Clinical trial NCT02660385: Insomnia Self-Management in Heart Failure
Official title: Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Failure
Heart Failure
Congestive Heart Failure
Heart Failure, Congestive
Sleep Initiation and Maintenance Disorders
Chronic Insomnia
Disorders of Initiating and Maintaining Sleep
Fatigue
Pain
Depressive Symptoms
Sleep Disorders
Anxiety
Keywords: pain
insomnia
cardiac failure
sleep
fatigue
heart disease
anxiety
actigraphy
psychomotor vigilance
six minute walk
depression
cognitive behavioral therapy
self-management
self-care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Milton S. Hershey Medical Center
name: National Institute of Nursing Research (NINR)
First posted: 2016-01-21
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Almost 75% of HF patients, a group of about 5.1 million Americans who have poor function and high levels of morbidity and mortality, report poor sleep. As many as 25-56% of HF patients report chronic insomnia (difficulty initiating or maintaining sleep or waking early in the morning, with non-restorative sleep that persists for at least a month). Chronic insomnia may contribute to the development and exacerbation of HF and incident mortality. It is also associated with common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance.However, insomnia is under-diagnosed and under-treated in this population.

Cognitive behavioral therapy for insomnia (CBT-I) is a multi-modal behavioral treatment focused on modifying beliefs and attitudes about sleep and is efficacious in many populations. The purposes of RCT are to evaluate the sustained effects of CBT-I, compared with HF self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention-control condition and explore the effects of CBT-I on event-free survival. We will address the following specific aims (\*primary outcomes): (1) Test the sustained effects (baseline - 2 weeks, 6, 9, 12 months) of CBT-I provided in 4 group sessions over 8 weeks, compared with HF self-management education (attention control condition), on: (1a) \*insomnia severity and self-reported and actigraph-recorded sleep characteristics (\*sleep quality, \*sleep efficiency, sleep latency, and duration); (1b) symptoms (\*fatigue, anxiety, depression, pain, sleepiness, sleep-related impairment), and psychomotor vigilance (PVT); and (1c) symptom clusters \[membership in clusters characterized by severity of specific symptoms; transition between clusters over time\]; (2) Test the sustained effects of CBT-I on self-reported and objective functional performance; and (3) Examine the cost-effectiveness of CBT-I. Exploratory aim: We will explore the effects of CBT-I on event-free survival.

A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6 minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost-effectiveness analysis, and survival analysis.

Eligibility criteria: Inclusion Criteria:

* stable chronic heart failure, chronic insomnia, English speaking/reading,

Exclusion Criteria:

* untreated sleep disordered breathing or restless legs syndrome, rotating/night shift work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting the non-dominant arm end-stage renal failure, significant cognitive impairment, unstable medical or psychiatric disorders

Primary outcomes:
measure: Change in Insomnia Severity
timeFrame: Baseline to 3 months
measure: Change in Fatigue
timeFrame: Baseline to 3 months
measure: Change in Sleep Efficiency-measured With PSQI
timeFrame: Baseline to 3 months
measure: Change in Sleep Quality
timeFrame: Baseline to 3 months
measure: Change in Sleep Efficiency-measured With Actigraphy
timeFrame: Baseline to 3 months
measure: Change From Baseline in Fatigue
timeFrame: Baseline to 6 months and 12 months
measure: Change From Baseline in Insomnia Severity
timeFrame: Baseline to 6 months and 12 months
measure: Change From Baseline in Sleep Quality
timeFrame: Baseline to 6 months and 12 months
measure: Change From Baseline in Sleep Efficiency Measured With PSQI (%)
timeFrame: Baseline to 6 months to 12 months
measure: Change From Baseline in Sleep Efficiency Measured With Actigraphy
timeFrame: Baseline to 6 months and 12 months
Secondary outcomes:
measure: Change in Sleep Duration
timeFrame: Baseline to 3 months
measure: Change From Baseline in Sleep Duration
timeFrame: Baseline to 6 months and 12 months
measure: Change in Anxiety Symptoms
timeFrame: Baseline to 3 months
measure: Change From Baseline in Anxiety Symptoms
timeFrame: Baseline to 6 months and 12 months
measure: Change in Depressive Symptoms
timeFrame: Baseline to 3 months
measure: Change From Baseline in Depressive Symptoms
timeFrame: Baseline to 6 months and 12 months
measure: Change in Sleepiness
timeFrame: Baseline to 3 months
measure: Change From Baseline in Sleepiness
timeFrame: Baseline to 6 months and 12 months
measure: Change in Dyspnea
timeFrame: Baseline to 3 months
measure: Change From Baseline in Dyspnea
timeFrame: Baseline to 6 months and 12 months
measure: Change in Psychomotor Vigilance
timeFrame: Baseline to 3 months
measure: Change From Baseline in Psychomotor Vigilance
timeFrame: Baseline to 6 months and 12 months
measure: Change in Functional Performance
timeFrame: Baseline to 3 months
measure: Change From Baseline in Functional Performance
timeFrame: Baseline to 6 months and 12 months
measure: Change in Distance (Feet) Traveled During Six Minute Walk Test
timeFrame: Baseline to 3 months
measure: Change in Distance (Feet) Traveled During Six Minute Walk Test
timeFrame: Baseline to 6 months and 12 months
measure: Cost Effectiveness
timeFrame: 12 months post treatment
measure: Change From Baseline in Sleep Latency (Minutes)
timeFrame: Baseline to 6 months and 12 months
measure: Change in Sleep Latency
timeFrame: Baseline to 3 months
measure: Change in Sleep Related Impairment
timeFrame: Baseline to 3 months
measure: Change From Baseline in Sleep Related Impairment
timeFrame: Baseline to 6 months and 12 months
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Yale University School of Nursing
state: Connecticut
Study officials:
affiliation: Yale University School of Nursing
name: Nancy S Redeker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'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.
citation: Breazeale 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.
citation: Redeker 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.
citation: Redeker 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.