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<h5 class="section-title" id="d11878755e212">Background</h5>
<p id="P2">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.
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<h5 class="section-title" id="d11878755e217">Objectives</h5>
<p id="P3">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).
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<h5 class="section-title" id="d11878755e222">Methods</h5>
<p id="P4">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.
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<h5 class="section-title" id="d11878755e227">Discussion</h5>
<p id="P5">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.
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