Insomnia Self-Management in Heart Failure
Public ClinicalTrials.gov record NCT02660385. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Cognitive Behavioral Therapy for Insomnia: A Self-Management Strategy for Chronic Illness in Heart Failure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02660385
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 195 participants
Conditions and interventions
Conditions
Interventions
- Cognitive Behavioral Therapy for Insomnia Behavioral
- Self-Management Education for Heart Failure Behavioral
Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 6, 2016
- Primary completion
- Jul 31, 2020
- Completion
- Nov 29, 2021
- Last update posted
- Feb 8, 2023
2016 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale University School of Nursing | West Haven | Connecticut | 06516-7399 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02660385, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 8, 2023 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02660385 live on ClinicalTrials.gov.