Primary Brain TumorPhase 2CBT-I in PBTNCT06439420
CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
A Phase 2 study testing Cognitive Behavioral Therapy for Insomnia in people with Primary Brain Tumor and Glioblastoma, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Brain Tumor, Glioblastoma, Astrocytoma
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 25 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot 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.
- Conditions
- Primary Brain Tumor, Glioblastoma, Astrocytoma, Oligodendroglioma, Meningioma, Primary Central Nervous System (CNS) Lymphoma
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Brain Tumor, Insomnia, Glioma, Sleep
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Meningioma, Lymphoma, Sleep Initiation and Maintenance Disorders, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
CBT-I is a non-pharmacological approach to treating sleep disturbance consisting of educational, behavioral, and cognitive intervention components with evidence-based strategies including sleep efficiency, stimulus control, and sleep hygiene modification. CBT-I includes at least 6 group sessions, each approximately 90 minutes in length, delivered over 6 weeks via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Cognitive Behavioral Therapy for Insomnia | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Enhanced Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of consent to screening procedures
Number of participants that consent to screening procedures
Measured: Baseline (Day 1)
Rate of those eligible enrolling
Number of participants that are eligible to enroll to the protocol
Measured: Baseline (Day 1)
Rate of baseline assessment completion
Number of participants that complete the baseline assessment
Measured: Week 1
Rate of post-intervention assessment completion
The number of participants that complete the post-intervention assessment
Measured: Week 6
Rate of follow-up assessment completion
The number of participants that complete the follow-up assessment
Measured: Week 18
Rate of intervention attrition
The number of participants that do not complete the CBT-I intervention
Measured: Week 6
Acceptability of quantity of assessments
Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best
Measured: Week 18
Acceptability of timing of assessments
Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best
Measured: Week 18
Acceptability of duration of assessments
Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start8 Jul 2024
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashlee Loughan, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439420
- Sponsor's protocol ID
- MCC-23-20323
- Other IDs
- HM20028336
- Acronym
- CBT-I in PBT
- Status last verified
- Sep 2025
- First submitted
- 28 May 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data.
Publications
Loughan AR, Lanoye A, Willis KD, Fox A, Bridgman M, Wages N, Kim Y, Zukas A, Kleva C. Nationally recruited telehealth group-based Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumors: A randomized NIH ORBIT Phase IIc study. Neurooncol Adv. 2026 Aug 31;8(1):vdag226. doi: 10.1093/noajnl/vdag226. eCollection 2026 Jan-Dec.
PubMed 42819807
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
- ClinicalTrials.gov ID
- NCT06439420
- Acronym / sponsor ID
- CBT-I in PBT / MCC-23-20323
- Conditions
- Primary Brain Tumor, Glioblastoma, Astrocytoma, Oligodendroglioma, Meningioma, Primary Central Nervous System (CNS) Lymphoma
- Keywords
- Brain Tumor, Insomnia, Glioma, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Enhanced Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaCBT-I is a non-pharmacological approach to treating sleep disturbance consisting of educational, behavioral, and cognitive intervention components with evidence-based strategies including sleep efficiency, stimulus control, and sleep hygiene modification. CBT-I includes at least 6 group sessions, each approximately 90 minutes in length, delivered over 6 weeks via telehealth. | Behavioural | Telehealth Cognitive Behavioral Therapy for Insomnia |
Primary outcome
Rate of consent to screening procedures
Time frame: Baseline (Day 1)
Number of participants that consent to screening procedures
Rate of those eligible enrolling
Time frame: Baseline (Day 1)
Number of participants that are eligible to enroll to the protocol
Rate of baseline assessment completion
Time frame: Week 1
Number of participants that complete the baseline assessment
Rate of post-intervention assessment completion
Time frame: Week 6
The number of participants that complete the post-intervention assessment
Rate of follow-up assessment completion
Time frame: Week 18
The number of participants that complete the follow-up assessment
Rate of intervention attrition
Time frame: Week 6
The number of participants that do not complete the CBT-I intervention
Acceptability of quantity of assessments
Time frame: Week 18
Satisfaction rating of quantity of assessments on a scale of 1-5 with 5 being the best
Acceptability of timing of assessments
Time frame: Week 18
Satisfaction ratings of timing of assessments on a scale of 1-5 with 5 being the best
Acceptability of duration of assessments
Time frame: Week 18
Satisfaction ratings of duration of assessments on a scale of 1-5 with 5 being the best
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 42819807Loughan AR, Lanoye A, Willis KD, Fox A, Bridgman M, Wages N, Kim Y, Zukas A, Kleva C. Nationally recruited telehealth group-based Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumors: A randomized NIH ORBIT Phase IIc study. Neurooncol Adv. 2026 Aug 31;8(1):vdag226. doi: 10.1093/noajnl/vdag226. eCollection 2026 Jan-Dec.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashlee Loughan, Ph.D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive Behavioral Therapy for Insomnia in people with Primary Brain Tumor and Glioblastoma, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of consent to screening procedures (time frame: Baseline (Day 1)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.