Clinical trial NCT02827799: Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure
Official title: Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Insomnia
Cardiomyopathy
Keywords: heart failure
insomnia
sleep disorders
actigraphy
cardiomyopathy
depression
sleepiness
anxiety
fatigue
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-07-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Participants were randomized either to a treatment (CBT-I) or attention-control condition (heart failure self management education).

Detailed description: Insomnia is common in adults with chronic heart failure (HF), a condition associated with functional performance deficits, symptom burden, and high levels of morbidity and mortality. To date there has been little study of strategies to improve sleep in this large population. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia comorbid with several medical and psychiatric disorders, but has not been tested in HF. The purpose of this exploratory developmental research is to test the feasibility, acceptability, and size of the effects of CBT-I on subjective and objective characteristics of sleep and insomnia symptoms and functional performance in patients with stable HF. Forty patients with stable HF will be randomized to 7 weeks of CBT-I or 7-weeks of HF self-management education with sleep hygiene (attention control). Subjective (diaries, questionnaires) and objective (wrist actigraphy) characteristics of sleep; symptoms, and self-reported functional performance will be measured pre- and post-intervention. The investigators will also obtain day and night measures of urinary free cortisol, free epinephrine/norepinephrine, and melatonin sulfate. They will: 1) refine the protocol, procedures, patient materials, and training manual for the CBT-I intervention and a group HF self-management class (attention-control); 2) evaluate the feasibility and acceptability of the CBT-I intervention and the attention-control conditions; 3) evaluate the size of the effects of group CBT-I, compared with attention-control, on objective (actigraph) and subjective (questionnaire and sleep diary) sleep characteristics, self-report of insomnia symptoms, and beliefs and attitudes about sleep; and 4) evaluate the size of the effects of CBT-I, compared with attention-control, on daytime symptoms (fatigue, depression, anxiety, excessive daytime sleepiness) and functional performance. The primary outcome will be self-reported sleep continuity (sleep efficiency). Investigators will also explore the effects of changes in characteristics of sleep and insomnia symptoms on symptoms and daytime function; the effects of CBT-I, compared with attention control, on nocturnal symptoms, and the effects of CBT-I, compared with attention control, on biological indicators of nocturnal and daytime Hypothalamic Adrenal Pituitary axis (urinary free cortisol), sympathetic nervous system (urinary epinephrine/norepinephrine, and pineal (urinary melatonin) function. The results will be used to support design decisions for a future larger scale efficacy study and may ultimately lead to translation of CBT-I into the care of patients with HF.

Eligibility criteria: Inclusion Criteria:

* Stable chronic heart failure
* reports of difficulty initiating or maintaining sleep or waking too early in the morning
* 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: Insomnia severity
timeFrame: baseline two weeks after completing treatment or attention/control
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline and two weeks after completing treatment or attention control
measure: Sleepiness
timeFrame: Baseline and two weeks after completing treatment or attention control
measure: Anxiety
timeFrame: Baseline and two weeks after completing treatment or attention-control
measure: Fatigue
timeFrame: baseline and two weeks after completing treatment or attention-control
measure: Sleep efficiency
timeFrame: baseline and two weeks after completing treatment or attention control
measure: Functional Performance
timeFrame: baseline and two weeks after completing treatment or attention control
measure: Thoughts and beliefs about sleep
timeFrame: Baseline and two weeks after completing treatment or attention control.
measure: Cortisol
timeFrame: baseline and two weeks after completing treatment or attention control.
measure: Melatonin
timeFrame: baseline and two weeks after completing treatment or attention control.
measure: Epinephrine
timeFrame: baseline and two weeks after completing treatment or attention control.
measure: Norepinephrine
timeFrame: baseline and two weeks after completing treatment or attention control.
measure: Nocturnal symptoms
timeFrame: baseline and two weeks after completing treatment or attention control
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, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redeker NS, Jeon S, Andrews L, Cline J, Jacoby D, Mohsenin V. Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure. J Clin Sleep Med. 2015 Oct 15;11(10):1109-19. doi: 10.5664/jcsm.5082.
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, Jeon S, Andrews L, Cline J, Mohsenin V, Jacoby D. Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure. Behav Sleep Med. 2019 May-Jun;17(3):342-354. doi: 10.1080/15402002.2017.1357120. Epub 2017 Aug 22.