Trial Purpose and Description
The purposes of this two group randomized controlled trial (RCT) are to test the sustained effects of cognitive behavioral therapy for insomnia (CBT-I), compared with heart failure (HF) self-management education (attention control) on insomnia severity, objective an subjective sleep characteristics, daytime symptoms, functional performance, and health care utilization over twelve months among patients who have stable HF and chronic comorbid insomnia. We will also 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, dyspnea, 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.
Hypotheses: CBT-I, compared with an attention-control condition (HF self-management education), leads to: (1a) decreased insomnia severity and sleep latency and increased sleep quality, duration and efficiency that are sustained at 6, 9 and 12 months; (1b) decreases in severity of symptoms and improvements in psychomotor vigilance that are sustained at 6, 9 and 12 months; and 1c) transition between symptom clusters that have higher symptom severity to those that have lower symptom severity over time. (2) CBT-I will lead to increased self-reported and objective functional performance; (3) CBT-I is cost-effective, compared with HF self-management education alone.
Ages: 18 years and younger
- stable chronic heart failure, chronic insomnia, English speaking/reading,
- 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
National Institutes of Health
Start Date: 06/25/2009
End Date: 06/30/2019
Last Updated: 02/22/2018
Study HIC#: 0904005041