CBT-Insomnia

Cognitive behavioural therapy for insomnia in patients with coronary heart disease: A randomized controlled trial with six months follow-up

Background

There is increasing and consistent evidence of insomnia being highly prevalent (45%) in patients with coronary heart disease (CHD) and associated with significantly increased risk for major adverse cardiac events. Indeed, insomnia has been identified as the third most important risk factor for cardiac prognosis after smoking and sedentary lifestyle among CHD patients. Whereas major efforts have been made to decrease smoking and promote physical activity in accordance with international guidelines based on empirically tested effective interventions, there is a knowledge gap regarding effective treatment of insomnia in patients with CHD. Cognitive Behavioural therapy for insomnia (CBT-I) is the first line treatment for insomnia. This study will determine, for the first time, the effectiveness of CBT-I in a real world outpatient population with CHD.

Aims

The overall aim is to reduce the proportion with insomnia diagnoses and symptoms among patients with CHD. We also aim to gain new knowledge of the effect of CBT-I on quality of life, symptoms of anxiety and depression, sleep cognitions, worry and rumination, and biomarkers of inflammation, stress and glucose metabolism. Finally, we aim to provide health authorities with decision support in planning of future services for CHD patients with insomnia and explore the psychological mechanisms related to change in insomnia and the patients’ experience of CBT-I.

Method

This is a randomized, open, parallel-group intervention study designed to test the effects of CBT-I for insomnia. The CBT-I plus usual care will be used as the active treatment arm whilst usual care and information about sleep hygiene advice (SHA) will be employed as the control arm. After a 2-week baseline period involving sleep diary recording, patients who meet the study inclusion criteria will be randomized to either control arm (n=32) or treatment as usual plus five weekly sessions of cardiac nurse-led group CBT-I (n=32).

Data on sleep and health-related variables will be obtained from hospital medical records, questionnaires and sleep diaries, psychiatric and qualitative interviews, clinical examination with blood samples, hair analysis, and digital sleep and activity recorders.

Discussion

The results will provide a solid foundation for implementing improved care through improved sleep for patients with chronic insomnia and CHD.

Benefits for the patients include potentially better sleep and consequently improved daytime function, less anxiety and depression, better quality of life, lower levels of circulating biomarkers of inflammation, stress and glucose metabolism, and thus potentially fewer re-hospitalizations with subsequent CHD events and complications like heart failure, and fewer costly investigations and treatments. The results may have significant impact for healthcare providers in primary and specialist healthcare as lack of effective treatment for insomnia in CHD patients is a barrier to detect insomnia today. Although referral to a specialist is recommended in CHD patients with significant sleep problems which are not responding within 4 weeks to sleep hygiene, effective treatment is not available today. Indeed, we have recently documented that sleep problems are very rarely addressed at all at Norwegian hospitals today . CBT-I delivered in a group format by trained hospital nurses is a potentially cost-effective intervention that requires limited training and may thus be feasible for implementation in routine clinical practices. In relation to healthcare service organization and quality, we believe that formal recognition, screening, and assessment of insomnia in patients with CHD will take place more routinely if CBT is established as an acceptable, feasible and effective treatment of insomnia among this patient group. Potentially, a positive treatment outcome will be influential in motivating national and international cardiac task force groups to introduce or reinforce guidelines recommending the routine detection of insomnia disorder and CBT-I in patients with CHD across a range of clinical settings (e.g., primary and specialist healthcare), especially at cardiac rehabilitation programmes. At a more societal level, the short and long-term benefits include enhanced public awareness and understanding of the importance of the link between sleep and CHD and the availability of services to offer screening and treatment for insomnia. However, in order to establish such services in routine clinical settings, there is a need for early economic modelling for such innovative health services to be tested and optimized prior to full scale implementation. This will provide health authorities with highly desired decision support in planning of future services.

Project leader

Toril Dammen

Publications

Published Jan. 8, 2024 2:13 PM - Last modified Jan. 8, 2024 2:15 PM