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Cancer, Obesity/Overweight and Insomnia Study

NCT03542604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-16

No results posted yet for this study

Summary

This is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. This study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

CBT-I involves identifying and replacing thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. There will be 6 intervention sessions over an 8-week period. The first two sessions are consecutive weekly in-person sessions followed by a rest week. The third session is conducted remotely by phone, followed by another rest week. The three remaining sessions are weekly and conducted remotely.

BEHAVIORAL

Sleep Education

EDU involves learning behavioral treatment information about sleep that is widely available to patients and practitioners. The program will parallel the CBT-I intervention in schedule, number, and length of sessions.

Sponsors & Collaborators

  • Under Armour, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Janelle Coughlin, Ph.D. · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03542604 on ClinicalTrials.gov