Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients

(CBT-I in PBT Trial)

Overseen By Mary Bridgman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Virginia Commonwealth University

Disqualifiers: Major communication difficulties, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

60 Participants Needed

Trial Summary

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 Cognitive Behavioral Therapy for Insomnia (CBT-I) in brain tumor patients?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in improving sleep and overall quality of life in cancer patients, including those with breast cancer. It can be delivered in various formats, such as internet-based or telehealth, making it accessible to more patients. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I), including its digital forms (dCBT-I), has been studied in various populations and is generally considered safe for humans. It is a recommended treatment for insomnia and has been evaluated for safety and acceptability in different groups, including those with brain tumors and cancer survivors. ^{1 3 6 7 8}

How is Cognitive Behavioral Therapy for Insomnia (CBT-I) unique for brain tumor patients?

CBT-I is unique for brain tumor patients because it is delivered through telehealth, making it accessible for those who may have difficulty attending in-person sessions. It is also specifically being evaluated for its feasibility and safety in this population, where insomnia is common but often poorly managed. ^{1 3 6 9 10}

What is the purpose of this trial?

This study seeks to investigate an evidence-based, manualized, behavioral health intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I), in individuals with primary brain tumors (PBT) and insomnia. Our project will assess the feasibility and acceptability of recruitment, enrollment, data collection procedures, and retention of individuals with PBT and insomnia in the behavioral health intervention, CBT-I, and investigate the potential benefits of CBT-I within this at-risk and understudied population. In the long term, the goals are to expand treatment options for neuro-oncology patients and improve their mission readiness and overall wellbeing.

Research Team

Ashlee Loughan, Ph.D

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for individuals with primary brain tumors like glioblastoma, oligodendroglioma, astrocytoma, meningioma, or brain lymphoma who are also experiencing insomnia. Details about specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I had brain surgery more than 2 weeks ago, if that applies to me.

Meets Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V) diagnostic criteria for insomnia

Has a reliable internet connection

Exclusion Criteria

I cannot attend weekly online meetings.

Currently a prisoner or residing in a correctional facility

I am able to understand and sign the consent form.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I) via telehealth

6 weeks

Weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Assessments at Week 18

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview The study tests Cognitive Behavioral Therapy for Insomnia (CBT-I) in patients with primary brain tumors to see if it's feasible and acceptable. It will look at how well the therapy works to improve sleep and overall wellbeing.

Participant Groups

Group I: Telehealth Cognitive Behavioral Therapy for Insomnia Experimental Treatment 1 Intervention

Group II: Enhanced Treatment as Usual Active Control 1 Intervention

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?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Findings from Research

Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) was found to be safe and acceptable for patients with primary brain tumors, with a high enrollment rate of 98% and an 80% retention rate across six sessions.

Participants reported significant improvements in insomnia severity, sleep quality, and fatigue, with these benefits maintained at a 3-month follow-up, indicating the potential efficacy of CBT-I in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth group Cognitive Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm Phase 2 feasibility and proof-of-concept trial. Loughan, AR., Lanoye, A., Willis, KD., 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]

In a pilot study involving 74 breast cancer patients undergoing chemotherapy, Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) significantly improved insomnia symptoms compared to a sleep hygiene pamphlet control.

The effectiveness of BBT-CI was particularly pronounced in patients with lower anxiety levels, those who had undergone previous cancer surgeries, and those with higher baseline symptom severity, suggesting that certain patient characteristics may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy : A pilot study. Palesh, O., Solomon, N., Hofmeister, E., et al.[2021]

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]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

Cognitive behavioral therapy for insomnia (CBTI) is the recommended first-line treatment for insomnia, but its high cost and limited availability of trained providers hinder access, especially for vulnerable groups like military personnel and the elderly.

Digital CBTI (dCBTI) is emerging as a promising and scalable alternative that could improve access to effective insomnia treatment, particularly for those who face barriers to traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. Dopheide, JA.[2021]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

A study involving 44 patients with primary brain tumors will evaluate the feasibility, acceptability, and safety of a six-week group-based Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention delivered via telehealth.

This research aims to determine if CBT-I can effectively address sleep disturbances in this underserved population, potentially leading to broader implementation in neuro-oncology clinics if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial. Loughan, AR., Lanoye, A., Willis, KD., 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

Telehealth group Cognitive Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm Phase 2 feasibility and proof-of-concept trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

A novel approach to management of sleep-associated problems in patients with breast cancer (MOSAIC) during chemotherapy : A pilot study. [2021]

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

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

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

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

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

Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic therapy. [2021]

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

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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