Online Group CBT-I for Insomnia in Cancer Patients

Overseen By UC Davis Comprehensive Cancer Center

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Sleep medications

Disqualifiers: Poor sleep, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online group therapy called Cognitive Behavioral Therapy for Insomnia (CBT-I) to assist women with gynecologic cancer who struggle with sleep. The research focuses on evaluating the effectiveness and user-friendliness of this online therapy. It also examines changes in insomnia symptoms and quality of life after the therapy. Women with moderate to severe insomnia, undergoing treatment for gynecologic cancer, and with internet access might be suitable for this study. Participants will attend weekly online sessions for six weeks and provide feedback on their experience. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep and quality of life for women with gynecologic cancer.

Do I have to stop taking my current medications for the trial?

If you are currently taking prescribed sleep medication for insomnia, you cannot participate in the trial. However, if you are taking over-the-counter medications or supplements, you are eligible.

What prior data suggests that this method is safe for cancer patients?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is safe and well-tolerated, particularly for cancer survivors. In past studies, most participants did not experience major side effects. For example, one study found that online CBT-I with clinician support improved sleep without causing significant problems. Another study demonstrated that group CBT-I via telehealth was safe and effective for individuals with brain tumors, suggesting its general safety across different groups.

CBT-I improves sleep habits and reduces stress related to insomnia without using medication, often resulting in fewer side effects. This makes it a suitable choice for those seeking to manage insomnia safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Online Group Cognitive Behavioral Therapy for Insomnia (CBT-I) because it offers a fresh approach to managing insomnia in cancer patients. Unlike traditional face-to-face therapy sessions, this treatment is delivered online, making it more accessible and convenient for patients who may be dealing with treatment fatigue or have mobility issues. Additionally, the small-group setting provides peer support, which can enhance motivation and engagement, potentially leading to better outcomes compared to individual therapy. This method could redefine how insomnia is managed in cancer patients, offering a more flexible and supportive option.

What evidence suggests that this online group CBT-I is effective for insomnia in cancer patients?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) can help cancer patients with sleep problems. Studies indicate that online CBT-I with clinician support can greatly improve sleep issues in cancer survivors. In one study, breast cancer survivors using a voice-activated CBT-I program reported better sleep. Another study found that CBT-I reduced fatigue by improving sleep. This trial will evaluate the effectiveness of an online group CBT-I program, with participants meeting weekly for six weeks. Overall, CBT-I is considered an effective treatment for improving sleep in cancer patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Hui Chen, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

This trial is for English-speaking women over 18 with moderate or severe insomnia who are being treated or monitored for gynecologic cancer at UC Davis Comprehensive Cancer Center. They must have internet access, be able to use a secure web platform and complete online questionnaires using a mobile device or computer.

Inclusion Criteria

Be able to connect via secure web-based platform

Be able to complete online questionnaires

Have access to a mobile device or computer

Exclusion Criteria

I cannot use web platforms that require audio and video.

You have other reasons that may cause poor sleep.

I am taking prescription sleep medication for insomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive internet-delivered group cognitive behavioral therapy for insomnia over 6 weeks

6 weeks

6 weekly online sessions

Follow-up

Participants are monitored for changes in insomnia symptoms and quality of life after the intervention

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview The study tests the effectiveness of delivering cognitive behavioral therapy for insomnia (CBT-I) via the internet in small groups to these patients. It will assess changes in their sleep quality and overall life quality before and after treatment, as well as how long improvements last.

How Is the Trial Designed?

Group I: CBT-I online group Experimental Treatment 1 Intervention

Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program. At the end of each weekly session, participants will complete a survey reviewing the acceptability of undergoing insomnia treatment in an internet-based small-group setting.

Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Approved in United States as Somryst for:

• Chronic Insomnia

Approved in United Kingdom as Sleepio for:

• Insomnia

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

A pilot study involving 30 Spanish-speaking breast cancer survivors showed that a 6-week eHealth Cognitive-Behavioral Therapy for Insomnia (CBT-I) intervention was highly acceptable and feasible, with excellent recruitment (95%) and retention (97%).

Post-treatment results indicated that CBT-I significantly improved insomnia symptoms, sleep disturbance, and sleep efficiency, with medium to large effect sizes, demonstrating its preliminary efficacy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. Oswald, LB., Morales-Cruz, J., Eisel, SL., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly reduces insomnia severity, sleep onset latency, and wake after sleep onset in cancer patients, while improving sleep efficiency, based on a meta-analysis of 16 trials with 1523 participants.

