Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors

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

Recruiting N/A Interventional Study
Breast Cancer Insomnia Weight Gain
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for

This trial is looking for women who have survived early stage breast cancer, are overweight, and have insomnia. Participants will receive either a mental health program to improve sleep or sleep education, followed by a program to help with weight loss.

Are You a Good Fit for This Trial?
Must not be taking Sedative hypnotics
Rules you out Bipolar disorderPsychotic disorderSeizure disordersAutoimmune disease

You may be able to join if

  • I am female.
  • I am 18 years of age or older.
  • I have been diagnosed with early stage breast cancer.
  • I am overweight or obese.
  • I have insomnia.
  • I am willing to lose 10% of my body weight.
  • I completed my local therapy at least 3 months before joining.
  • I have sleep problems that have lasted for at least 3 months.

You may not be able to join if

  • I have a serious medical or psychiatric condition.
  • I am currently taking medications that disturb sleep.
  • I have a sleep disorder other than insomnia.
  • I am enrolled in another sleep treatment or weight loss program.
  • I have a history of unstable psychiatric disorder.
  • I have suicidal thoughts or severe depression.
  • I am pregnant or planning to become pregnant within the next 14 months.
  • I am a daily smoker.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 inves…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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% o…
Contacts

Janelle Wilder Coughlin, PHD

(410) 550-7000

jwilder3@jhmi.edu

CONTACT

Katie Smith, BA

(410) 550-8099

ksmit261@jhmi.edu

CONTACT