Heart Failure Insomnia Treatment Study

NCT03636880 | Completed

• 1 other identifier: 2016H0451
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Insomnia severity

  Insomnia symptoms will be measured with the 7-item self-report Insomnia Severity Index (ISI). This measure assesses the severity of sleep-onset and sleep maintenance difficulties, sleep satisfaction, as well as associated daytime dysfunction and distress over the prior two weeks. Items are answered on a 5-point Likert-scale from 0 'not at all' to 4 'extremely'. Total scores range from 0 to 28, with higher scores reflective of greater insomnia severity. Scores of 8 or greater indicate the presence of at least mild clinical insomnia.

  Change from pre-intervention to 2 weeks post-intervention

• Sleep quality assessed by the PSQI

  Sleep quality will be measured with the 19-item self-report Pittsburgh Sleep Quality Index (PSQI). Seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction) are derived from the instrument which can then be summed to produce a total 'global' PSQI score ranging from 0 to 21. Total PSQI scores greater than 5 indicate poor sleep quality.

  Change from pre-intervention to 2 weeks post-intervention

• Sleep efficiency

  Sleep efficiency (SE) will be measured with two-week sleep diaries where participants log their daily bed and wake times, as well as the number of hours of sleep each night. SE will be calculated as the percentage of sleep time divided by time spent in bed, with higher percentages indicative of more efficient sleep.

  Change from pre-intervention to 2 weeks post-intervention

Secondary Outcomes (30)

• Insomnia severity

  Pre-intervention

• Executive function

  Pre-intervention

• Memory

  Pre-intervention

• Attention and psychomotor performance

  Pre-intervention

• Decision making assessed by the IGT

  Pre-intervention

Study Arms (2)

Brief treatment for insomnia

EXPERIMENTAL

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.

Behavioral: Brief treatment for Insomnia

Sleep Monitoring

ACTIVE COMPARATOR

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.

Behavioral: Sleep Monitoring

Interventions

Brief treatment for Insomnia BEHAVIORAL

This behavioral intervention provides participants with an individualized plan to modify sleep patterns contributing to insomnia, as well as education about sleep hygiene and habits that help and hurt sleep.

Also known as: BBTI

Brief treatment for insomnia

Sleep Monitoring BEHAVIORAL

This intervention involves using sleep diaries to track daily aspects of sleep, including bed time, wake time, hours of sleep, nighttime awakenings, daytime naps, and sleep quality.

Sleep Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Fluent in English
• Diagnosis of heart failure
• At least mild chronic insomnia

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart Failure; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Anxiety Disorders; Depression

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Charles Emery, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Baseline assessment is completed prior to randomization. Assessments conducted at 2 weeks and 6 months post-intervention are completed by an assessor blinded to participants' assigned condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 17, 2018
• Study Start: February 24, 2017
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)