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Heart Failure Insomnia Treatment Study (H-FITS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03636880
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Charles Emery PhD, Ohio State University

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.


Condition or disease Intervention/treatment Phase
Heart Failure Cardiac Failure Congestive Heart Failure Insomnia Sleep Disorder Sleep Initiation and Maintenance Disorders Disorders of Initiating and Maintaining Sleep Anxiety Depression Behavioral: Brief treatment for Insomnia Behavioral: Sleep Monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Insomnia, Cognitive Impairment, and Decision Making Among Patients With Heart Failure:A Randomized Study of Brief Behavioral Treatment for Insomnia
Actual Study Start Date : February 24, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: 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.




Primary Outcome Measures :
  1. Insomnia severity [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  2. Sleep quality assessed by the PSQI [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  3. Sleep efficiency [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.


Secondary Outcome Measures :
  1. Insomnia severity [ Time Frame: Pre-intervention ]
    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.

  2. Executive function [ Time Frame: Pre-intervention ]
    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.

  3. Memory [ Time Frame: Pre-intervention ]
    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.

  4. Attention and psychomotor performance [ Time Frame: Pre-intervention ]
    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.

  5. Decision making assessed by the IGT [ Time Frame: Pre-intervention ]
    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.

  6. Decision making assessed by the MCQ [ Time Frame: Pre-intervention ]
    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.

  7. Decision making assessed by the GDT [ Time Frame: Pre-intervention ]
    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.

  8. Anxiety [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  9. Depression [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  10. HF-related quality of life [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  11. HF self-care [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  12. Executive function [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  13. Memory [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  14. Attention and psychomotor performance [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  15. Decision making assessed by the MCQ [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  16. Decision making assessed by the GDT [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  17. Functional Status [ Time Frame: Change from pre-intervention to 2 weeks post-intervention ]
    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.

  18. Insomnia severity [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  19. Sleep quality assessed by the PSQI [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  20. Sleep efficiency [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  21. Anxiety [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  22. Depression [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  23. HF-related quality of life [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  24. HF self-care [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  25. Executive function [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  26. Attention and psychomotor performance [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  27. Memory [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  28. Decision making assessed by the MCQ [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  29. Decision making assessed by the GDT [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.

  30. Functional Status [ Time Frame: Change from pre-intervention to 6 months post-intervention ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636880


Contacts
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Contact: Steven Schiele, M.A. 614-688-3895 schiele.6@osu.edu
Contact: Kristie Harris, Ph.D. 614-688-3895 harris.1815@osu.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Steven Schiele, M.A.    614-688-3895    schiele.6@osu.edu   
Contact: Kristie Harris, Ph.D.    614-688-3895    harris.1815@osu.edu   
Principal Investigator: Charles Emery, Ph.D.         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Charles Emery, Ph.D. Ohio State University

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Responsible Party: Charles Emery PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03636880     History of Changes
Other Study ID Numbers: 2016H0451
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Charles Emery PhD, Ohio State University:
heart failure
insomnia
anxiety
depression
memory
attention
executive functioning
decision making
self-care
quality of life
functional status
walk test
sleep monitoring
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Heart Failure
Disease
Depression
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms