Cardiac FailureHSSNCT02660385
Insomnia Self-Management in Heart Failure
A study testing Cognitive Behavioral Therapy for Insomnia and Self-Management Education for Heart Failure in people with Cardiac Failure and Heart Failure, run by Yale University at 1 site in United States.
Trial summary
Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Failure, Heart Failure, Congestive Heart Failure
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Self-Management Education for Heart Failure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2016to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- stable chronic heart failure, chronic insomnia, English speaking/reading,
Who cannot join
- untreated sleep disordered breathing or restless legs syndrome, rotating/night shift work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting the non-dominant arm end-stage renal failure, significant cognitive impairment, unstable medical or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Nursing
West Haven, Connecticut, 06516-7399
About this study
Official title: Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.
The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined.
Read more
A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education.
Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.
Read the detailed description
Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may contribute to the development and exacerbation of HF and incident mortality. It is also associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.However, insomnia is under-diagnosed and under-treated in this population.
Cognitive behavioral therapy for insomnia (CBT-I) is a multi-modal behavioral treatment focused on modifying beliefs and attitudes about sleep and is efficacious in many populations. The purposes of RCT are to evaluate the sustained effects of CBT-I, compared with HF self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention-control condition and explore the effects of CBT-I on event-free survival. We will address the following specific aims (*primary outcomes): (1) Test the sustained effects (baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks, compared with HF self-management education (attention control condition), on: (1a) *insomnia severity and self-reported and actigraph-recorded sleep characteristics (*sleep quality, *sleep efficiency, sleep latency, and duration); (1b) symptoms (*fatigue, anxiety, depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and (1c) symptom clusters [membership in clusters characterized by severity of specific symptoms; transition between clusters over time]; (2) Test the sustained effects of CBT-I on self-reported and objective functional performance; and (3) Examine the cost-effectiveness of CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival.
A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost-effectiveness analysis, and survival analysis.
- Conditions
- Cardiac Failure, Heart Failure, Congestive Heart Failure, Heart Failure, Congestive, Sleep Initiation and Maintenance Disorders, Chronic Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Self-Management Education for Heart Failure
- Keywords
- pain, insomnia, cardiac failure, sleep, fatigue, heart disease, anxiety, actigraphy, psychomotor vigilance, six minute walk, depression, cognitive behavioral therapy, self-management, self-care
- Medical subject headings
- Heart Failure, Sleep Initiation and Maintenance Disorders, Fatigue, Pain, Depression, Sleep Wake Disorders, Anxiety Disorders, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called Self-management for insomnia
This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.
Self-Management Education for Heart FailureBehavioural
This is an educational education designed to teach patients about self-management their heart failure. It includes information on medications, lifestyle, cardiac devices, diet, and when to seek assistance from a health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive behavioral therapy for insomnia (CBT-I) will be provided in a group format, led by an interventionist. CBT-I includes strategies for modifying thoughts and behaviors about sleep. Participants will be instructed on and practice methods for modifying their thoughts and behaviors about sleep and insomnia. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Heart Failure Self-Management Education | Active comparator | Heart Failure Self-management education is an intervention that will be provided by a nurse in a group format. This includes standard components, such as education about fluid and sodium management, heart failure medications, diet and physical activity. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks. Receives: Behavioral: Self-Management Education for Heart Failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change in Fatigue
The symptom of fatigue was measured with the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a. The instrument measures a range of symptoms of fatigue from mild tiredness to exhaustion that may interfere with the performance of daily activities. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Not at all") to 5 ("Very much"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more fatigue. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 33-78.
Measured: Baseline to 3 months
Change in Sleep Efficiency-measured With PSQI
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. Items 1 (bed time), 3 (wake time) are used to determine time-in-bed (the difference between Q1 and Q3). Q4 is time asleep while in bed. Sleep efficiency= (time asleep/time in bed) * 100
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change in Sleep Quality
Sleep Quality was subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score of sleep quality ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change in Sleep Efficiency-measured With Actigraphy
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency was objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants wore the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants also completed a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
Sleep efficiency=(time asleep/time in bed) * 100
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change From Baseline in Fatigue
The symptom of fatigue was measured with the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a. The instrument measures a range of symptoms of fatigue from mild tiredness to exhaustion that may interfere with the performance of daily activities. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Not at all") to 5 ("Very much"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more fatigue. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 33-78.
