Reducing Coronary Heart Disease Risk Through Treatment of Insomnia Using Web-Based Cognitive Behavioral Therapy for Insomnia: A Methodological Approach

ABSTRACT

Objective: Observational data demonstrate increased risk of recurrent acute coronary syndrome in patients with comorbid insomnia. We conducted a pragmatic randomized controlled pilot study to address knowledge gaps and inform future large-scale randomized trials to test the impact of Web-based cognitive behavioral therapy for insomnia (wCBT-I) on coronary heart disease (CHD) outcomes. Participants: Thirty-five adults recruited from Brigham and Women’s and Cleveland Clinic Hospitals with insomnia, defined by Insomnia Severity Index (ISI) score ≥ 10 and symptoms of at least 3 months, and comorbid CHD identified from medical records. Methods: We randomized 34 patients to either general sleep education coupled with wCBT-I or general sleep education alone followed by an opportunity for treatment after the study (a wait-list control) to evaluate feasibility and uptake of insomnia treatment in patients with heart disease. Participants completed the ISI at baseline and 6 weeks to assess insomnia severity. Results: Twenty-nine adults completed the trial, yielding an 85% retention rate, and adherence rate in the treatment arm was 80%. Mean age was 71.6 ± 9.5 years, 75% were male, and mean body mass index (BMI) was 29 ± 4.5 kg/m². Baseline ISI scores were 15.6. There was a 6.2 ± 5.3 point reduction in ISI scores in the intervention arm and a 3.3 ± 5.1 reduction in the control arm (p value 0.1). Conclusion: Web-based CBT-I intervention was feasible in an older sample with prevalent CHD and resulted in clinically meaningful improvement in insomnia severity, though statistical significance was limited by lack of power.

Acknowledgments

We would like to acknowledge the assistance of our research assistants, Bea Oropeza, Joan Aylor, and Rawan Nawabit, our data manager, Mike Rueschman, and the participation of our patients.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

The National Heart, Lung, and Blood Institute (NHLBI) has provided individual funding under the grant number 5T32HL007901.