CBT-I for Insomnia in Cancer Patients

Recruiting in Palo Alto (17 mi)

Overseen by Josée Savard, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CHU de Quebec-Universite Laval

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

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new way to help cancer patients with insomnia using a step-by-step treatment plan. It starts with an online self-help program and adds therapy sessions if needed. The goal is to see if this method works well in real-world cancer clinics.

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 data supports the effectiveness of the treatment CBT-I for Insomnia in Cancer Patients?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in improving sleep for cancer patients, with studies indicating significant improvements in sleep efficiency and reductions in insomnia severity. Additionally, online and video-based CBT-I have been found feasible and effective, offering accessible options for patients. ^{1 2 3 4 5}

Is CBT-I safe for cancer patients?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for cancer patients, as studies have shown it to be a feasible and acceptable treatment with high satisfaction and retention rates among participants. ^{2 4 5 6 7}

How is the web-based CBT-I treatment for insomnia in cancer patients different from other treatments?

Web-based CBT-I is unique because it allows cancer patients to access cognitive-behavioral therapy for insomnia online, making it more accessible for those who may have difficulty traveling to in-person sessions. This approach is particularly beneficial for cancer survivors who often face barriers like distance to treatment centers and a lack of trained providers. ^{1 4 6 7 8}

Research Team

Josée Savard, Ph.D.

Principal Investigator

Centre de recherche du CHU de Québec-Université Laval

Eligibility Criteria

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 am 18 years old or older.

I have been diagnosed with cancer that has not spread.

You need to have an Internet connection.

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

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

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+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

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]

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]

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]

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]

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]

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. 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]

3. New Zealand 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. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

A pilot trial of brief group cognitive-behavioral treatment for insomnia in an adult cancer survivorship program. [2022]

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]