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RECRUITING
NCT05780814
NA

The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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