Cognitive Behavioural Therapy for Insomnia in Patients With Coronary Heart Disease
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
| Condition(s) | Insomnia Chronic, Coronary Heart Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 experien |
| Who can participate | 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 li |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Vestre Viken Hospital Trust |
| Locations | Drammen, Buskerud, Norway |
| Start date | 2024-12-30 |
| NCT ID | NCT06749951 |
| Official listing | https://clinicaltrials.gov/study/NCT06749951 |