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

Ashlee R Loughan; Autumn Lanoye; Kelcie D Willis; Scott G Ravyts; Amber Fox; Alicia Zukas; Youngdeok Kim

doi:10.1016/j.conctc.2023.101083

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

Contemp Clin Trials Commun. 2023 Feb 1:32:101083. doi: 10.1016/j.conctc.2023.101083. eCollection 2023 Apr.

Authors

Ashlee R Loughan^{1

2}, Autumn Lanoye^{3

2}, Kelcie D Willis⁴, Scott G Ravyts⁴, Amber Fox⁴, Alicia Zukas⁵, Youngdeok Kim⁶

Affiliations

¹ Virginia Commonwealth University, Department of Neurology, USA.
² Virginia Commonwealth University, Massey Cancer Center, USA.
³ Virginia Commonwealth University, Department of Health Behavior and Policy, USA.
⁴ Virginia Commonwealth University, Department of Psychology, USA.
⁵ Medical College of South Carolina, Department of Neurosurgery, USA.
⁶ Virginia Commonwealth University, Department of Kinesiology and Health Sciences, Richmond, VA, USA.

Abstract

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.

Keywords: Cognitive behavioral therapy for insomnia (CBT-I); Feasibility/acceptability; Insomnia; Neuro-oncology; Primary brain tumor; Sleep disturbance.