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

Inclusion Criteria:

• Female

• 18 years of age or older

• Histologically-confirmed Ductal Carcinoma In Situ (DCIS) or stage I-III invasivecarcinoma 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 invasivecarcinoma of the breast

• Completed local therapy (i.e. surgery and radiation therapy) and any plannedpreoperative or adjuvant chemotherapy/immunotherapy(/HER2) human epidermal growthfactor 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 forInsomnia 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 Criteria:

• Serious/uncontrolled medical or psychiatric condition likely to hinder participationin BWL or CBT-l (bipolar disorder, psychotic disorder, seizure disorders, autoimmunedisease, 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 sleepapnea 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 testApnea/hypopnea Index (AHI) > 15

• Participants also agree not to enroll in such a program for the duration of studyparticipation (regardless of randomization).

• History of unstable psychiatric disorder

• Self-reported suicidal ideation or severe depressive symptoms as determined byclinical assessment, triggered by score of ≥ 20 on the Center for EpidemiologicStudies 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 usedisorder as determined by Alcohol Use Disorders Identification Test, Adapted for Usein 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 atincreased risk or preclude the patient's full compliance with or completion of thestudy