Heart Failure Insomnia Treatment Study (H-FITS)

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.

Study Overview

• Status: Completed
• Conditions: Depression; Heart Failure; Sleep Disorder; Insomnia; Sleep Initiation and Maintenance Disorders; Anxiety; Congestive Heart Failure; Cardiac Failure; Disorders of Initiating and Maintaining Sleep
• Intervention / Treatment: Behavioral: Brief treatment for Insomnia; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief treatment for insomnia; 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; 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.; Other Names: BBTI
Active Comparator: Sleep Monitoring; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-intervention
Executive function	Executive function will be measured with the Trail Making Test (TMT), a paper-and-pencil neuropsychological instrument comprised of two parts, A and B. Time taken to complete each part is calculated in seconds, with longer times indicative of poorer performance. To minimize practice effects, comparable alternative forms will be used for post-intervention assessments.	Pre-intervention
Memory	Memory will be measured with the Verbal Paired Associates I and II (VPAI and VPAII) tasks, subtests included in the Wechsler Memory Scale - Fourth Edition (WMS-IV) neuropsychological battery. VPAI assesses immediate recall of verbally-presented associated word pairs and VPAII measures delayed, long-term memory. Performance is evaluated by comparing the number of correctly recalled word pairs with age-based norms, with higher scores indicative of better verbal memory.	Pre-intervention
Attention and psychomotor performance	Attention and psychomotor performance will be measured with the Coding task, a subtest included in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Participants use a key to match as many numbers to corresponding nonsense symbols as possible within a two-minute time limit. Performance is evaluated by comparing the total number of correct matches to age-based norms, with higher scores indicative of better attention and psychomotor functioning.	Pre-intervention
Decision making assessed by the IGT	Decision making will be measured with three self-administered computerized tasks. The Iowa Gambling Task (IGT) produces a score representative of risky decision making by assessing participants' tendency to choose more disadvantageous over advantageous selections. For this measure, lower scores represent greater risky decision making.	Pre-intervention
Decision making assessed by the MCQ	Decision making will be measured with three self-administered computerized tasks. The Monetary Choice Questionnaire (MCQ) is a measure of delay-discounting designed to assess preferences for smaller, more immediate rewards over larger, delayed rewards. An average score is produced based on participant responses to 27 trials, with higher values indicative of steeper discounting of delayed rewards and greater impulsivity.	Pre-intervention
Decision making assessed by the GDT	Decision making will be measured with three self-administered computerized tasks. The Game of Dice Task (GDT) produces a score representative of risky decision making by assessing participants' tendency to choose more disadvantageous over advantageous selections. For this measure, lower scores represent greater risky decision making.	Pre-intervention
Anxiety	Anxiety symptoms will be measured with the 14-item self-report Hospital Anxiety and Depression Scale (HADS). This instrument assesses symptoms of anxiety and depression specifically among patients with physical illnesses. Seven items assess symptoms of anxiety, while the remaining 7 items assess symptoms of depression. Each item is scored on a 4-point Likert-scale ranging from 0 to 3. Subscale scores, ranging from 0 to 21, can be calculated for anxiety and for depression, with higher scores indicative of greater symptoms.	Change from pre-intervention to 2 weeks post-intervention
Depression	Depressive symptoms will be measured with the 14-item self-report Hospital Anxiety and Depression Scale (HADS). This instrument assesses symptoms of anxiety and depression specifically among patients with physical illnesses. Seven items assess symptoms of anxiety, while the remaining 7 items assess symptoms of depression. Each item is scored on a 4-point Likert-scale ranging from 0 to 3. Subscale scores, ranging from 0 to 21, can be calculated for anxiety and for depression, with higher scores indicative of greater symptoms.	Change from pre-intervention to 2 weeks post-intervention
HF-related quality of life	HF-related quality of life will be measured with the 23-item self-report Kansas City Cardiomyopathy Questionnaire (KCCQ), a HF-specific measure designed to quantify physical limitations, symptoms, and HF-related quality of life. The measure includes 9 subscales that can be combined into an overall summary score ranging from 0-100, with higher scores indicative of better functioning and fewer symptoms.	Change from pre-intervention to 2 weeks post-intervention
HF self-care	HF self-care will be measured with the 15-item self-report Self Care of Heart Failure Index (SCHFI). This instrument assesses patient's adherence to specific HF dietary and symptom monitoring guidelines, their confidence in adhering to these guidelines, and the steps they take when they notice changes in their symptom status. Three subscales (Management, Maintenance, and Confidence) are scored out of 100, with higher scores representing better self-care.	Change from pre-intervention to 2 weeks post-intervention
Executive function	Executive function will be measured with the Trail Making Test (TMT), a paper-and-pencil neuropsychological instrument comprised of two parts, A and B. Time taken to complete each part is calculated in seconds, with longer times indicative of poorer performance. To minimize practice effects, comparable alternative forms will be used for post-intervention assessments.	Change from pre-intervention to 2 weeks post-intervention
Memory	Memory will be measured with the Verbal Paired Associates I and II (VPAI and VPAII) tasks, subtests included in the Wechsler Memory Scale - Fourth Edition (WMS-IV) neuropsychological battery. VPAI assesses immediate recall of verbally-presented associated word pairs and VPAII measures delayed, long-term memory. Performance is evaluated by comparing the number of correctly recalled word pairs with age-based norms, with higher scores indicative of better verbal memory.	Change from pre-intervention to 2 weeks post-intervention
Attention and psychomotor performance	Attention and psychomotor performance will be measured with the Coding task, a subtest included in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Participants use a key to match as many numbers to corresponding nonsense symbols as possible within a two-minute time limit. Performance is evaluated by comparing the total number of correct matches to age-based norms, with higher scores indicative of better attention and psychomotor functioning.	Change from pre-intervention to 2 weeks post-intervention
