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Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial
Nancy S Redeker1, Andrea K Knies1, Christopher Hollenbeak2
1Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States.
Cognitive-behavioral therapy for insomnia (CBT-I) significantly improves sleep and daytime function in heart failure (HF) patients. This study assesses the long-term effectiveness and cost-effectiveness of CBT-I for managing insomnia in HF.
Area of Science:
- Cardiology
- Sleep Medicine
- Behavioral Science
Background:
- Chronic insomnia is linked to poor health outcomes, including heart failure (HF) and mortality.
- Previous research indicated cognitive-behavioral therapy for insomnia (CBT-I) is effective for insomnia and fatigue in HF patients.
Purpose of the Study:
- To evaluate sustained effects of group CBT-I versus HF self-management education on insomnia, sleep, daytime symptoms, function, and healthcare use in stable HF patients.
- To estimate the cost-effectiveness of CBT-I and explore its impact on event-free survival (EFS).
Main Methods:
- A randomized controlled trial (RCT) involving 200 participants in a single center, cluster-randomized design.
- Utilized wrist actigraphy, self-report, psychomotor vigilance test, and the Six Minute Walk Test for data collection.
- Employed general linear mixed models, latent transition analysis, and stochastic cost-effectiveness analysis with competing risks.
Main Results:
- Results are pending, but the study is designed to assess sustained improvements in insomnia, sleep, and functional performance.
- The cost-effectiveness and impact on event-free survival will be determined.
Conclusions:
- Findings are expected to support the integration of CBT-I into heart failure care settings.
- This research aims to facilitate the dissemination and translation of CBT-I for HF patients with comorbid insomnia.
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