Heart Failure Insomnia Treatment Study



Status:Recruiting
Conditions:Anxiety, Anxiety, Depression, Insomnia Sleep Studies, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:8/19/2018
Start Date:February 24, 2017
End Date:December 2019
Contact:Kristie Harris, Ph.D.
Email:harris.1815@osu.edu
Phone:614-688-3895

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Insomnia, Cognitive Impairment, and Decision Making Among Patients With Heart Failure:A Randomized Study of Brief Behavioral Treatment for Insomnia

The purpose of this study is to compare a short, behavioral treatment for insomnia with sleep
monitoring to determine whether these approaches are effective in reducing insomnia and
improving sleep quality among patients with heart failure (HF). This study will also examine
the relationship between insomnia and cognitive functioning in HF and the effects of the
behavioral treatment on cognitive functioning, self-care, distress, HF symptoms, and
functional status.

Participants will be randomly assigned to four-sessions of a behavioral treatment (Brief
Behavioral Treatment for Insomnia; BBTI) or sleep monitoring.

Comorbid insomnia is prevalent among heart failure (HF) patients and associated with poorer
mental and physical functioning, including possible exacerbation of cognitive deficits.
Initial investigations document the effectiveness of cognitive-behavioral therapy for the
treatment of insomnia in HF. However, the high symptom burden of HF necessitates alternative
interventions for these patients with fewer time and physical endurance demands.

Brief Behavioral Treatment for Insomnia (BBTI) is a four-session behavioral intervention that
emphasizes stimulus control and sleep restriction techniques, along with providing education
to patients about healthy sleep practices and behaviors that adversely affect sleep. The
efficacy of BBTI has been previously documented in samples of older adults with insomnia, but
the intervention has yet to be applied to a disease-specific patient population.

This study was designed to 1) evaluate the treatment effects of BBTI on insomnia among HF
patients, 2) examine the relationship between insomnia, cognitive function, and
decision-making in HF patients at baseline, and 3) evaluate the effects of BBTI on relevant
correlates of insomnia in HF patients, including cognitive functioning, decision-making,
distress, self-care, quality of life, and functional status.

Participants will be randomized to either the four-session behavioral intervention (BBTI) or
a sleep monitoring condition. Measures of sleep (insomnia, sleep efficiency, sleep quality),
cognitive functioning (memory, attention, executive functioning, and decision making),
distress (anxiety and depression), HF-related quality of life, HF self-care, and functional
status will be obtained from participants at baseline, post-intervention, and 6 months
post-intervention. Repeated measures multivariate analysis of variance (MANOVA) will serve as
the primary mode of data analysis.

Inclusion Criteria:

- 18 years of age or older

- Fluent in English

- Diagnosis of heart failure

- At least mild chronic insomnia

Exclusion Criteria:

- Restless legs syndrome

- Narcolepsy

- Perform night or rotating shift work

- Seizure disorder

- Excessive daytime sleepiness

- Current or past diagnosis of Bipolar disorder or psychotic disorder

- Significant cognitive impairments

- Untreated moderate to severe sleep apnea or high risk for sleep apnea
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Charles Emery, Ph.D.
Phone: 614-688-3895
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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from
Columbus, OH
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