Insomnia Self-Management in Heart Failure
CompletedNot applicableNCT02660385
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
- 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
- Interventions
- Behavioral: Cognitive Behavioral Therapy for Insomnia
- Behavioral: Self-Management Education for Heart Failure
- Sponsor
- Yale University
- Collaborators
- Milton S. Hershey Medical Center; National Institute of Nursing Research (NINR)
- Start date
- 2016-03-07
- Primary completion
- 2020-08-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02660385