Heart FailureH-FITSNCT03636880
Heart Failure Insomnia Treatment Study
A study testing Brief treatment for Insomnia and Sleep Monitoring in people with Heart Failure and Cardiac Failure, run by Ohio State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Failure, Congestive Heart Failure
- What is being tested?
- Brief treatment for Insomnia and Sleep Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2017to 29 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Fluent in English
- Diagnosis of heart failure
- At least mild chronic insomnia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Insomnia, Sleep Disorder, Sleep Initiation and Maintenance Disorders
- Being tested
- Brief treatment for Insomnia, Sleep Monitoring
- Keywords
- heart failure, insomnia, anxiety, depression, memory, attention, executive functioning, decision making, self-care, quality of life, functional status, walk test, sleep monitoring
- Medical subject headings
- Heart Failure, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief treatment for InsomniaBehavioural
Also called BBTI
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.
Sleep MonitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sleep Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from pre-intervention to 2 weeks post-intervention
Secondary outcomes (30)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from pre-intervention to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start24 Feb 2017
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Emery PhD, Ohio State University
- Investigators
- Charles Emery, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636880
- Sponsor's protocol ID
- 2016H0451
- Acronym
- H-FITS
- Status last verified
- Apr 2024
- First submitted
- 8 Aug 2018
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insomnia, Cognitive Impairment, and Decision Making Among Patients With Heart Failure:A Randomized Study of Brief Behavioral Treatment for Insomnia
- ClinicalTrials.gov ID
- NCT03636880
- Acronym / sponsor ID
- H-FITS / 2016H0451
- Conditions
- Heart Failure, Cardiac Failure, Congestive Heart Failure, Insomnia, Sleep Disorder, Sleep Initiation and Maintenance Disorders
- Keywords
- heart failure, insomnia, anxiety, depression, memory, attention, executive functioning, decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief treatment for insomnia | Experimental | Behavioral: Brief treatment for InsomniaBrief 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. |
| Sleep Monitoring | Active comparator | Behavioral: Sleep MonitoringSleep 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Fluent in English
- Diagnosis of heart failure
- At least mild chronic insomnia
Key exclusion criteria (8 listed)
- Restless legs syndrome
- Narcolepsy
- Perform night or rotating shift work
- Seizure disorder
- Excessive daytime sleepiness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief treatment for InsomniaAlso: BBTIThis 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. | Behavioural | Brief treatment for insomnia |
| Sleep MonitoringThis 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. | Behavioural | Sleep Monitoring |
Primary outcome
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.
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.
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.
30 secondary outcomes
Insomnia severity
Time frame: Pre-intervention
Executive function
Time frame: Pre-intervention
Memory
Time frame: Pre-intervention
Attention and psychomotor performance
Time frame: Pre-intervention
Decision making assessed by the IGT
Time frame: Pre-intervention
Decision making assessed by the MCQ
Time frame: Pre-intervention
Decision making assessed by the GDT
Time frame: Pre-intervention
Anxiety
Time frame: Change from pre-intervention to 2 weeks post-intervention
Depression
Time frame: Change from pre-intervention to 2 weeks post-intervention
HF-related quality of life
Time frame: Change from pre-intervention to 2 weeks post-intervention
HF self-care
Time frame: Change from pre-intervention to 2 weeks post-intervention
Executive function
Time frame: Change from pre-intervention to 2 weeks post-intervention
Memory
Time frame: Change from pre-intervention to 2 weeks post-intervention
Attention and psychomotor performance
Time frame: Change from pre-intervention to 2 weeks post-intervention
Decision making assessed by the MCQ
Time frame: Change from pre-intervention to 2 weeks post-intervention
Decision making assessed by the GDT
Time frame: Change from pre-intervention to 2 weeks post-intervention
Functional Status
Time frame: Change from pre-intervention to 2 weeks post-intervention
Insomnia severity
Time frame: Change from pre-intervention to 6 months post-intervention
Sleep quality assessed by the PSQI
Time frame: Change from pre-intervention to 6 months post-intervention
Sleep efficiency
Time frame: Change from pre-intervention to 6 months post-intervention
Anxiety
Time frame: Change from pre-intervention to 6 months post-intervention
Depression
Time frame: Change from pre-intervention to 6 months post-intervention
HF-related quality of life
Time frame: Change from pre-intervention to 6 months post-intervention
HF self-care
Time frame: Change from pre-intervention to 6 months post-intervention
Executive function
Time frame: Change from pre-intervention to 6 months post-intervention
Attention and psychomotor performance
Time frame: Change from pre-intervention to 6 months post-intervention
Memory
Time frame: Change from pre-intervention to 6 months post-intervention
Decision making assessed by the MCQ
Time frame: Change from pre-intervention to 6 months post-intervention
Decision making assessed by the GDT
Time frame: Change from pre-intervention to 6 months post-intervention
Functional Status
Time frame: Change from pre-intervention to 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Emery, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief treatment for Insomnia and Sleep Monitoring in people with Heart Failure and Cardiac Failure, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: Change from pre-intervention to 2 weeks post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.