Heart Failure Insomnia Treatment Study (H-FITS)

The Ohio State University

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders; Cardiac Failure; Sleep Disorder; Insomnia; Depression; Heart Failure; Anxiety; Disorders of Initiating and Maintaining Sleep; Congestive Heart Failure

Treatments: Behavioral: Sleep Monitoring; Behavioral: Brief treatment for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT03636880

2016H0451

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Brief treatment for insomnia

Experimental group

Description:

Brief Behavioral Treatment for Insomnia (BBTI) is a manualized, individual intervention designed to modify sleep patterns to reduce insomnia and improve sleep quality and efficiency. Participants complete two in-person meetings and two booster telephone calls over a four-week period.

Treatment:

Behavioral: Brief treatment for Insomnia

Sleep Monitoring

Active Comparator group

Description:

Sleep Monitoring is an active comparator condition where participants track their sleep patterns for two weeks prior to the baseline and post-intervention assessments. They receive no contact from study staff during the intervening four-week period, except for a reminder call to begin completing the second sleep diary and to schedule the post-intervention assessment.

Treatment:

Behavioral: Sleep Monitoring