Back to search results

Study on Insomnia Treatment and Weight Loss for Breast Cancer Survivors

This study is looking at how treating insomnia might help breast cancer survivors lose weight. It's for women who have had early-stage breast cancer, are overweight or obese, and also have insomnia. You would either receive Cognitive-Behavioral Therapy for Insomnia (CBT-I), which is a program to help you sleep better, or Sleep Education Control, which involves reading about sleep. Both groups will then participate in a behavioral weight loss program. Researchers want to see if CBT-I before weight loss helps more with losing weight. The study aims to enroll 250 women. The study status is currently unclear.

Study design
This is a randomized controlled clinical trial, meaning participants are randomly assigned to one of two groups. It plans to enroll 250 women.
What's involved
The study lasts 14 months and includes one video screening visit, four in-person assessment visits, and 27 video sessions. These sessions cover sleep intervention/control and behavioral weight loss.
Compensation
Not stated in the trial record.
Follow-up
Your weight will be measured at baseline, 8 weeks after the sleep intervention, and then at 3, 6, and 12 months after the behavioral weight loss program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05780814

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

Recruiting
NAAges 18+InterventionalTreatment
Johns Hopkins University
~250 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:Cognitive-Behavioral Therapy for Insomnia (CBT-I)Sleep Education Control (EDU)

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Weight (pounds)
Measured over Baseline (randomization); 8 weeks post-sleep intervention (prior to BWL); and at 3, 6, and 12 months post-BWL.

Conditions

Breast Cancer
Insomnia
Weight Gain

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In Situ

Where it's being run

4 sites across 2 states
Maryland3
District of Columbia1

Study leadership

  • Janelle Wilder Coughlin, PHD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
  • Michael Smith, PHD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Janelle Wilder Coughlin, PHD
[email protected]
(410) 550-7000
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Female
18 years of age or older
Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasive carcinoma of the breast
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Current BMI ≥ 25 kg/m2 and weight ≤ 400 lbs
Willing to lose 10% of body weight
Diagnosed within 10 years with histologically-confirmed DCIS or stage I-III invasive carcinoma of the breast
Completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy/immunotherapy(/HER2) human epidermal growth factor receptor 2 therapy/targeted therapy at least 3months prior to enrollment (concomitant endocrine therapy allowed)
Completed all planned/elective surgeries \>4 weeks before enrollment
Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for Insomnia disorder
Self-reported initial sleep onset time and/or wake after sleep onset (WASO) time \> 30 minutes, \> 3 nights/week
Reports sleep problems present for ≥ 3 months
Insomnia Severity Index Score ≥ 9

Exclusion

Serious/uncontrolled medical or psychiatric condition likely to hinder participation in BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmune disease, etc.)
Current use of medications that cause sleep disturbances or weight gain/loss. (-) Current sedative hypnotic use
Sleep disorder other than insomnia (mild sleep apnea or moderate to severe sleep apnea successfully treated via positive airway pressure (PAP) therapy is permitted
Currently enrolled or planning to enroll in a sleep treatment or weight loss program (agree not to enroll for the duration of the study) (-) Home sleep test Apnea/hypopnea Index (AHI) \> 15
Participants also agree not to enroll in such a program for the duration of study participation (regardless of randomization).
History of unstable psychiatric disorder
Self-reported suicidal ideation or severe depressive symptoms as determined by clinical assessment, triggered by score of ≥ 20 on the Center for Epidemiologic Studies Depression (CES-D)
Lactating, pregnant or plan to become pregnant in next 14 months
Positive urine toxicology for recreational drugs of abuse; alcohol or substance use disorder as determined by Alcohol Use Disorders Identification Test, Adapted for Use in the United States (USAUDIT294) and/or Structured Clinical Interview (SCID)
Daily smoker/nicotine user
Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the patient's full compliance with or completion of the study

What this trial measures

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

    Our primary endpoint is % total weight loss (TWL) at 12 months. We will measure weight in light clothes without shoes, using a digital scale (in pounds) and height to the nearest 0.1 cm using a calibrated stadiometer, according to standardized procedures.