Clinical trial NCT03636880: Heart Failure Insomnia Treatment Study
Official title: Insomnia, Cognitive Impairment, and Decision Making Among Patients With Heart Failure:A Randomized Study of Brief Behavioral Treatment for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Cardiac Failure
Congestive Heart Failure
Insomnia
Sleep Disorder
Sleep Initiation and Maintenance Disorders
Disorders of Initiating and Maintaining Sleep
Anxiety
Depression
Keywords: heart failure
insomnia
anxiety
depression
memory
attention
executive functioning
decision making
self-care
quality of life
functional status
walk test
sleep monitoring
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia severity
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Sleep quality assessed by the PSQI
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Sleep efficiency
timeFrame: Change from pre-intervention to 2 weeks post-intervention
Secondary outcomes:
measure: Insomnia severity
timeFrame: Pre-intervention
measure: Executive function
timeFrame: Pre-intervention
measure: Memory
timeFrame: Pre-intervention
measure: Attention and psychomotor performance
timeFrame: Pre-intervention
measure: Decision making assessed by the IGT
timeFrame: Pre-intervention
measure: Decision making assessed by the MCQ
timeFrame: Pre-intervention
measure: Decision making assessed by the GDT
timeFrame: Pre-intervention
measure: Anxiety
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Depression
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: HF-related quality of life
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: HF self-care
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Executive function
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Memory
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Attention and psychomotor performance
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Decision making assessed by the MCQ
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Decision making assessed by the GDT
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Functional Status
timeFrame: Change from pre-intervention to 2 weeks post-intervention
measure: Insomnia severity
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Sleep quality assessed by the PSQI
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Sleep efficiency
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Anxiety
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Depression
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: HF-related quality of life
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: HF self-care
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Executive function
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Attention and psychomotor performance
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Memory
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Decision making assessed by the MCQ
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Decision making assessed by the GDT
timeFrame: Change from pre-intervention to 6 months post-intervention
measure: Functional Status
timeFrame: Change from pre-intervention to 6 months post-intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Charles Emery, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: