Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients

(CBT-I in PBT Trial)

MB
Overseen ByMary Bridgman
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Virginia Commonwealth University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Cognitive Behavioral Therapy for Insomnia (CBT-I) in helping people with primary brain tumors who struggle with sleep. The main goal is to determine if this therapy can serve as a useful treatment option, enhancing overall wellbeing. Participants are divided into two groups: one receives regular care, while the other undergoes CBT-I through online sessions. Suitable candidates have a primary brain tumor, a diagnosis of insomnia according to standard guidelines, and the ability to attend weekly virtual meetings. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

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 Cognitive Behavioral Therapy for Insomnia is safe for individuals with primary brain tumors?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe for individuals with sleep difficulties. Studies have found that delivering CBT-I through telehealth is practical and well-received by patients, including those with primary brain tumors. A small initial trial demonstrated that this approach is safe and effective, with many participants continuing the treatment. Additionally, reviews of multiple studies confirm the safety of CBT-I, highlighting its long-lasting benefits without the side effects often associated with medications. This suggests that CBT-I is a well-tolerated option for improving sleep without significant negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about Telehealth Cognitive Behavioral Therapy for Insomnia (CBT-I) in brain tumor patients because it offers a unique, remote approach to managing sleep issues. Unlike traditional in-person therapy, this telehealth method can be accessed from the comfort of a patient's home, making it more convenient and accessible, especially for those with mobility challenges. Additionally, CBT-I doesn’t rely on medication, reducing the risk of side effects and drug interactions, which can be particularly beneficial for patients who are already managing complex health conditions.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia might be an effective treatment for insomnia in brain tumor patients?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively improves sleep for many people, including cancer survivors and those with brain injuries. One study found that online CBT-I with clinician support offers significant benefits for insomnia and related issues. Another review demonstrated that CBT-I greatly reduces insomnia symptoms in numerous studies involving thousands of people. This therapy combines methods that address the behaviors and thoughts causing insomnia. In this trial, participants will receive either Telehealth Cognitive Behavioral Therapy for Insomnia or Enhanced Treatment as Usual. Although researchers have not specifically tested CBT-I in patients with primary brain tumors, its success in similar groups suggests it might help those with brain tumors manage their insomnia as well.678910

Who Is on the Research Team?

AL

Ashlee Loughan, Ph.D

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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

Meets Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V) diagnostic criteria for insomnia
Has a reliable internet connection
I had brain surgery more than 2 weeks ago, if that applies to me.
See 4 more

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Telehealth Cognitive Behavioral Therapy for InsomniaExperimental Treatment1 Intervention
Group II: Enhanced Treatment as UsualActive Control1 Intervention

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

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Approved in United States as CBT-I for:
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Approved in European Union as CBT-I for:
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Approved in United States as Somryst for:
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Approved in United Kingdom as Sleepio for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

Published Research Related to This Trial

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

Citations

Telehealth group Cognitive–Behavioral Therapy for Insomnia ...Cognitive Behavioral Therapy for Insomnia (CBT-I) is a nonpharmacological treatment for sleep, never trialed in patients with primary brain tumors (PwPBT).
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 ...
Systematic review and meta-analysis on fully automated ...This systematic review and meta-analysis evaluated the effectiveness of FA dCBT-I across 29 randomized controlled trials (RCTs) involving 9475 participants.
main outcomes of a randomized dismantling trialCBT-I combines 2 component interventions that target distinct factors that contribute to insomnia symptoms: behavioral therapy (BT) and ...
Internet-Guided Cognitive Behavioral Therapy for Insomnia ...These findings suggest that when successfully completed, eCBT-I can provide clinical benefits in military service members and veterans with TBI and insomnia.
6.pubmed.ncbi.nlm.nih.govpubmed.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 ...
Study protocol for Cognitive Behavioral Therapy ...This trial will be the first to assess feasibility, acceptability, and safety of CBT-I in PwPBT. If successful, this protocol will be implemented in a more ...
A randomized controlled trial of a digital cognitive ...Meta-analyses support CBT-I as efficacious and safe, with long-lasting effects in older adults. As a behavioral rather than pharmacological ...
CBT for Insomnia in Primary Brain Tumor Patients | ...The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Cognitive Behavior Therapy for Insomnia (CBT-I) in ...
Telehealth group Cognitive–Behavioral Therapy for Insomnia ...Overall, there was an 80% retention rate for the 6-session telehealth group CBT-I intervention. All participants endorsed moderate-to-strong ...
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