NCT06439420

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for Insomnia	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.

Timeline

• Start date: 2024-07-08
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2024-06-03
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States