Effect of cognitive behavioral therapy for insomnia (CBT-I) and/or armodafinil on insomnia in cancer survivors.

9531 Background: Insomnia is an underreported distressing side effect of cancer and its treatment, which can persist for months after treatment affecting the course of cancer survival. It exacerbates fatigue and results in reduced quality of life (QOL), allowing for the possibility that treatment of insomnia may improve associated symptoms and QOL. Although CBT-I is considered the nonpharmacologic treatment of choice for insomnia in the general population, it often results in short-term daytime sleepiness. The present study examines whether CBT-I in combination with a wakefulness promoting agent, armodafinil (A), results in greater overall reduction in insomnia in cancer survivors. Methods: Primary analyses examine if one or more of the intervention conditions (i.e., CBT-I, A, or both), when compared to placebo (P) group, reduce insomnia in cancer patients following completion of chemotherapy and/or radiotherapy. We report on 88 cancer survivors (mean age 56, 88% female, breast cancer 68%) randomized to one of four 7-week long intervention conditions: 1) CBT-I+A, 2) CBT-I+P, 3) A only, and 4) P only. Insomnia severity was assessed by the validated Insomnia Severity Index (ISI) questionnaire at consent, following the intervention (post), and again three months later (follow-up), with higher scores indicating greater insomnia. Results: Mean post ISI scores in groups 1-4 were 4.12, 5.61, 11.32, and 10.28, respectively. ANCOVA with multiple imputation and controlling for scores at time of consent showed that both CBT-I+A (p=0.001) and CBT-I+P (p=0.01) groups had significantly less insomnia than those in the placebo group, with effect sizes of 1.31 and 1.02, respectively. Armodafinil and placebo groups were not significantly different (p=0.584); nor was the CBT-I+A group significantly different from the CBT-I+P group (p=0.421). Follow-up ISI scores were essentially the same as post scores. Conclusions: These findings show that CBT-I results in clinically significant improvement in insomnia, with effects that persist long term. Armodafinil had no significant effect on insomnia nor on the efficacy of CBT-I. Supported by NCI grant 5 R01 CA126968. Study medication was provided by Teva Pharmaceutical USA. Clinical trial information: NCT01091974.