
+4790163433
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2026-06-15
Participants
Target number of participants: 76
Treatments
Experimental: Cognitive Behavioural Therapy for insomnia (CBT-I)
Active_comparator: Sleep Hygiene Advice
Related Therapeutic Areas
Sponsors
Collaborators: University of Oslo, Oslo University Hospital
Leads: Vestre Viken Hospital Trust

This content was sourced from clinicaltrials.gov