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The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer
Sponsor: Johns Hopkins University
Summary
The investigators propose a randomized controlled clinical trial in 250 women with a history of early stage breast cancer who are overweight or obese with insomnia to test whether a brief, cognitive-behavioral intervention for insomnia (CBT-I) prior to behavioral weight loss (CBT-I+BWL) is superior to a sleep education control (EDU) condition followed by behavioral weight loss (EDU+BWL). The investigators will measure outcomes at baseline, 8 weeks (after completing CBT-I or EDU and prior to BWL), and at 3, 6, and 12 months.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-02-01
Completion Date
2028-12-31
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
The CBT-I intervention is a 6-session intervention spread out over 8 weeks that combines education and behavioral techniques to reduce insomnia.
Sleep Education Control (EDU)
Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine
Locations (4)
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins
Baltimore, Maryland, United States
Johns Hopkins Bayview
Baltimore, Maryland, United States
Johns Hopkins Kimmel Cancer Center at Greenspring Station
Lutherville, Maryland, United States