title: Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment.
abstract: OBJECTIVE
  Insomnia is a distressing and often persisting consequence of cancer. Although cognitive behavioral therapy for insomnia (CBT-I) is the treatment of choice in the general population, the use of CBT-I in patients with cancer is complicated, because it can result in transient but substantial increases in daytime sleepiness. In this study, we evaluated whether CBT-I, in combination with the wakefulness-promoting agent armodafinil (A), results in better insomnia treatment outcomes in cancer survivors than CBT-I alone.
  
  
  METHODS
  We report on a randomized trial of 96 cancer survivors (mean age, 56 years; female, 87.5%; breast cancer, 68%). The primary analyses examined whether ≥ one of the 7-week intervention conditions (ie, CBT-I, A, or both), when compared with a placebo capsule (P) group, produced significantly greater clinical gains. Insomnia was assessed by the Insomnia Severity Index and sleep quality by the Pittsburgh Sleep Quality Inventory. All patients received sleep hygiene instructions.
  
  
  RESULTS
  Analyses controlling for baseline differences showed that 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, with effect sizes of 1.31 and 1.02, respectively. Similar improvements were seen for sleep quality. Gains on both measures persisted 3 months later. CBT-I plus A was not significantly different from CBT-I plus P (P = .421), and A alone was not significantly different from P alone (P = .584).
  
  
  CONCLUSIONS
  CBT-I results in significant and durable improvements in insomnia and sleep quality. A did not significantly improve the efficacy of CBT-I or independently affect insomnia or sleep quality.
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada. joseph_roscoe@urmc.rochester.edu.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Roscoe
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Sheila N
authors.initials: SN
authors.lastname: Garland
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Heckler
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Perlis
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Anita R
authors.initials: AR
authors.lastname: Peoples
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Michelle
authors.initials: M
authors.lastname: Shayne
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Josée
authors.initials: J
authors.lastname: Savard
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Nina P
authors.initials: NP
authors.lastname: Daniels
authors.affiliation: Joseph A. Roscoe, Charles E. Heckler, Anita R. Peoples, Michelle Shayne, Nina P. Daniels, and Gary R. Morrow, University of Rochester, Rochester, NY; Sheila N. Garland and Michael L. Perlis, University of Pennsylvania, Philadelphia, PA; and Josée Savard, Université Laval, Quebec City, Quebec, Canada.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Morrow
mesh_terms: D001559:Benzhydryl Compounds / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000628:therapy; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009369:Neoplasms / Q000628:therapy*; D012720:Severity of Illness Index; D012890:Sleep; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D064690:Wakefulness-Promoting Agents / Q000627:therapeutic use*
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil