NCT06439420CompletedPhase 2
CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 28 May 2024
- Start date
- 8 Jul 2024
- Primary completion date
- 25 Sept 2025
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Glioblastoma
- NCT number
- NCT06439420
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 70
- From 8 Jul 2024 to the primary completion date, 25 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.