Trial Outcomes & Findings for Insomnia Self-Management in Heart Failure (NCT NCT02660385)

NCT ID: NCT02660385

Last Updated: 2023-02-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 195 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2023-02-09

Participant Flow

We used multiple recruitment strategies including clinic-based recruitment, letters to patients identified from electronic databases, the patient portal, brochures and posters placed in clinics, presentations to heart failure support groups, and online advertising

195 enrolled. Six participants dropped out prior to randomization, and 189 were randomized to HH and HS conditions. Fourteen completed the intervention or control condition but dropped out or died before follow-up assessments began. 175 completed at least one follow-up assessment.

Participant milestones

Measure	Cognitive Behavioral Therapy 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education 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. Self-Management Education for Heart Failure: 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.
Overall Study STARTED	100	89
Overall Study COMPLETED	91	84
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Row total does not differ from Overall

Baseline characteristics by cohort

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.	Total n=175 Participants Total of all reporting groups
Age, Continuous	62.0 years STANDARD_DEVIATION 13.1 • n=5 Participants • Row total does not differ from Overall	64.1 years STANDARD_DEVIATION 12.6 • n=7 Participants • Row total does not differ from Overall	63.0 years STANDARD_DEVIATION 12.9 • n=5 Participants • Row total does not differ from Overall
Sex: Female, Male Female	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	47 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants	80 Participants n=7 Participants	166 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	64 Participants n=7 Participants	133 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Insomnia Severity	-6.60 score on a scale Standard Deviation 5.23	-3.46 score on a scale Standard Deviation 5.18

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Fatigue	-3.24 T-score Standard Deviation 3.16	-1.13 T-score Standard Deviation 8.05

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleep Efficiency-measured With PSQI	4.87 percent Standard Deviation 17.41	-1.96 percent Standard Deviation 15.41

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleep Quality	-2.78 score on a scale Standard Deviation 3.16	-0.51 score on a scale Standard Deviation 3.31

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleep Efficiency-measured With Actigraphy	-0.5 percent Standard Deviation 5.8	0.3 percent Standard Deviation 7.2

PRIMARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Fatigue 6 month change	-3.16 T-score Standard Error 0.70	-1.37 T-score Standard Error 0.72
Change From Baseline in Fatigue 12 month change	-4.26 T-score Standard Error 0.67	-1.49 T-score Standard Error 0.72

PRIMARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Insomnia Severity 6 month change	-6.63 score on a scale Standard Error 0.48	-4.06 score on a scale Standard Error 0.49
Change From Baseline in Insomnia Severity 12 month change	-6.69 score on a scale Standard Error 0.47	-4.57 score on a scale Standard Error 0.50

PRIMARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleep Quality 6 month change	-3.02 score on a scale Standard Error 0.31	-0.92 score on a scale Standard Error 0.32
Change From Baseline in Sleep Quality 12 month change	-2.89 score on a scale Standard Error 0.32	-1.36 score on a scale Standard Error 0.34

PRIMARY outcome

Timeframe: Baseline to 6 months to 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleep Efficiency Measured With PSQI (%) 6 month change	5.21 percent Standard Error 1.51	0.91 percent Standard Error 1.52
Change From Baseline in Sleep Efficiency Measured With PSQI (%) 12 month change	4.91 percent Standard Error 1.43	1.17 percent Standard Error 1.49

PRIMARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleep Efficiency Measured With Actigraphy 6 month change	-0.53 percent Standard Error 0.51	0.17 percent Standard Error 0.57
Change From Baseline in Sleep Efficiency Measured With Actigraphy 12 month change	-0.44 percent Standard Error 0.58	0.01 percent Standard Error 0.59

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleep Duration	0.24 hours Standard Deviation 1.73	-0.44 hours Standard Deviation 2.11

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleep Duration 12 month change	0.03 hours Standard Error 0.11	-0.18 hours Standard Error 0.12
Change From Baseline in Sleep Duration 6 month change	0.21 hours Standard Error 0.12	-0.18 hours Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Anxiety Symptoms	-2.08 T-score Standard Deviation 5.98	-0.32 T-score Standard Deviation 7.16

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Anxiety Symptoms 6 month change	-2.73 T-score Standard Error 0.73	-1.67 T-score Standard Error 0.74
Change From Baseline in Anxiety Symptoms 12 month change	-2.85 T-score Standard Error 0.71	-1.90 T-score Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Depressive Symptoms	-1.93 T-score Standard Deviation 6.83	-2.50 T-score Standard Deviation 6.37

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Depressive Symptoms 6 month change	-1.55 T-score Standard Error 0.66	-2.549 T-score Standard Error 0.68
Change From Baseline in Depressive Symptoms 12 month change	-1.11 T-score Standard Error 0.64	-2.71 T-score Standard Error 0.68

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleepiness	-1.39 score on a scale Standard Deviation 4.21	-0.23 score on a scale Standard Deviation 3.37

