Study protocol for Cognitive Behavioral Therapy for Insomnia in patients with primary brain tumor: A single-arm phase 2a proof-of-concept trial

Background: Sleep disturbance is among the most common symptoms endorsed by patients with primary brain tumor (PwPBT), with many reporting clinically elevated insomnia and poor management of their sleep-related symptoms by their medical team. Though Cognitive Behavioral Therapy for Insomnia (CBT-I) remains the front-line treatment for sleep disturbance, CBT-I has yet to be evaluated in PwPBT. Thus, it is unknown whether CBT-I is feasible, acceptable, or safe for patients with primary brain tumors. Methods: PwPBT (N = 44) will enroll and participate in a six-week group-based CBT-I intervention delivered via telehealth. Feasibility will be based on pre-determined metrics of eligibility, rates and reasons for ineligibility, enrollment, and questionnaire completion. Acceptability will be measured by participant retention, session attendance, satisfaction ratings, and recommendation to others. Safety will be assessed by adverse event reporting. Sleep will be measured both objectively via wrist-worn actigraphy and subjectively via self-report. Participants will also complete psychosocial questionnaires at baseline, post-intervention, and three-month follow-up. Conclusion: CBT-I, a non-pharmacological treatment option for insomnia, has the potential to be beneficial for an at-risk, underserved population: PwPBT. This trial will be the first to assess feasibility, acceptability, and safety of CBT-I in PwPBT. If successful, this protocol will be implemented in a more rigorous phase 2b randomized feasibility pilot with the aim of widespread implementation of CBT-I in neuro-oncology clinics