CBT-I for Insomnia in Cancer Patients

Overseen By Josée Savard, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Disqualifiers: Major depressive disorder, Parkinson's, dementia, 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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help cancer patients who struggle with insomnia, a common issue that can become chronic and lead to other problems. The study uses a program that begins with web-based cognitive-behavioral therapy for insomnia (CBT-I) and, if needed, adds sessions with a therapist. This approach is designed to be more cost-effective and accessible than traditional face-to-face therapy. The trial seeks participants diagnosed with non-metastatic cancer who have ongoing insomnia and internet access. As an unphased trial, it offers patients the opportunity to access innovative therapy methods that could improve their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this stepped care CBT-I is safe for cancer patients?

Research has shown that online cognitive-behavioral therapy for insomnia (CBT-I) is generally safe for cancer patients. Studies have found that this online method can improve sleep and reduce tiredness without causing major side effects. These digital treatments have proven effective for various cancer patients, offering real benefits for those struggling with insomnia.

Additionally, in-person CBT-I has been well-researched and matches the effectiveness of some sleep medications for short-term insomnia. It is considered a safe and proven treatment option. Overall, both online and in-person CBT-I are well-tolerated by patients, making them a promising choice for managing insomnia in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about web-based cognitive-behavioral therapy for insomnia (CBT-I) because it offers a convenient, accessible way for cancer patients to manage sleep issues without needing in-person sessions. Unlike traditional treatments that might require medications or face-to-face therapy, this web-based approach allows patients to receive care from the comfort of their home, potentially increasing adherence and participation. This method not only reduces the barriers to receiving effective insomnia treatment but also empowers patients to engage actively in their own care, making it a promising option for those dealing with the additional challenges of cancer.

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

Research has shown that online cognitive-behavioral therapy for insomnia (CBT-I), a treatment option in this trial, helps cancer patients sleep better. Studies have found that this method can reduce insomnia severity and improve fatigue and mood. Specifically, online CBT-I with some therapist support has successfully provided significant relief for insomnia and related symptoms in cancer survivors. This approach often costs less than traditional in-person therapy while offering similar benefits. Overall, evidence strongly supports using online CBT-I as an effective treatment for insomnia in cancer patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Josée Savard, Ph.D.

Principal Investigator

Centre de recherche du CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-metastatic cancer who can read and understand French or English, have basic cognitive abilities, and internet access. It's not suitable for those with severe psychological issues like major depression, significant cognitive impairments such as dementia, or insomnia caused by temporary conditions.

Inclusion Criteria

I have been diagnosed with cancer that has not spread.

You need to have an Internet connection.

Having access to Internet

Exclusion Criteria

You have a serious problem with memory or thinking, like Parkinson's disease or dementia.

You have a mental health condition that requires ongoing care, like major depression.

I have insomnia because of a temporary situation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Passive Phase

Comparison of effects during a passive phase before active intervention

4 months

Active Phase

Implementation of stepped care CBT-I in cancer clinics using a non-randomized stepped wedge design

20 months

Follow-up

Participants are monitored for changes in insomnia severity and other outcomes post-treatment

6-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Professionally-administered booster face-to-face CBT-I sessions
• Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Trial Overview The study tests a stepped care approach to treating insomnia in cancer patients using web-based CBT-I (Insomnet) followed by up to three professional therapy sessions if needed. The effectiveness of this method will be compared against usual care in a real-world setting across four hospitals.

How Is the Trial Designed?

Group I: Stepped care CBT-I Experimental Treatment 2 Interventions

Web-based cognitive-behavioral therapy for insomnia (CBT-I) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CBT-I for:

• Insomnia in cancer patients

Approved in European Union as CBT-I for:

• Insomnia in cancer patients

Approved in Canada as CBT-I for:

• Insomnia in cancer patients

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Canadian Cancer Society (CCS)

Collaborator

Trials

84

Recruited

42,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

A study involving 75 participants with insomnia disorder showed that an interactive online cognitive behavioral therapy (CBT-i) significantly improved sleep efficiency and sleep latency, indicating its efficacy as a treatment option.

Rigorous screening revealed that 62% of those who accessed the therapy had other sleep disorders, highlighting the importance of proper assessment before starting treatment to ensure effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot evaluation of an online cognitive behavioral therapy for insomnia disorder - targeted screening and interactive Web design lead to improved sleep in a community population. Anderson, KN., Goldsmith, P., Gardiner, A.[2021]

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]

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) 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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4069142/

Sleeping well with cancer: a systematic review of cognitive ... Results suggest that CBT-I is associated with statistically and clinically significant improvements in subjective sleep outcomes in patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04817163

NCT04817163 | Implementation of CBT-I in Cancer Clinics A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered ...

3. sleepmedres.org sleepmedres.org/journal/view.php?number=98

Review Article There is growing evidence that CBT-I is an effective treatment for reducing insomnia in cancer patients and survivors, regardless of cancer ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079222000284

Systematic review and meta-analysis of cognitive ... Overall, CBT-I is a robustly efficacious and durable treatment for insomnia among cancer survivors and can produce concomitant benefits on other symptoms.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pon.5532

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9387101/

Cognitive behavioural therapy for insomnia in people with ... CBT‐I has been found to be as effective as prescription medications for short‐term treatment of chronic insomnia; long‐term CBT‐I might be more effective in ...

7. academic.oup.com academic.oup.com/sleep/article/37/8/1305/2416825?login=false

Is a Video-Based Cognitive Behavioral Therapy for Insomnia ... Despite accumulating evidence supporting its efficacy when administered face-to-face, the accessibility to CBT-I remains extremely limited. Only a few cancer ...

8. link.springer.com link.springer.com/article/10.1007/s40675-015-0021-0

CBT-I in Cancer: We Know It Works, so Why Are We Waiting? However, CBT for insomnia is an evidence-based solution that is not only safe and effective but also has the potential to make long-term ...