Nationally recruited telehealth group-based Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumors: A randomized NIH ORBIT Phase IIc study.

Background: Sleep disturbance is common and undertreated in adults with primary brain tumors. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line, non-pharmacological treatment, yet its benefit in neuro-oncology has yet to be evaluated. This Phase IIc pilot assessed feasibility, acceptability, and meaningful effects of telehealth group-based CBT-I versus treatment as usual (TAU) in neuro-oncology. Methods: Adults with primary brain tumors and chronic insomnia were randomized 1:1 to 6 weekly CBT-I sessions or TAU. Primary outcomes were feasibility of recruitment and longitudinal data collection, acceptability of CBT-I and study procedures, and changes in patient-reported insomnia severity, fatigue, and sleep quality. Results: Recruitment met a priori feasibility benchmarks: Of the 84 patients screened, 96% were eligible, 86% consented, and 60 were randomized (CBT-I Conclusions: Telehealth CBT-I is feasible, acceptable, and shows a promising benefit signal in adults with primary brain tumors, particularly for improving insomnia. Future trials should optimize procedures for neurocognitive and accelerometer longitudinal data collection to support fully powered efficacy studies. Trial Registration: ClinicalTrials.gov Identifier: NCT06439420.