Insomnia Self-Management in Heart Failure

Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and
high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients
report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the
morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may
contribute to the development and exacerbation of HF and incident mortality. It is also
associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression,
excessive daytime sleepiness, and pain) and decrements in objective and subjective functional
performance.However, insomnia is under-diagnosed and under-treated in this population.

Cognitive behavioral therapy for insomnia (CBT-I) is a multi-modal behavioral treatment
focused on modifying beliefs and attitudes about sleep and is efficacious in many
populations. The purposes of RCT are to evaluate the sustained effects of CBT-I, compared
with HF self-management education (attention control), on insomnia severity, sleep
characteristics, daytime symptoms, and functional performance over twelve months among
patients who have stable chronic HF and chronic insomnia and receive evidence-based HF
disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the
attention-control condition and explore the effects of CBT-I on event-free survival. We will
address the following specific aims (*primary outcomes): (1) Test the sustained effects
(baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks,
compared with HF self-management education (attention control condition), on: (1a) *insomnia
severity and self-reported and actigraph-recorded sleep characteristics (*sleep quality,
*sleep efficiency, sleep latency, and duration); (1b) symptoms (*fatigue, anxiety,
depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and
(1c) symptom clusters [membership in clusters characterized by severity of specific symptoms;
transition between clusters over time]; (2) Test the sustained effects of CBT-I on
self-reported and objective functional performance; and (3) Examine the cost-effectiveness of
CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival.

A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an
attention control condition consisting of HF self-management education. Wrist actigraph
measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and
self-report measures of insomnia, sleep, symptoms, and functional performance will be
obtained at baseline and follow-up. Data analysis will consist of mixed effects models,
latent transition analysis, stochastic cost-effectiveness analysis, and survival analysis.

Inclusion Criteria:

- stable chronic heart failure, chronic insomnia, English speaking/reading,

Exclusion Criteria:

- untreated sleep disordered breathing or restless legs syndrome, rotating/night shift
work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting
the non-dominant arm end-stage renal failure, significant cognitive impairment,
unstable medical or psychiatric disorders