Decision making assessed by the MCQ	Decision making will be measured with three self-administered computerized tasks. The Monetary Choice Questionnaire (MCQ) is a measure of delay-discounting designed to assess preferences for smaller, more immediate rewards over larger, delayed rewards. An average score is produced based on participant responses to 27 trials, with higher values indicative of steeper discounting of delayed rewards and greater impulsivity.	Change from pre-intervention to 2 weeks post-intervention
Decision making assessed by the GDT	Decision making will be measured with three self-administered computerized tasks. The Game of Dice Task (GDT) produces a score representative of risky decision making by assessing participants' tendency to choose more disadvantageous over advantageous selections. For this measure, lower scores represent greater risky decision making.	Change from pre-intervention to 2 weeks post-intervention
Functional Status	Functional status will be measured with the Sixty-Foot Walk Test (60ftWT), an ambulatory measure that requires patients to walk four laps of 15 feet. Time needed to walk each of the four laps, as well as the total duration, is recorded in seconds, with higher completion times indicative of poorer functional status.	Change from pre-intervention to 2 weeks post-intervention
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 6 months 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 6 months 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 6 months post-intervention
Anxiety	Anxiety symptoms will be measured with the 14-item self-report Hospital Anxiety and Depression Scale (HADS). This instrument assesses symptoms of anxiety and depression specifically among patients with physical illnesses. Seven items assess symptoms of anxiety, while the remaining 7 items assess symptoms of depression. Each item is scored on a 4-point Likert-scale ranging from 0 to 3. Subscale scores, ranging from 0 to 21, can be calculated for anxiety and for depression, with higher scores indicative of greater symptoms.	Change from pre-intervention to 6 months post-intervention
Depression	Depressive symptoms will be measured with the 14-item self-report Hospital Anxiety and Depression Scale (HADS). This instrument assesses symptoms of anxiety and depression specifically among patients with physical illnesses. Seven items assess symptoms of anxiety, while the remaining 7 items assess symptoms of depression. Each item is scored on a 4-point Likert-scale ranging from 0 to 3. Subscale scores, ranging from 0 to 21, can be calculated for anxiety and for depression, with higher scores indicative of greater symptoms.	Change from pre-intervention to 6 months post-intervention
HF-related quality of life	HF-related quality of life will be measured with the 23-item self-report Kansas City Cardiomyopathy Questionnaire (KCCQ), a HF-specific measure designed to quantify physical limitations, symptoms, and HF-related quality of life. The measure includes 9 subscales that can be combined into an overall summary score ranging from 0-100, with higher scores indicative of better functioning and fewer symptoms.	Change from pre-intervention to 6 months post-intervention
HF self-care	HF self-care will be measured with the 15-item self-report Self Care of Heart Failure Index (SCHFI). This instrument assesses patient's adherence to specific HF dietary and symptom monitoring guidelines, their confidence in adhering to these guidelines, and the steps they take when they notice changes in their symptom status. Three subscales (Management, Maintenance, and Confidence) are scored out of 100, with higher scores representing better self-care.	Change from pre-intervention to 6 months post-intervention
Executive function	Executive function will be measured with the Trail Making Test (TMT), a paper-and-pencil neuropsychological instrument comprised of two parts, A and B. Time taken to complete each part is calculated in seconds, with longer times indicative of poorer performance. To minimize practice effects, comparable alternative forms will be used for post-intervention assessments.	Change from pre-intervention to 6 months post-intervention
Attention and psychomotor performance	Attention and psychomotor performance will be measured with the Coding task, a subtest included in the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Participants use a key to match as many numbers to corresponding nonsense symbols as possible within a two-minute time limit. Performance is evaluated by comparing the total number of correct matches to age-based norms, with higher scores indicative of better attention and psychomotor functioning.	Change from pre-intervention to 6 months post-intervention
Memory	Memory will be measured with the Verbal Paired Associates I and II (VPAI and VPAII) tasks, subtests included in the Wechsler Memory Scale - Fourth Edition (WMS-IV) neuropsychological battery. VPAI assesses immediate recall of verbally-presented associated word pairs and VPAII measures delayed, long-term memory. Performance is evaluated by comparing the number of correctly recalled word pairs with age-based norms, with higher scores indicative of better verbal memory.	Change from pre-intervention to 6 months post-intervention
Decision making assessed by the MCQ	Decision making will be measured with three self-administered computerized tasks. The Monetary Choice Questionnaire (MCQ) is a measure of delay-discounting designed to assess preferences for smaller, more immediate rewards over larger, delayed rewards. An average score is produced based on participant responses to 27 trials, with higher values indicative of steeper discounting of delayed rewards and greater impulsivity.	Change from pre-intervention to 6 months post-intervention
Decision making assessed by the GDT	Decision making will be measured with three self-administered computerized tasks. The Game of Dice Task (GDT) produces a score representative of risky decision making by assessing participants' tendency to choose more disadvantageous over advantageous selections. For this measure, lower scores represent greater risky decision making.	Change from pre-intervention to 6 months post-intervention
Functional Status	Functional status will be measured with the Sixty-Foot Walk Test (60ftWT), an ambulatory measure that requires patients to walk four laps of 15 feet. Time needed to walk each of the four laps, as well as the total duration, is recorded in seconds, with higher completion times indicative of poorer functional status.	Change from pre-intervention to 6 months post-intervention

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Charles Emery, Ph.D., Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: memory; quality of life; depression; insomnia; anxiety; heart failure; functional status; decision making; attention; self-care; executive functioning; walk test; sleep monitoring
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Heart Failure; Depression; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2016H0451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No