Pain Clinical Trial
— HSSOfficial title:
Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
| Verified date | January 2023 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 195 |
| Est. completion date | November 30, 2021 |
| Est. primary completion date | August 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - stable chronic heart failure, chronic insomnia, English speaking/reading, Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Yale University School of Nursing | West Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University | Milton S. Hershey Medical Center, National Institute of Nursing Research (NINR) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Baseline to 3 months | |
| Primary | 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. | Baseline to 3 months | |
| Primary | 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. |
Baseline to 3 months | |
| Primary | 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. |
Baseline to 3 months | |
| Primary | 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. |
Baseline to 3 months | |
| Primary | 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. | Baseline to 6 months and 12 months | |
| Primary | 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. |
Baseline to 6 months and 12 months | |
| Primary | 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. |
Baseline to 6 months and 12 months | |
| Primary | 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. |
Baseline to 6 months to 12 months | |
| Primary | 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. |
Baseline to 6 months and 12 months | |
| Secondary | 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. |
Baseline to 3 months | |
| Secondary | 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. |
Baseline to 6 months and 12 months | |
| Secondary | 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. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months | |
| Secondary | 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. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months | |
| Secondary | 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. |
Baseline to 3 months | |
| Secondary | 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. |
Baseline to 6 months and 12 months | |
| Secondary | 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. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months | |
| Secondary | 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. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months | |
| Secondary | 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. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months | |
| Secondary | 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. |
Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months | |
| Secondary | 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. | 12 months post treatment | |
| Secondary | Change From Baseline in Sleep Latency (Minutes) | Sleep latency is the time it takes to fall asleep after turning the lights out. | Baseline to 6 months and 12 months | |
| Secondary | Change in Sleep Latency | Sleep latency is the amount of time it takes to fall asleep after turning off the lights. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 3 months | |
| Secondary | 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. | Baseline to 6 months and 12 months |
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