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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT05780814
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive-Behavioral Therapy for Insomnia (CBT-I) — BEHAVIORAL
    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) — BEHAVIORAL
    Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

Study Details

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 Dates

Start date
Feb 1, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
    The proposed intervention consists of 6 remotely-delivered sessions; Weeks 1, 2, 4, 6, 7, and 8, with weeks 3 and 5 being "rest weeks". Session 1 will be 60-90 mins, Session 2 will be \~60 mins, and remaining visits are \~45 mins. The investigators propose a methodological innovation for CBT-I, which involves conducting 15-minute sessions every other month during the BWL intervention. Prior to these maintenance sessions, participants in the CBT-I+BWL group will complete electronic sleep diaries for one week and interventionists will use this information in sessions to sustain and enhance long-term outcomes by using MI to reinforce application of CBT-I session content.
  • Placebo Comparator: Sleep Education Control (EDU)
    The EDU intervention will parallel the CBT-I intervention in number, format and length of all sessions, including maintenance sessions. It provides basic information about sleep and cancer, widely available to the public. EDU content does not include any individualized behavioral instructions, sleep diary monitoring during the intervention, or behavior change counseling. Content is presented didactically only.

Primary Outcome Measure

Change in Weight (pounds) [ Time Frame: Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Katie Smith, BA
[email protected]
410-550-8099
Janelle Wilder Coughlin, PHD (PRINCIPAL_INVESTIGATOR)
Michael Smith, PHD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins BayviewBaltimoreMaryland21224
Katie Smith, BA
[email protected]
410-550-8099
Janelle Wilder Coughlin, PHD (PRINCIPAL_INVESTIGATOR)
Michael Smith, PHD (PRINCIPAL_INVESTIGATOR)
Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns HopkinsBaltimoreMaryland21218
Katie Smith, BA
[email protected]
410-550-8099
Janelle Wilder Coughlin, PHD (PRINCIPAL_INVESTIGATOR)
Michael Smith, PHD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Kimmel Cancer Center at Greenspring StationLuthervilleMaryland21093
Katie Smith, BA
[email protected]
410-550-8099
Janelle Wilder Coughlin, PHD (PRINCIPAL_INVESTIGATOR)
Michael Smith, PHD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
Breast cancerInsomnia
By specialty
OncologyBreast oncologyWomen's healthMental healthSleep medicine
By research site
Sibley Memorial Hospital· Washington D.C., DCJohns Hopkins Bayview· Baltimore, MDSidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins· Baltimore, MDJohns Hopkins Kimmel Cancer Center at Greenspring Station· Lutherville, MD

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