Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial

Abstract

Background 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. Objectives 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). Methods 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. Discussion 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.

Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure

“…We also provided payments to participants that were proportional to the research requirements, but it possible that payments may contribute to perceptions about sleep or treatment. We are now conducting an NIH-funded study (Redeker et al, 2017) with a larger, full powered sample and longer term follow-up over a full year that will enable further evaluation of the effects found in this study and more fine-grained evaluation of the potential cognitive and behavioral mechanisms that may explain longterm effects of CBT-I among patients with HF.…”

Retracted: A randomized controlled trial of mindfulness‐based stress reduction for insomnia secondary to cervical cancer: Effects on sleep

“…This corresponds with previous studies utilizing actigraphy. [31][32][33] Demographic and clinical history data were collected at baseline.…”

Potential effectiveness of sleep hygiene and relaxation Benson in improving the quality of sleep in patients with heart failure: Literature review

“…The mechanisms underlying sleep disorders or insomnia in patients with heart failure are caused by nocturnal symptoms that cause sleep disorders, such as coughing, orthopnea, paroxysmal nocturnal dyspnea, and nocturia (15). In addition, the results of the study show that there are behavioral factors that cause sleep disturbances in heart failure patients that are associated with increased bedtime even though they are still awake (16,17), perception of insufficient sleep, frequent naps (17,18), and television use that can help them sleep (19,20).…”