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Brain tumor insomnia targeted by CBT in new pilot study

NCT ID NCT06439420

Symptom relief Sponsor: Virginia Commonwealth University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a type of talk therapy called Cognitive Behavioral Therapy for Insomnia (CBT-I) in 70 people with brain tumors who also had trouble sleeping. The therapy involved six weekly group sessions delivered online. The main goal was to see if the approach was practical and acceptable for this group, and to explore whether it might improve sleep and well-being.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-I)
What this could lead to
If this works, it could offer a safe, non-drug way to improve sleep and quality of life for brain tumor patients.
What could go wrong
This is a small pilot study (70 people) focused on feasibility, not proof of effectiveness. Results may not apply to all brain tumor patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

70 people

The number who actually took part.

Started

Jul 2024

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Primary brain tumor diagnosis (grade I-IV) * \>/=2weeks post-cranial resection (if applicable) * \>/=1 month post-radiation therapy (if applicable) * Able to understand, speak, and read English * Absence of major cognitive concerns * Meet Diagnostic and statistical manual of mental disorders version 5 (DSM-V) diagnostic criteria for insomnia * Reliable internet connection Exclusion Criteria: * Major communication difficulties that would prohibit effective intervention * Inability to attend weekly virtual group meetings * Inability to understand and provide informed consent * Currently a prisoner or residing in a correctional facility

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Conditions

The condition(s) this trial relates to.

astrocytoma (excluding glioblastoma) brain cancer glioblastoma glioma insomnia lymphoma meningioma oligodendroglioma primary brain neoplasm primary central nervous system lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Astrocytoma Glioblastoma Meningioma Oligodendroglioma Primary brain tumor Primary central nervous system (CNS) lymphoma

Contacts and locations

Locations

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.