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

NCT05780814 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Janelle Wilder Coughlin, PHD · Johns Hopkins University

  • Michael Smith, PHD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780814 on ClinicalTrials.gov