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: Unknown

5 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting. Secondary objectives: 1. To compare insomnia symptoms before and after intervention. 2. To evaluate any changes in quality of life symptoms while undergoing the intervention. 3. To evaluate the duration of symptoms improvement after the intervention is complete.

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 data supports the idea that Online Group CBT-I for Insomnia in Cancer Patients is an effective treatment?

The available research shows that Online Group CBT-I is effective for treating insomnia in cancer patients. Studies indicate that it leads to significant improvements in sleep quality and can also enhance mood, reduce fatigue, and improve overall quality of life. This treatment can be delivered in various ways, making it accessible to more patients compared to traditional methods. Additionally, a study comparing digital CBT-I to sleep hygiene education found it to be more effective for managing insomnia in women with cancer. ^{1 2 3 4 5}

What safety data exists for online CBT-I for insomnia in cancer patients?

The studies reviewed indicate that online CBT-I, including eHealth and internet-delivered versions, is generally safe and feasible for cancer patients, particularly breast cancer survivors. The pilot randomized controlled trial for Spanish-speaking breast cancer survivors showed high recruitment and retention rates, with participants attending most sessions and reporting acceptable satisfaction levels. The systematic review of CBT-I in cancer patients suggests that it leads to significant improvements in sleep and psychological outcomes, with no major safety concerns reported. Overall, online CBT-I appears to be a safe and effective non-pharmacological treatment for insomnia in cancer patients. ^{2 4 5 6 7}

Is the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) promising for cancer patients with insomnia?

Yes, Cognitive Behavioral Therapy for Insomnia (CBT-I) is a promising treatment for cancer patients with insomnia. Studies show that it can effectively improve sleep quality, reduce insomnia symptoms, and enhance overall quality of life for cancer survivors. It is especially beneficial because it can be delivered online, making it accessible to more patients. ^{1 5 6 7 8}

Research Team

Hui Chen, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

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

I am a woman over 18, speak English, and am seeing treatment or check-ups for gynecologic cancer at UC Davis.

Be able to connect via secure web-based platform

Be able to complete online questionnaires

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for insomnia in cancer patients: a systematic review and network meta-analysis. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients. [2022]

3. Germany 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. [2021]

4. United States 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. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Guided web-based intervention for insomnia targeting breast cancer patients: Feasibility and effect. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive-Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Randomized Controlled Trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in Breast Cancer Survivors: A Review of the Literature. [2020]