Improving insomnia in patients with primary brain tumors using cognitive behavioral therapy: results from an nrg ncorp pilot trial

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 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. METHODS PwPBT were recruited locally by direct referral and fliers, and nationally by social media support group postings. Forty PwPBT and insomnia enrolled in a six-week group-based telehealth CBT-I phase IIa single-arm proof-of-concept trial: 50.0% female, 68.2% non-Hispanic white, 55.0% high-grade, 42.5% oligodendroglioma, Mage = 52.4 (SD = 12.0, range 31-77). Participants completed data collection at baseline and post-intervention. Self-report measures assessed insomnia (ISI), fatigue (BFI), mood (PHQ-9, GAD-7) and quality-of-life (QLQ-30). Cognitive assessment included measures of attention (WAIS-IV Digits, TMT), verbal fluency (COWAT) and memory (HVLT). Intervention effects for self-report outcomes were analyzed using paired t-tests; effects for cognitive outcomes were analyzed using repeated-measures ANCOVA controlling for age. RESULTS Among those with complete data (n=34), significant improvements were identified for insomnia (t(33) = 8.6, p < .001, Cohen’s d = 1.5) and fatigue (t(30) = 4.7, p < .001, Cohen’s d = 0.8) symptoms. Depression (t(33) = 5.2, p < .001, Cohen’s d = 0.9) and anxiety symptoms (t(33) = 4.2, p < .001, Cohen’s d = 0.7) also improved. Quality-of-life improved with respect to role (t(33) = 2.8, p = .01, Cohen’s d = 0.5), emotional (t(33) = 2.8, p = .01, Cohen’s d = 0.5), cognitive (t(33) = 3.9, p < .001, Cohen’s d = 0.7), and social functioning (t(33) = 3.5, p = .001, Cohen’s d = 0.6)—but not physical functioning (t(33) = 0.5, p = .60, Cohen’s d = 0.1). No clinically or statistically significant cognitive changes were found. CONCLUSION This trial is the first to preliminarily assess efficacy of CBT-I, a non-pharmacological treatment for insomnia, in PwPBT. Results suggest promising benefit of CBT-I in insomnia severity, fatigue, mood, and most quality-of-life indices for individuals challenged by PBT and insomnia. These findings support further study in a scientifically rigorous phase IIb randomized feasibility trial.