Insomnia Self-Management in Heart Failure
HSS
Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
2 other identifiers
interventional
195
1 country
1
Brief Summary
Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2016
CompletedFirst Posted
Study publicly available on registry
January 21, 2016
CompletedStudy Start
First participant enrolled
March 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedResults Posted
Study results publicly available
February 9, 2023
CompletedFebruary 9, 2023
January 1, 2023
4.4 years
January 14, 2016
August 25, 2022
January 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
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
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
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
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
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
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
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
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
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 Outcomes (21)
Change in Sleep Duration
Baseline to 3 months
Change From Baseline in Sleep Duration
Baseline to 6 months and 12 months
Change in Anxiety Symptoms
Baseline to 3 months
Change From Baseline in Anxiety Symptoms
Baseline to 6 months and 12 months
Change in Depressive Symptoms
Baseline to 3 months
- +16 more secondary outcomes
Study Arms (2)
Cognitive Behavioral Therapy
EXPERIMENTALCognitive behavioral therapy for insomnia (CBT-I) will be provided in a group format, led by an interventionist. CBT-I includes strategies for modifying thoughts and behaviors about sleep. Participants will be instructed on and practice methods for modifying their thoughts and behaviors about sleep and insomnia. Participants will participate in four sessions, conducted every other week for 8 weeks. They will receive a call from the interventionist on intervening weeks.
Heart Failure Self-Management Education
ACTIVE COMPARATORHeart 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.
Interventions
This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.
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.
Eligibility Criteria
You may qualify if:
- stable chronic heart failure, chronic insomnia, English speaking/reading,
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Milton S. Hershey Medical Centercollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
Yale University School of Nursing
West Haven, Connecticut, 06516-7399, United States
Related Publications (8)
O'Connell M, Feder SL, Nwanaji-Enwerem U, Redeker NS. Focus Group Study of Heart Failure Nurses' Perceptions of the Feasibility of Cognitive Behavioral Therapy for Insomnia. Nurs Res. 2024 Mar-Apr 01;73(2):109-117. doi: 10.1097/NNR.0000000000000706. Epub 2023 Nov 9.
PMID: 37967228DERIVEDJeon S, Conley S, Hollenbeak C, O'Connell M, Wang Z, Tocchi C, Redeker NS. Rest-activity rhythms predict time to hospitalizations and emergency department visits among participants in a randomized control of adults with heart failure and insomnia. Sleep Med. 2023 Aug;108:1-7. doi: 10.1016/j.sleep.2023.05.019. Epub 2023 May 27.
PMID: 37301192DERIVEDRedeker NS, Conley S, O'Connell M, Geer JH, Yaggi H, Jeon S. Sleep-related predictors of cognition among adults with chronic insomnia and heart failure enrolled in a randomized controlled trial of cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2023 Jun 1;19(6):1073-1081. doi: 10.5664/jcsm.10498.
PMID: 36740924DERIVEDO'Connell M, DeSanto Iennaco J, Linsky S, Jeon S, Conley S, Gaiser E 3rd, Redeker NS. Treatment Fidelity in a Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia in Heart Failure. Nurs Res. 2022 Nov-Dec 01;71(6):459-468. doi: 10.1097/NNR.0000000000000616. Epub 2022 Aug 20.
PMID: 35997691DERIVEDO'Connell M, Jeon S, Conley S, Linsky S, Redeker NS. Coping, symptoms, and insomnia among people with heart failure during the COVID-19 pandemic. Eur J Cardiovasc Nurs. 2023 Apr 12;22(3):291-298. doi: 10.1093/eurjcn/zvac072.
PMID: 35938348DERIVEDBreazeale S, Jeon S, Hwang Y, O'Connell M, Nwanaji-Enwerem U, Linsky S, Yaggi HK, Jacoby DL, Conley S, Redeker NS. Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia. Nurs Res. 2022 May-Jun 01;71(3):189-199. doi: 10.1097/NNR.0000000000000585.
PMID: 35149627DERIVEDRedeker NS, Yaggi HK, Jacoby D, Hollenbeak CS, Breazeale S, Conley S, Hwang Y, Iennaco J, Linsky S, Nwanaji-Enwerem U, O'Connell M, Jeon S. Cognitive behavioral therapy for insomnia has sustained effects on insomnia, fatigue, and function among people with chronic heart failure and insomnia: the HeartSleep Study. Sleep. 2022 Jan 11;45(1):zsab252. doi: 10.1093/sleep/zsab252.
PMID: 34657160DERIVEDRedeker NS, Knies AK, Hollenbeak C, Klar Yaggi H, Cline J, Andrews L, Jacoby D, Sullivan A, O'Connell M, Iennaco J, Finoia L, Jeon S. Cognitive behavioral therapy for insomnia in stable heart failure: Protocol for a randomized controlled trial. Contemp Clin Trials. 2017 Apr;55:16-23. doi: 10.1016/j.cct.2017.01.009. Epub 2017 Jan 31.
PMID: 28159703DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Meghan O'Connell, Program Manager
- Organization
- University of Connecticut/formerly Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy S Redeker, PhD
Yale University School of Nursing
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2016
First Posted
January 21, 2016
Study Start
March 7, 2016
Primary Completion
August 1, 2020
Study Completion
November 30, 2021
Last Updated
February 9, 2023
Results First Posted
February 9, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be made available starting in January 2025
- Access Criteria
- Access to the data can be requested through contact with the principal investigators, Nancy S. Redeker, PhD, RN, FAHA, FAAN Nancy.redeker@yale.edu
We will make the data collected for the primary study aims (participant demographics, clinical characteristics, treatment group assignment and primary study outcomes (insomnia severity, sleep quality, actigraph-recorded sleep characteristics), daytime symptoms, and functional performance. We will also make the health care utilization/cost data available.