Sogol Javaheri1, Michelle Reid1, Michelle Drerup2, Reena Mehra2, Susan Redline1,3. 1. Brigham and Women's Hospital, Boston and Harvard Medical School, Boston, MA. 2. Cleveland Clinic Sleep Disorders Center, Cleveland, OH. 3. Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA.
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 withwCBT-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.
RCT Entities:
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.
Authors: Hailey R Banack; Crystal D Holly; Ilka Lowensteyn; Lisa Masse; Sylvie Marchand; Steven A Grover; Deborah Da Costa Journal: J Cardiopulm Rehabil Prev Date: 2014 May-Jun Impact factor: 2.081
Authors: Nancy S Redeker; Henry Klar Yaggi; Daniel Jacoby; Christopher S Hollenbeak; Stephen Breazeale; Samantha Conley; Youri Hwang; Joanne Iennaco; Sarah Linsky; Uzoji Nwanaji-Enwerem; Meghan O'Connell; Sangchoon Jeon Journal: Sleep Date: 2022-01-11 Impact factor: 6.313