Measured: Baseline to 6 months and 12 months
Change From Baseline in Insomnia Severity
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 6 months and 12 months
Change From Baseline in Sleep Quality
Sleep Quality was subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 6 months and 12 months
Change From Baseline in Sleep Efficiency Measured With PSQI (%)
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. Items 1 (bed time), 3 (wake time) are used to determine time-in-bed (the difference between Q1 and Q3). Q4 is time asleep while in bed. Sleep efficiency= (time asleep/time in bed) * 100
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 6 months to 12 months
Change From Baseline in Sleep Efficiency Measured With Actigraphy
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency was objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants wore the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants also completed a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data. Sleep efficiency=(time asleep/time in bed) * 100
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 6 months and 12 months
Secondary outcomes (21)
Change in Sleep Duration
Sleep duration was objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change From Baseline in Sleep Duration
Sleep duration was objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants wore the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep duration for a two week period. Participants completed a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 6 months and 12 months
Change in Anxiety Symptoms
Anxiety symptoms were measured with the PROMIS - Anxiety V1.- Short Form 8a. The instrument measures fear (worry, panic), anxious misery (e.g., dread), hyperarousal (e.g., tension, restlessness), and somatic symptoms (e.g., dizziness). The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Never") to 5 ("Always"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more anxiety symptoms. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 37-84.
Measured: Baseline to 3 months
Change From Baseline in Anxiety Symptoms
Anxiety symptoms were measured with the PROMIS - Anxiety V1.- Short Form 8a. The instrument measures fear (worry, panic), anxious misery (e.g., dread), hyperarousal (e.g., tension, restlessness), and somatic symptoms (e.g., dizziness). The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Never") to 5 ("Always"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more anxiety symptoms. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 37-84.
Measured: Baseline to 6 months and 12 months
Change in Depressive Symptoms
Depressive symptoms were measured with the PROMIS - Depression V1.- Short Form 8a. The instrument measures negative mood (sadness), views of self (worthlessness), and social cognition (loneliness), and decreased positive affect and engagement. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Never") to 5 ("Always"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more depressive symptoms. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 38-82.
Measured: Baseline to 3 months
Change From Baseline in Depressive Symptoms
Depressive symptoms were measured with the PROMIS - Depression V1.- Short Form 8a. The instrument measures negative mood (sadness), views of self (worthlessness), and social cognition (loneliness), and decreased positive affect and engagement. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Never") to 5 ("Always"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more depressive symptoms. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 38-82.
Measured: Baseline to 6 months and 12 months
Change in Sleepiness
Sleepiness was measured using the Epworth Sleepiness Scale (ESS). The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change From Baseline in Sleepiness
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS). The ESS is an 8-item self report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 6 months and 12 months
Change in Dyspnea
Symptoms of dyspnea were measured with the Multidimensional Assessment of Dyspnea Scale, a 16-item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living. The range of possible scores are between 4 and 50. To calculate the Global Dyspnea Index (GDI), we converted item 15 to a 0 - 10 scale by multiplying each score by 2.5 and then finding the sum of items 1, 2, and 3, and average 4 - 14. We did not assign a score to items 4 - 14 if the respondent gave a response of "do not do activity." If a respondent selected "no shortness of breath" on item 1, we assigned a zero to items 2 - 16. Item 16 is not included in the GDI.
Measured: Baseline to 3 months
Change From Baseline in Dyspnea
Symptoms of dyspnea were measured with the Multidimensional Assessment of Dyspnea Scale, a 16-item instrument to measure self-reported shortness of breath and the effect of shortness of breath on daily activities. The items are used to calculate a global dyspnea index, with higher scores indicating more severe dyspnea and greater impact on activities of daily living. The range of possible scores are between 4 and 50. To calculate the Global Dyspnea Index (GDI), we converted item 15 to a 0 - 10 scale by multiplying each score by 2.5 and then finding the sum of items 1, 2, and 3, and average 4 - 14. We did not assign a score to items 4 - 14 if the respondent gave a response of "do not do activity." If a respondent selected "no shortness of breath" on item 1, we assigned a zero to items 2 - 16. Item 16 is not included in the GDI.
Measured: Baseline to 6 months and 12 months
Change in Psychomotor Vigilance
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
Measured: Baseline to 3 months
Change From Baseline in Psychomotor Vigilance
Psychomotor vigilance will be measured with the Psychomotor Vigilance Test (PVT), a widely used measure of behavioral alertness that is highly sensitive to changes related to sleep deprivation. The 10-minute PVT measures sustained or vigilant attention by recording response times to visual (or auditory) stimuli that occur at random inter-stimulus intervals. Scoring includes a numerical measure of sleepiness by counting the number of lapses in attention of the tested subject.
Measured: Baseline to 6 months and 12 months
Change in Functional Performance
Functional performance was measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health. Physical functioning scores were calculated using the Quality Metric Outcomes TM Scoring Software 4.5, which uses norm-based scoring. The range of possible scores is from 0-100; the typical range of norm based physical functioning is 20 to 60.
Measured: Baseline to 3 months
Change From Baseline in Functional Performance
Functional performance was measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health. Physical functioning scores were calculated using the Quality Metric Outcomes TM Scoring Software 4.5, which uses norm-based scoring. The range of possible scores is from 0-100; the typical range of norm based physical functioning is 20 to 60.
Measured: Baseline to 6 months and 12 months
Change in Distance (Feet) Traveled During Six Minute Walk Test
Functional capacity was objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Measured: Baseline to 3 months
Change in Distance (Feet) Traveled During Six Minute Walk Test
Functional capacity was objectively measured using the Six Minute Walk Test, which measures the distance that an individual can quickly walk on a flat, hard surface in a period of 6 minutes. The test is self-paced, and evaluates the global and integrated responses of all physiological systems involved during exercise. Participants choose their own intensity of exercise and are allowed to stop and rest during the test. Results are reported as an absolute value (distance walked), and interpreted according to change in functional capacity over time.
Measured: Baseline to 6 months and 12 months
Cost Effectiveness
Cost effectiveness was evaluated in terms of direct costs for health care resources used (ED visits, hospitalizations, inpatient and outpatient visits), as well as indirect costs (time missed from work, travel, and self-management and CBT-I activities). Out-of-pocket expenses were estimated using self-reported medical history health care resource use data (e.g., visits to health care providers, hospitalizations, emergency department visits). Information on costs were obtained by self-report and validated through the EMR, hospital cost accounting database, and the Medicare fee schedule.
Measured: 12 months post treatment
Change From Baseline in Sleep Latency (Minutes)
Sleep latency is the time it takes to fall asleep after turning the lights out.
Measured: Baseline to 6 months and 12 months
Change in Sleep Latency
Sleep latency is the amount of time it takes to fall asleep after turning off the lights.
Measured: Baseline to 3 months
Change in Sleep Related Impairment
We used the 8-item PROMIS Sleep-Related Impairment questionnaire to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Not at all") to 5 ("Very much"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more sleep related impairment. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe.
Measured: Baseline to 3 months
Change From Baseline in Sleep Related Impairment
We used the 8-item PROMIS Sleep-Related Impairment questionnaire to measure self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Not at all") to 5 ("Very much"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more sleep related impairment. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe.
Measured: Baseline to 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study start7 Mar 2016
- Primary completion1 Aug 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiac FailureStudies of the same condition, open and under way.
- More trials run by Yale 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
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Nancy S Redeker, PhD, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660385
- Sponsor's protocol ID
- 0904005041a
- Other IDs
- R01NR016191
- Acronym
- HSS
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2016
- Last updated
- 9 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will make the data collected for the primary study aims (participant demographics, clinical characteristics, treatment group assignment and primary study outcomes (insomnia severity, sleep quality, actigraph-recorded sleep characteristics), daytime symptoms, and functional performance. We will also make the health care utilization/cost data available.
Publications
O'Connell M, Feder SL, Nwanaji-Enwerem U, Redeker NS. Focus Group Study of Heart Failure Nurses' Perceptions of the Feasibility of Cognitive Behavioral Therapy for Insomnia. Nurs Res. 2024 Mar-Apr 01;73(2):109-117. doi: 10.1097/NNR.0000000000000706. Epub 2023 Nov 9.
PubMed 37967228Jeon S, Conley S, Hollenbeak C, O'Connell M, Wang Z, Tocchi C, Redeker NS. Rest-activity rhythms predict time to hospitalizations and emergency department visits among participants in a randomized control of adults with heart failure and insomnia. Sleep Med. 2023 Aug;108:1-7. doi: 10.1016/j.sleep.2023.05.019. Epub 2023 May 27.