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleepiness 6 month change	-1.99 score on a scale Standard Error 0.37	-0.68 score on a scale Standard Error 0.37
Change From Baseline in Sleepiness 12 month change	-2.15 score on a scale Standard Error 0.35	-0.84 score on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Dyspnea	-0.77 score on a scale Standard Deviation 8.5	0.34 score on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Dyspnea 6 month change	-0.12 score on a scale Standard Error 0.95	1.20 score on a scale Standard Error 0.94
Change From Baseline in Dyspnea 12 month change	-1.32 score on a scale Standard Error 0.93	0.41 score on a scale Standard Error 0.95

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Psychomotor Vigilance	-0.10 number of lapses Standard Deviation 0.87	-0.30 number of lapses Standard Deviation 0.98

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: modified intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Psychomotor Vigilance 6 month change	-0.16 number of lapses Standard Error 0.09	-0.55 number of lapses Standard Error 0.09
Change From Baseline in Psychomotor Vigilance 12 month change	-0.25 number of lapses Standard Error 0.09	-0.48 number of lapses Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified Intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Functional Performance	-0.79 score on a scale Standard Deviation 13.5	1.17 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Functional Performance 6 month change	-0.61 score on a scale Standard Error 1.36	1.40 score on a scale Standard Error 1.40
Change From Baseline in Functional Performance 12 month change	0.06 score on a scale Standard Error 1.40	2.56 score on a scale Standard Error 1.46

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Distance (Feet) Traveled During Six Minute Walk Test	74.7 Feet Standard Deviation 236.2	61.6 Feet Standard Deviation 156.3

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Intention to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Distance (Feet) Traveled During Six Minute Walk Test 6 month change	101.0 feet Standard Error 17.0	44.0 feet Standard Error 16.6
Change in Distance (Feet) Traveled During Six Minute Walk Test 12 month change	117.4 feet Standard Error 18.1	61.3 feet Standard Error 17.7

SECONDARY outcome

Timeframe: 12 months post treatment

Population: Participants in trial who had complete self-reported indirect cost data.

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=79 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=71 Participants 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. Self-Management Education for Heart Failure: 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.
Cost Effectiveness Cardiology visits	32 dollars Interval 16.0 to 48.0	42 dollars Interval 18.0 to 65.0
Cost Effectiveness Primary care visits	891 dollars Interval 684.0 to 1097.0	1014 dollars Interval 745.0 to 1282.0
Cost Effectiveness Other specialist visits	257 dollars Interval 145.0 to 370.0	235.69 dollars Interval 159.0 to 313.0
Cost Effectiveness Emergency department visits	34 dollars Interval -6.0 to 75.0	23 dollars Interval -2.0 to 48.0
Cost Effectiveness Indirect costs	23 dollars Interval 13.0 to 33.0	14 dollars Interval 6.0 to 22.0
Cost Effectiveness out-of-pocket costs	114 dollars Interval 75.0 to 153.0	93 dollars Interval 50.0 to 136.0
Cost Effectiveness Total costs	7813 dollars Interval 5660.0 to 9966.0	7538 dollars Interval 5488.0 to 9588.0
Cost Effectiveness Inpatient admissions	6495 dollars Interval 4565.0 to 8426.0	6140 dollars Interval 4160.0 to 8120.0

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Intention to treat

Sleep latency is the time it takes to fall asleep after turning the lights out.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleep Latency (Minutes) 6 month change	-14.06 minutes Standard Error 2.24	-0.17 minutes Standard Error 2.30
Change From Baseline in Sleep Latency (Minutes) 12 month change	-10.86 minutes Standard Error 2.09	-1.83 minutes Standard Error 2.19

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Intention to treat

Sleep latency is the amount of time it takes to fall asleep after turning off the lights.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleep Latency	-4.39 minutes Standard Deviation 43.97	-2.11 minutes Standard Deviation 44.28

SECONDARY outcome

Timeframe: Baseline to 3 months

Population: Modified Intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change in Sleep Related Impairment	-8.56 T-score Standard Deviation 9.5	-7.54 T-score Standard Deviation 11.4

SECONDARY outcome

Timeframe: Baseline to 6 months and 12 months

Population: Modified intent to treat

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.

Outcome measures

Measure	Cognitive Behavioral Therapy n=91 Participants 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. Cognitive Behavioral Therapy for Insomnia: This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.	Heart Failure Self-Management Education n=84 Participants 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. Self-Management Education for Heart Failure: 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.
Change From Baseline in Sleep Related Impairment 6 month change	-10.23 T-score Standard Error 1.03	-9.54 T-score Standard Error 1.08
Change From Baseline in Sleep Related Impairment 12 month change	-10.74 T-score Standard Error 0.98	-10.23 T-score Standard Error 1.05

Adverse Events

Cognitive Behavioral Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heart Failure Self-Management Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Meghan O'Connell, Program Manager

University of Connecticut/formerly Yale University

Phone: 860-634-4152

Email: meghan.oconnell@uconn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place