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~167 spots leftby Dec 2028

CBT for Insomnia in Breast Cancer Survivors
(COIN Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byMichael Smith, PHD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Must not be taking: Sedative hypnotics

Disqualifiers: Bipolar, Psychotic, Seizure, Autoimmune, others

Trial Summary

What is the purpose of 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 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that cause sleep disturbances or weight changes. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Insomnia (CBT-I) in breast cancer survivors?

Research shows that Cognitive-Behavioral Therapy for Insomnia (CBT-I) is effective in reducing insomnia symptoms in breast cancer survivors, improving their sleep, quality of life, and mood. Internet-delivered CBT-I (iCBT-I) has also been shown to be effective in this group, making it more accessible for those who cannot attend in-person sessions.¹ ² ³ ⁴ ⁵

Is cognitive-behavioral therapy for insomnia (CBT-I) safe for humans?

Cognitive-behavioral therapy for insomnia (CBT-I) is generally considered safe for humans, including cancer survivors. It is a non-drug treatment that focuses on changing sleep-related thoughts and behaviors, and studies have shown it can improve sleep and quality of life without significant safety concerns.² ³ ⁴ ⁶ ⁷

How is the treatment CBT-I for insomnia in breast cancer survivors different from other treatments?

CBT-I (Cognitive-Behavioral Therapy for Insomnia) is unique because it is a non-drug treatment that focuses on changing sleep habits and behaviors, and it can be delivered over the internet, making it more accessible for breast cancer survivors who may have difficulty accessing traditional therapy sessions.² ³ ⁴ ⁸ ⁹

Research Team

Janelle Wilder Coughlin, PHD

Principal Investigator

Johns Hopkins University

Michael Smith, PHD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for overweight or obese female breast cancer survivors, aged 18+, who have insomnia. They must be willing to lose weight and have completed cancer treatments at least 3 months prior. Exclusions include other sleep disorders (except mild apnea), drug abuse, current smokers, or those with unstable psychiatric conditions.

Inclusion Criteria

I was diagnosed with early-stage breast cancer or DCIS within the last 10 years.

You have trouble falling asleep or staying asleep for more than 30 minutes on most nights.

You have a score of 9 or more on a test that measures how bad your insomnia is.

See 10 more

Exclusion Criteria

I am not planning to join any sleep or weight loss programs and my sleep test shows moderate to severe issues.

I do not have any serious health or mental conditions that could interfere with treatment.

I have a sleep disorder other than insomnia, but if it's sleep apnea, it's under control with PAP therapy.

See 8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 video visit

Sleep Intervention

Participants undergo a cognitive-behavioral intervention for insomnia (CBT-I) or a sleep education control (EDU) over 8 weeks

8 weeks

6 video sessions

Behavioral Weight Loss (BWL)

Participants engage in a behavioral weight loss program using social cognitive theory and motivational interviewing

12 months

19 video sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 in-person assessment visits

Treatment Details

Interventions

Cognitive-Behavioral Therapy for Insomnia (CBT-I) (Behavioural Intervention)
Sleep Education Control (EDU) (Behavioural Intervention)

Trial OverviewThe study tests if Cognitive-Behavioral Therapy for Insomnia (CBT-I) enhances the effectiveness of a subsequent behavioral weight loss program compared to just receiving sleep education followed by the same weight loss program in women who've had early stage breast cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Cognitive-Behavioral Therapy for Insomnia (CBT-I)Experimental Treatment1 Intervention

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.

Group II: Sleep Education Control (EDU)Placebo Group1 Intervention

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

This study aims to evaluate the effectiveness of Brief Behavioral Therapy for Insomnia (BBTI) in reducing insomnia among 158 cancer survivors, marking the first time this approach is tested in such a diverse group.

The primary outcome will be assessed using the Insomnia Severity Index (ISI), with follow-up assessments planned at 1, 3, and 12 months to determine the durability of the intervention's effects on sleep quality and overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A nurse-delivered intervention to reduce insomnia in cancer survivors: Study protocol for a randomized-controlled trial.Kwon, M., Dickerson, SS., Wilding, GE., et al.[2023]

A pilot study involving 38 cancer survivors showed that a brief, group-based cognitive-behavioral therapy for insomnia (CBT-Insomnia) program significantly improved sleep efficiency, quality, and insomnia symptoms after just three sessions over one month.

Despite experiencing insomnia symptoms for an average of 2.4 years, many survivors had not discussed their sleep issues with healthcare providers, highlighting the need for increased awareness and access to insomnia treatments in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program.Zhou, ES., Partridge, AH., Recklitis, CJ.[2022]

Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to significantly improve sleep quality and psychological outcomes in cancer patients and survivors, based on a review of 12 studies.

CBT-I not only enhances sleep but may also positively affect mood, fatigue, and overall quality of life, and it can be delivered through various methods to reach more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients.Garland, SN., Johnson, JA., Savard, J., et al.[2022]