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.

Trial registration: ClinicalTrials.gov NCT02660385.

Keywords: Cognitive behavioral therapy; Heart failure; Insomnia; Self-management; Sleep; Symptoms.

Conflict of interest statement

Competing interests

The authors have no competing interests to declare.

Copyright © 2017 Elsevier Inc. All rights reserved.

Figures

Figure 1. Organizing Framework

Solid-lined boxes/arrow = outcomes; double lined box/arrow = intervention; broken boxes/arrows = factors likely to contribute to insomnia, healthcare resource utilization, symptoms, functional performance, and event -free survival (possible covariates); LVEF = Left ventricular ejection fraction; C-PAP = Continuous positive airway pressure

Figure 2. Participant flow diagram

ISI = Insomnia Severity Index [32]; AHI = Apnea-Hypopnea Index; C-PAP = Continuous positive airway pressure; RLS = Restless legs syndrome; ESS = Epworth Sleepiness Scale [38]; HF = Heart failure