Insomnia Self-Management in Heart Failure

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.

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

This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.

BEHAVIORAL

Self-Management Education for Heart Failure

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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Nancy S Redeker, PhD · Yale University School of Nursing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-07

Primary Completion

2020-08-01

Completion

2021-11-30

Countries

• United States

Study Locations