Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Summary

This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female breast cancer patients who report sleep disturbances following completion of chemotherapy.

Timeline

Start

2008-02

Primary completion

2013-04

Completion

2013-04

Outcome

Met primary endpoint

paper both the CBT-I plus A (P = .001) and CBT-I plus P (P = .010) groups had significantly greater reductions in insomnia severity postintervention than the P group PMID 25452447 ↗

Publications

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
• Peoples AR, Garland SN, Pigeon WR, Perlis ML, Wolf JR, Heffner KL, Mustian KM, Heckler CE, Peppone LJ, Kamen CS, Morrow GR, Roscoe JA. Cognitive Behavioral Therapy for Insomnia Reduces Depression in Cancer Survivors. J Clin Sleep Med. 2019 Jan 15;15(1):129-137. doi: 10.5664/jcsm.7586.
• Roscoe JA, Garland SN, Heckler CE, Perlis ML, Peoples AR, Shayne M, Savard J, Daniels NP, Morrow GR. Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. J Clin Oncol. 2015 Jan 10;33(2):165-71. doi: 10.1200/JCO.2014.57.6769. Epub 2014 Dec 1.

Drugs

Indications