Heckler, C.E., Garland, S.N., Peoples, A.R., Perlis, M.L., Shayne, M., Morrow, G.R., . . . Roscoe, J.A. (2016). Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: A randomized placebo-controlled trial. Supportive Care in Cancer, 24, 2059–2066.
To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.
Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.
Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI; p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.
CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.
This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.