Group CBT-I is the most effective delivery format, showing sustained improvements in sleep efficiency and total sleep time at short-term follow-up, although the benefits diminish over time, highlighting the need for further high-quality studies to confirm long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for insomnia in cancer patients: a systematic review and network meta-analysis. Gao, Y., Liu, M., Yao, L., et al.[2022]

Internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I) significantly improved sleep outcomes in 255 breast cancer survivors with clinically significant sleep disturbances, showing a strong effect on insomnia severity (Cohen's d = 1.17).

The benefits of iCBT-I were not only immediate but also sustained at follow-up, indicating its potential as a low-cost and effective treatment option that could be integrated into cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. Zachariae, R., Amidi, A., Damholdt, MF., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective treatment for insomnia in breast cancer survivors, significantly improving sleep quality, mood, and overall quality of life based on a review of 16 studies.

The benefits of CBT-I, including reductions in fatigue and menopausal symptoms, are durable, lasting up to 12 months after treatment, highlighting its potential as a long-term solution for insomnia in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. Aricò, D., Raggi, A., Ferri, R.[2020]

The study aims to evaluate the effectiveness of digital cognitive behavioral therapy for insomnia (dCBT-I) compared to sleep hygiene education (SHE) in 308 women with cancer experiencing insomnia, with assessments at 12 and 24 weeks.

The primary outcome will measure changes in sleep quality using the Sleep Condition Indicator (SCI) score, helping to determine if dCBT-I provides better management of insomnia than SHE in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sleepio after cancer (SAC) study. Digital cognitive behavioural therapy for insomnia (dCBT-I) in women cancer patients - Trial protocol of a randomised controlled trial. Treacy, T., O'Meara, Y., Galligan, MC., et al.[2023]

In a study involving 173 cancer outpatients, 57% reported significant insomnia symptoms, and 80% of those willing to participate found the video-based cognitive behavioral therapy for insomnia (VCBT-I) acceptable, indicating a strong demand for this intervention.

Participants experienced increased knowledge about sleep and improved sleep quality after using VCBT-I, although technical and contextual barriers were noted, suggesting that remote professional support could enhance the effectiveness and personalization of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a video-based cognitive behavioral therapy for insomnia in French adult cancer outpatients: results from the Sleep-4-All-1 study. Boinon, D., Charles, C., Fasse, L., et al.[2021]

The Internet-based cognitive behavioral therapy (I-CBT) intervention, I-Sleep, was found to be feasible and well-accepted among breast cancer patients, with a completion rate of 59% and a satisfaction score of 7.5 out of 10.

Participants experienced significant improvements in insomnia severity (effect size d = 1.33), fatigue, and daytime functioning, particularly benefiting younger patients and those with more severe insomnia at the start of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided web-based intervention for insomnia targeting breast cancer patients: Feasibility and effect. Dozeman, E., Verdonck-de Leeuw, IM., Savard, J., et al.[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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32840955/

Video cognitive-behavioral therapy for insomnia in cancer ... Although CBT-I is slightly less efficacious when self-administered, it constitutes a much more cost-effective alternative than face-to-face CBT-I.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725000723

Web-based cognitive-behavioral therapy for insomnia in ... Web-based CBT-I with clinician support appears to be an effective treatment for insomnia in cancer survivors, offering meaningful benefits for comorbid symptoms ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823907

Voice-Activated Cognitive Behavioral Therapy for Insomnia This randomized clinical trial of an in-home, voice-activated CBT-I program among breast cancer survivors found that the intervention improved insomnia ...

4. academic.oup.com academic.oup.com/sleep/article/48/6/zsaf014/7960093

Impact and mechanisms of cognitive behavioral therapy for ... CBT-I resulted in significant improvement in fatigue, and these effects were largely accounted for by changes in insomnia. CBT-I is a robust intervention with ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e13555

Improving sleep outcomes in patients with cancer ... The objective of this study is to assess the efficacy of CBT-i for chronic insomnia among cancer patients. Methods: A retrospective review of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11423177/

Voice-Activated Cognitive Behavioral Therapy for Insomnia This randomized clinical trial investigates whether in-home delivery of a daily voice-activated cognitive behavioral therapy program improves insomnia symptoms

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37796017/

Telehealth group Cognitive-Behavioral Therapy for Insomnia ... Results of this proof-of-concept trial indicate that telehealth group CBT-I is feasible, safe, and acceptable among PwPBT, providing support for future ...

8. sleep.biomedcentral.com sleep.biomedcentral.com/articles/10.1186/s41606-025-00129-8

Recording and reporting of adverse events during a ... CBT-I is a safe treatment that is well-tolerated by cancer survivors. The majority of participants did not experience AEs that could be ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02756390

CBTI-CS: A Novel Cognitive-Behavioral Treatment for ... This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention ...