Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial.
Chronic insomnia is associated with disabling symptoms and decrements in functional performance. It may contribute to the development of heart failure (HF) and incident mortality. In our previous work, cognitive-behavioral therapy for insomnia (CBT-I), compared to HF self-management education, provided as an attention control condition, was feasible, acceptable, and had large effects on insomnia and fatigue among HF patients.



The purpose of this randomized controlled trial (RCT) is to evaluate the sustained effects of group CBT-I compared with HF self-management education (attention control) on insomnia severity, sleep characteristics, daytime symptoms, symptom clusters, functional performance, and health care utilization among patients with stable HF. We will estimate the cost-effectiveness of CBT-I and explore the effects of CBT-I on event-free survival (EFS).



Two hundred participants will be randomized in clusters to a single center parallel group (CBT-I vs. attention control) RCT. Wrist actigraphy and self-report will elicit insomnia, sleep characteristics, symptoms, and functional performance. We will use the psychomotor vigilance test to evaluate sleep loss effects and the Six Minute Walk Test to evaluate effects on daytime function. Medical record review and interviews will elicit health care utilization and EFS. Statistical methods will include general linear mixed models and latent transition analysis. Stochastic cost-effectiveness analysis with a competing risk approach will be employed to conduct the cost-effectiveness analysis.



The results will be generalizable to HF patients with chronic comorbid insomnia and pave the way for future research focused on the dissemination and translation of CBT-I into HF settings.
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: nancy.redeker@yale.edu.
Nancy S
NS
Redeker
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: andrea.knies@yale.edu.
Andrea K
AK
Knies
Penn State Milton S. Hershey Medical Center, 500 University Drive, Hershey, PA 17033, United States. Electronic address: csh10@psu.edu.
Christopher
C
Hollenbeak
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States; Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, United States. Electronic address: henry.yaggi@yale.edu.
H
H
Klar Yaggi
Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, United States. Electronic address: jcclineusa@yahoo.com.
John
J
Cline
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: laura.andrews@yale.edu.
Laura
L
Andrews
Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, United States. Electronic address: Daniel.jacoby@yale.edu.
Daniel
D
Jacoby
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: a.sullivan@yale.edu.
Anna
A
Sullivan
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: Meghan.oconnel@yale.edu.
Meghan
M
O'Connell
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: joanne.iennaco@yale.edu.
Joanne
J
Iennaco
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: lisa.finoia@yale.edu.
Lisa
L
Finoia
Yale School of Nursing, 400 West Campus Drive, West Haven, CT 06477, United States. Electronic address: sangchoon.jeon@yale.edu.
Sangchoon
S
Jeon
D056044:Actigraphy; D002908:Chronic Disease; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003362:Cost-Benefit Analysis; D006333:Heart Failure / Q000453:epidemiology*; D006801:Humans; D012107:Research Design; D000073278:Self-Management; D007319:Sleep Initiation and Maintenance Disorders / Q000453:epidemiology* / Q000628:therapy*
Cognitive behavioral therapy; Heart failure; Insomnia; Self-management; Sleep; Symptoms