Randomized Placebo-Controlled Trial of Cognitive Behavioral Therapy and Armodafinil for Insomnia After Cancer Treatment

New Study (1)Abstract


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.


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.


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).


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

Roscoe, J.A., Garland, S.N., Heckler, C.E., Perlis, M.L., Peoples, A.R., Shayne, M.,…Morrow, G.R. (2015). Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment. Journal of Clinical Oncology, 33(2), 165-171. doi: 10.1200/JCO.2014.57.6769.

Terapia Cognitiva Conductal [The Many Applications of Cognitive Therapy]

Dr. Beck discusses the many different applications of cognitive behavior therapy (CBT)—and states that he never would have expected CBT to be utilized in the treatment of so many different conditions. For example, CBT can be useful in the treatment of patients with epilepsy; it can reduce the likelihood of additional heart attacks among cardiac patients; and it can help with cancer-related depression.

CBT for Smoking Cessation among Cancer Patients

Smoking, alcohol use and depression often co-exist at high rates among patients with head and neck cancer. Researchers recently designed a randomized, controlled study to see whether patients with head and neck cancer and at least one of the above traits improved with integrated Cognitive Behavior Therapy (CBT) that addressed all of the above factors.

184 patients were randomly assigned to either usual care or 9-11 CBT phone sessions plus optional medications over a period of six months. At the end of the trial, those in the CBT group had significantly improved their smoking cessation rate as compare to those in the usual care group (47% compared to 31%).

The study suggests that an integrated CBT approach, which treats smoking cessation, alcohol and depression simultaneously, may improve smoking cessation rates and provide a more practical means of addressing these co-morbid factors.

Research Results: Group CBT Reduces Anxiety among Women with Breast Cancer

A new study published in the American Journal of Psychiatry shows that group Cognitive Behavior Therapy (CBT) can reduce unwanted thoughts, anxiety and stress among women who have recently had breast cancer surgery. For this study, 199 women who had recently had breast cancer surgery were randomly assigned to one of two groups — they received either 10 weeks of group CBT, or a one-day seminar following surgery. The University of Miami, Florida team that conducted the study observed the women for one year, and found that those who had received group CBT had significantly less anxiety, intrusive cancer-related thoughts, emotional distress, and overall life stress than those in the control group. These improvements were maintained during the year post-treatment.

Research Results: CBT Reduces Fatigue among Cancer Survivors

A new study just published in the Journal of Clinical Oncology shows that Cognitive Behavior Therapy (CBT) can help cancer survivors who are experiencing severe fatigue and functional impairment. If you know someone who has been cured of his or her cancer, but has unexplained fatigue, you may want to check out this study.

112 cancer survivors with severe fatigue were randomly assigned to one of two groups — half of them received CBT, and the other half was assigned to a waitlist for therapy (i.e. they did not receive therapy during the six month timeframe of the study). The group that received CBT treatment showed significantly reduced fatigue and functional impairment as compared to the control group.