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Cognitive Behavioral Therapy Improves Insomnia After Cancer Treatment With No Difference in Combination With Placebo or Armodafinil

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Key Points

  • Cognitive behavioral therapy plus placebo or armodafinil decreased severity of insomnia, with no significant difference between treatments.
  • Cognitive behavioral therapy plus placebo or armodafinil improved sleep quality, with no significant difference between treatments.

In a study reported in Journal of Clinical Oncology, Roscoe et al found that cognitive behavioral therapy combined with placebo or the wakefulness-promoting agent armodafinil (Nuvigil) had similar beneficial effects on insomnia and sleep quality in cancer survivors.

Study Details

In the study, 96 patients with chronic insomnia (mean age = 56 years, 87.5% female, 68% with breast cancer) were randomly assigned to receive 7 weeks of cognitive behavioral therapy plus placebo (n = 24), cognitive behavioral therapy plus armodafinil (n = 23), placebo (n = 25), or armodafinil (n = 25). Insomnia was assessed by the Insomnia Severity Index and sleep quality by the Pittsburgh Sleep Quality Inventory. All patients received sleep hygiene instructions. Insomnia Severity Index scores of 0 to 7 indicate absence of insomnia, 8 to 14 subthreshold insomnia symptoms, 15 to 21 moderate insomnia, and 22 to 28 severe insomnia. Pittsburgh Sleep Quality Inventory scores of < 5 indicate good sleep quality.

Improvements in Insomnia and Sleep Quality

Analyses of insomnia severity after the intervention controlling for baseline differences showed that both the cognitive behavioral therapy plus armodafinil (mean severity = 3.35, P = .001 vs placebo) and cognitive behavioral therapy plus placebo groups (5.61, P = .010 vs placebo) had significantly greater reductions than the placebo group (10.47), with no difference between the placebo group and the armodafinil group (12.17, P = .584). There was no difference between the cognitive behavioral therapy plus placebo and cognitive behavioral therapy plus armodafinil group (P = .421).

Analysis of sleep quality also showed better quality in the cognitive behavioral therapy plus placebo (mean score 4.69, P = .008 vs placebo) and cognitive behavioral therapy plus armodafinil groups (4.21, P = .002 vs placebo) vs the placebo group (8.32), with no differences between placebo and armodafinil (9.46, P = .257) or for cognitive behavioral therapy plus placebo vs cognitive behavioral therapy plus armodafinil (P = .494).

Gains in both the cognitive behavioral therapy plus placebo and cognitive behavioral therapy plus armodafinil groups persisted at 3 months.

The investigators concluded: “[Cognitive behavioral therapy]… results in significant and durable improvements in insomnia and sleep quality. [Armodafinil] did not significantly improve the efficacy of [cognitive behavioral therapy]…or independently affect insomnia or sleep quality.”

Joseph A. Roscoe, PhD, of University of Rochester Medical Center, is the corresponding author for the Journal of Clinical Oncology article.

The study was supported by National Cancer Institute grants and by Teva Pharmaceuticals. For full disclosures of the study authors, visit jco.ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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