Recruiting

Insomnia Treatment

Sponsor:

Johns Hopkins University

Code:

NCT05780814

Conditions

Breast Cancer

Insomnia

Weight Gain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

Sleep Education Control (EDU)

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Insomnia

Weight Gain

Study ID

NCT05780814

Start date

Feb 1, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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% 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 Criteria:

  • 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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cognitive-Behavioral Therapy for Insomnia (CBT-I)

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)

Subjects will be instructed to read and review select publications from the American Academy of Sleep Medicine

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 and Locations

Central contacts

Janelle Wilder Coughlin, PHD

(410) 550-7000jwilder3@jhmi.edu

Katie Smith, BA

(410) 550-8099ksmit261@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Katie Smith, BA

410-550-8099ksmit261@jhmi.edu

Principal Investigator:

Janelle Wilder Coughlin, PHD

Sidney Kimmel Comprehensive Cancer Center, the Avon Foundation Breast Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Katie Smith, BA

410-550-8099ksmit261@jhmi.edu

Principal Investigator:

Janelle Wilder Coughlin, PHD

Johns Hopkins Bayview

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Katie Smith, BA

410-550-8099ksmit261@jhmi.edu

Principal Investigator:

Janelle Wilder Coughlin, PHD

Johns Hopkins Kimmel Cancer Center at Greenspring Station

Recruiting

Lutherville, Maryland, United States, 21093

Contacts

Katie Smith, BA

410-550-8099ksmit261@jhmi.edu

Principal Investigator:

Janelle Wilder Coughlin, PHD

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • women
  • breast cancer
  • weight gain
  • weight loss
  • insomnia
  • sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-23.