PubMed 37301192Redeker NS, Conley S, O'Connell M, Geer JH, Yaggi H, Jeon S. Sleep-related predictors of cognition among adults with chronic insomnia and heart failure enrolled in a randomized controlled trial of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2023 Jun 1;19(6):1073-1081. doi: 10.5664/jcsm.10498.
PubMed 36740924O'Connell M, DeSanto Iennaco J, Linsky S, Jeon S, Conley S, Gaiser E 3rd, Redeker NS. Treatment Fidelity in a Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia in Heart Failure. Nurs Res. 2022 Nov-Dec 01;71(6):459-468. doi: 10.1097/NNR.0000000000000616. Epub 2022 Aug 20.
PubMed 35997691O'Connell M, Jeon S, Conley S, Linsky S, Redeker NS. Coping, symptoms, and insomnia among people with heart failure during the COVID-19 pandemic. Eur J Cardiovasc Nurs. 2023 Apr 12;22(3):291-298. doi: 10.1093/eurjcn/zvac072.
PubMed 35938348Breazeale S, Jeon S, Hwang Y, O'Connell M, Nwanaji-Enwerem U, Linsky S, Yaggi HK, Jacoby DL, Conley S, Redeker NS. Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia. Nurs Res. 2022 May-Jun 01;71(3):189-199. doi: 10.1097/NNR.0000000000000585.
PubMed 35149627Redeker NS, Yaggi HK, Jacoby D, Hollenbeak CS, Breazeale S, Conley S, Hwang Y, Iennaco J, Linsky S, Nwanaji-Enwerem U, O'Connell M, Jeon S. Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study. Sleep. 2022 Jan 11;45(1):zsab252. doi: 10.1093/sleep/zsab252.
PubMed 34657160Redeker NS, Knies AK, Hollenbeak C, Klar Yaggi H, Cline J, Andrews L, Jacoby D, Sullivan A, O'Connell M, Iennaco J, Finoia L, Jeon S. Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:16-23. doi: 10.1016/j.cct.2017.01.009. Epub 2017 Jan 31.
PubMed 28159703
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
- ClinicalTrials.gov ID
- NCT02660385
- Acronym / sponsor ID
- HSS / 0904005041a
- Conditions
- Cardiac Failure, Heart Failure, Congestive Heart Failure, Heart Failure, Congestive, Sleep Initiation and Maintenance Disorders, Chronic Insomnia
- Keywords
- pain, insomnia, cardiac failure, sleep, fatigue, heart disease, anxiety, actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Milton S. Hershey Medical Center, National Institute of Nursing Research (NINR)
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Posted 9 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.
The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined.
A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education.
Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.
Detailed description
Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may contribute to the development and exacerbation of HF and incident mortality. It is also associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.However, insomnia is under-diagnosed and under-treated in this population.
Cognitive behavioral therapy for insomnia (CBT-I) is a multi-modal behavioral treatment focused on modifying beliefs and attitudes about sleep and is efficacious in many populations. The purposes of RCT are to evaluate the sustained effects of CBT-I, compared with HF self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention-control condition and explore the effects of CBT-I on event-free survival. We will address the following specific aims (*primary outcomes): (1) Test the sustained effects (baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks, compared with HF self-management education (attention control condition), on: (1a) *insomnia severity and self-reported and actigraph-recorded sleep characteristics (*sleep quality, *sleep efficiency, sleep latency, and duration); (1b) symptoms (*fatigue, anxiety, depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and (1c) symptom clusters [membership in clusters characterized by severity of specific symptoms; transition between clusters over time]; (2) Test the sustained effects of CBT-I on self-reported and objective functional performance; and (3) Examine the cost-effectiveness of CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival.
A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost-effectiveness analysis, and survival analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive behavioral therapy for insomnia (CBT-I) will be provided in a group format, led by an interventionist. CBT-I includes strategies for modifying thoughts and behaviors about sleep. Participants will be instructed on and practice methods for modifying their thoughts and behaviors about sleep and insomnia. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks. |
| Heart Failure Self-Management Education | Active comparator | Behavioral: Self-Management Education for Heart FailureHeart Failure Self-management education is an intervention that will be provided by a nurse in a group format. This includes standard components, such as education about fluid and sodium management, heart failure medications, diet and physical activity. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable chronic heart failure, chronic insomnia, English speaking/reading,
Key exclusion criteria (1 listed)
- untreated sleep disordered breathing or restless legs syndrome, rotating/night shift work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting the non-dominant arm end-stage renal failure, significant cognitive impairment, unstable medical or psychiatric disorders
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 |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaAlso: Self-management for insomniaThis behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format. | Behavioural | Cognitive Behavioral Therapy |
| Self-Management Education for Heart FailureThis is an educational education designed to teach patients about self-management their heart failure. It includes information on medications, lifestyle, cardiac devices, diet, and when to seek assistance from a health care provider. | Behavioural | Heart Failure Self-Management Education |
Primary outcome
Change in Insomnia Severity
Time frame: Baseline to 3 months
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia. For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change in Fatigue
Time frame: Baseline to 3 months
The symptom of fatigue was measured with the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a. The instrument measures a range of symptoms of fatigue from mild tiredness to exhaustion that may interfere with the performance of daily activities. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Not at all") to 5 ("Very much"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more fatigue. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 33-78.
Change in Sleep Efficiency-measured With PSQI
Time frame: Baseline to 3 months
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. Items 1 (bed time), 3 (wake time) are used to determine time-in-bed (the difference between Q1 and Q3). Q4 is time asleep while in bed. Sleep efficiency= (time asleep/time in bed) * 100 For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change in Sleep Quality
Time frame: Baseline to 3 months
Sleep Quality was subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score of sleep quality ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change in Sleep Efficiency-measured With Actigraphy
Time frame: Baseline to 3 months
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency was objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants wore the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants also completed a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data. Sleep efficiency=(time asleep/time in bed) * 100 For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 3 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change From Baseline in Fatigue
Time frame: Baseline to 6 months and 12 months
The symptom of fatigue was measured with the PROMIS Item Bank v1.0 - Fatigue - Short Form 8a. The instrument measures a range of symptoms of fatigue from mild tiredness to exhaustion that may interfere with the performance of daily activities. The instrument uses a 7-day time frame and a 5-point rating scale that ranges from 1 ("Not at all") to 5 ("Very much"). The measure uses a T-score metric in which 50 is the mean of a relevant reference population (the general population) and 10 is the standard deviation (SD) of the population. Higher scores mean more fatigue. To find the total raw score we summed the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40. We used the score conversion table to translate the total raw score into a T-score for each participant. The T-scores are interpreted as follows: Less than 55 = None to slight 55.0-59.9 = Mild 60.0-69.9 = Moderate 70 and over = Severe. The range of scores is 33-78.
Change From Baseline in Insomnia Severity
Time frame: Baseline to 6 months and 12 months
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, sub-threshold insomnia, moderate insomnia or severe insomnia. For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change From Baseline in Sleep Quality
Time frame: Baseline to 6 months and 12 months
Sleep Quality was subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change From Baseline in Sleep Efficiency Measured With PSQI (%)
Time frame: Baseline to 6 months to 12 months
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. Items 1 (bed time), 3 (wake time) are used to determine time-in-bed (the difference between Q1 and Q3). Q4 is time asleep while in bed. Sleep efficiency= (time asleep/time in bed) * 100 For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
Change From Baseline in Sleep Efficiency Measured With Actigraphy
Time frame: Baseline to 6 months and 12 months
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency was objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants wore the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants also completed a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data. Sleep efficiency=(time asleep/time in bed) * 100 For clarification, when results were entered, the outcome measure title was edited to include "change in" and the time frame was changed to Baseline to 6 and 12 months. When registered, the original time frame did not accurately portray the amount of time in which follow up data were collected.
21 secondary outcomes
Change in Sleep Duration
Time frame: Baseline to 3 months
Change From Baseline in Sleep Duration
Time frame: Baseline to 6 months and 12 months
Change in Anxiety Symptoms
Time frame: Baseline to 3 months
Change From Baseline in Anxiety Symptoms
Time frame: Baseline to 6 months and 12 months
Change in Depressive Symptoms
Time frame: Baseline to 3 months
Change From Baseline in Depressive Symptoms
Time frame: Baseline to 6 months and 12 months
Change in Sleepiness
Time frame: Baseline to 3 months
Change From Baseline in Sleepiness
Time frame: Baseline to 6 months and 12 months
Change in Dyspnea
Time frame: Baseline to 3 months
Change From Baseline in Dyspnea
Time frame: Baseline to 6 months and 12 months
Change in Psychomotor Vigilance
Time frame: Baseline to 3 months
Change From Baseline in Psychomotor Vigilance
Time frame: Baseline to 6 months and 12 months
Change in Functional Performance
Time frame: Baseline to 3 months
Change From Baseline in Functional Performance
Time frame: Baseline to 6 months and 12 months
Change in Distance (Feet) Traveled During Six Minute Walk Test
Time frame: Baseline to 3 months
Change in Distance (Feet) Traveled During Six Minute Walk Test
Time frame: Baseline to 6 months and 12 months
Cost Effectiveness
Time frame: 12 months post treatment
Change From Baseline in Sleep Latency (Minutes)
Time frame: Baseline to 6 months and 12 months
Change in Sleep Latency
Time frame: Baseline to 3 months
Change in Sleep Related Impairment
Time frame: Baseline to 3 months
Change From Baseline in Sleep Related Impairment
Time frame: Baseline to 6 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37967228O'Connell M, Feder SL, Nwanaji-Enwerem U, Redeker NS. Focus Group Study of Heart Failure Nurses' Perceptions of the Feasibility of Cognitive Behavioral Therapy for Insomnia. Nurs Res. 2024 Mar-Apr 01;73(2):109-117. doi: 10.1097/NNR.0000000000000706. Epub 2023 Nov 9.
- Derived from this study: PubMed 37301192Jeon S, Conley S, Hollenbeak C, O'Connell M, Wang Z, Tocchi C, Redeker NS. Rest-activity rhythms predict time to hospitalizations and emergency department visits among participants in a randomized control of adults with heart failure and insomnia. Sleep Med. 2023 Aug;108:1-7. doi: 10.1016/j.sleep.2023.05.019. Epub 2023 May 27.
- Derived from this study: PubMed 36740924Redeker NS, Conley S, O'Connell M, Geer JH, Yaggi H, Jeon S. Sleep-related predictors of cognition among adults with chronic insomnia and heart failure enrolled in a randomized controlled trial of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2023 Jun 1;19(6):1073-1081. doi: 10.5664/jcsm.10498.
- Derived from this study: PubMed 35997691O'Connell M, DeSanto Iennaco J, Linsky S, Jeon S, Conley S, Gaiser E 3rd, Redeker NS. Treatment Fidelity in a Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia in Heart Failure. Nurs Res. 2022 Nov-Dec 01;71(6):459-468. doi: 10.1097/NNR.0000000000000616. Epub 2022 Aug 20.
- Derived from this study: PubMed 35938348O'Connell M, Jeon S, Conley S, Linsky S, Redeker NS. Coping, symptoms, and insomnia among people with heart failure during the COVID-19 pandemic. Eur J Cardiovasc Nurs. 2023 Apr 12;22(3):291-298. doi: 10.1093/eurjcn/zvac072.
- Derived from this study: PubMed 35149627Breazeale S, Jeon S, Hwang Y, O'Connell M, Nwanaji-Enwerem U, Linsky S, Yaggi HK, Jacoby DL, Conley S, Redeker NS. Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia. Nurs Res. 2022 May-Jun 01;71(3):189-199. doi: 10.1097/NNR.0000000000000585.
- Derived from this study: PubMed 34657160Redeker NS, Yaggi HK, Jacoby D, Hollenbeak CS, Breazeale S, Conley S, Hwang Y, Iennaco J, Linsky S, Nwanaji-Enwerem U, O'Connell M, Jeon S. Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study. Sleep. 2022 Jan 11;45(1):zsab252. doi: 10.1093/sleep/zsab252.
- Derived from this study: PubMed 28159703Redeker NS, Knies AK, Hollenbeak C, Klar Yaggi H, Cline J, Andrews L, Jacoby D, Sullivan A, O'Connell M, Iennaco J, Finoia L, Jeon S. Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:16-23. doi: 10.1016/j.cct.2017.01.009. Epub 2017 Jan 31.
- Individual participant dataSharing planned: Yes. We will make the data collected for the primary study aims (participant demographics, clinical characteristics, treatment group assignment and primary study outcomes (insomnia severity, sleep quality, actigraph-recorded sleep characteristics), daytime symptoms, and functional performance. We will also make the health care utilization/cost data available.
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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.
Nancy S Redeker, PhD principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia and Self-Management Education for Heart Failure in people with Cardiac Failure and Heart Failure, run by Yale 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 1 inclusion and 1 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 9 Feb 2023. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Insomnia Severity (time frame: Baseline to 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660385, which also lists 8 linked publications.
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 9 Feb 2023.