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.

CBT for Insomnia & Related Anxiety & Depression in Cancer Patients

CBT studyAbstract Objectives: This secondary analysis of data from a randomised controlled trial explores associations between common symptom clusters and evaluates pre-treatment to post-treatment changes in clinical levels of these symptoms following cognitive behaviour therapy for insomnia (CBT-I).

Methods: Baseline data from 113 participants with insomnia were explored to establish rates of and associations between clinical levels of fatigue, anxiety and depression across the sample. Effects of CBT-I on this symptom cluster were also explored by examining changes in pre-treatment to post-treatment levels of fatigue, anxiety and depression.

Results: At baseline, the most common symptom presentation was insomnia + fatigue, and 30% of the sample reported at least three co-morbid symptoms. Post-CBT, the number of those experiencing clinical insomnia and clinical fatigue decreased. There were no changes in anxiety rates from baseline to post-treatment in the CBT group and modest reductions in rates of those with clinical depression. Seven individuals (9.6%) from the CBT group were completely symptom free at post-treatment compared with 0% from the treatment as usual condition. Chi-square analysis revealed a significant relationship between group allocation and changes in symptoms of insomnia and fatigue. No such relationship was found between group allocation and mood variables.

Conclusions: These findings confirm the high rate of symptom co-morbidities among cancer patients and highlight strong associations between sleep and fatigue. CBT-I appears to offer generalized benefit to the symptom cluster as a whole and, specifically, is effective in reducing fatigue, which exceeded clinical cut-offs prior to implementation of the intervention. This has implications for the diagnosis/management of common symptoms in cancer patients.

Fleming, L., Randell, K., Harvey, C., & Espie, C. A. (2014). Does cognitive behaviour therapy for insomnia reduce clinical levels of fatigue, anxiety and depression in cancer patients? Psycho-Oncology, 23, 6, 679-684.

CBT in Specialized Medical Centers

CBT studyThis article is an introduction to the second issue of a two-part special series on integrating cognitive behavioral therapy (CBT) into medical settings. The first issue focused on integrating CBT into primary care, and this issue focuses on implementing CBT in other specialty medical settings, including cancer treatment, HIV care, and specialized pediatric medical clinics. Models for treatment delivery to improve ease of implementation are also discussed, including telehealth and home-delivered treatment. The six articles in this series provide examples of how to transport CBT techniques that are largely designed for implementation in outpatient mental health settings to specialized medical settings, and discuss unique considerations and recommendations for implementation.

Magidson, J. F., & Weisberg, R. B. (2014). Implementing cognitive behavioral therapy in specialty medical settings. Cognitive and Behavioral Practice, 21, 4, 367-371.

Use of CBT for Insomnia in Cancer Patients

CBT studyIndividuals with cancer are disproportionately affected by sleep disturbance and insomnia relative to the general population. These problems can be a consequence of the psychological, behavioral, and physical effects of a cancer diagnosis and treatment. Insomnia often persists for years and, when combined with already high levels of cancer-related distress, may place cancer survivors at a higher risk of future physical and mental health problems and poorer quality of life. The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBT-I), a non-pharmacological treatment that incorporates cognitive and behavior-change techniques and targets dysfunctional attitudes, beliefs, and habits involving sleep. This article presents a comprehensive review of the literature examining the efficacy of CBT-I on sleep and psychological outcomes in cancer patients and survivors. The search revealed 12 studies (four uncontrolled, eight controlled) that evaluated the effects of CBT-I in cancer patients or survivors. Results suggest that CBT-I is associated with statistically and clinically significant improvements in subjective sleep outcomes in patients with cancer. CBT-I may also improve mood, fatigue, and overall quality of life, and can be successfully delivered through a variety of treatment modalities, making it possible to reach a broader range of patients who may not have access to more traditional programs. Future research in this area should focus on the translation of evidence into clinical practice in order to increase awareness and access to effective insomnia treatment in cancer care.

Garland, S. N., Johnson, J. A., Campbell, T., Savard, J., Gehrman, P., Perlis, M., & Carlson, L. (June 18, 2014). Sleeping well with cancer: A systematic review of cognitive behavioral therapy for insomnia in cancer patientsNeuropsychiatric Disease and Treatment, 10, 1113-1123.

Internet-based, CBT Stress Management Workbook for Breast Cancer Patients

Cognitive behavioral stress management groups have been shown to be decrease psychological symptoms and increase adaptive coping in breast cancer patients, but dissemination of this effective intervention has been challenging. The goal of the present project was to develop an online cognitive behavioral stress management intervention for early stage breast cancer survivors and evaluate its effectiveness using a 2 group × 3 time randomized, waitlist-controlled design. Intervention and waitlist control group participants were assessed at three time points: at baseline; at 10 weeks, after which only intervention participants had used the workbook; and at 20 weeks, after which both groups had used the workbook. Results indicate that at 10 weeks intervention participants showed improved self-efficacy for coping with their cancer and for regulating negative mood and lower levels of cancer-related post-traumatic symptoms as compared to the control group, suggesting that an internet stress management intervention could be effective for helping breast cancer patients increase their confidence in their ability to cope with stress.

Carpenter, K. M., Stoner, S. A., Schmitz, K., McGregor, B. A., & Doorenbos, A. Z. (2014). An online stress management workbook for breast cancer. Journal of Behavioral Medicine, 37, 3, 458-468.

CBT Alleviates Treatment-Induced Menopausal Symptoms in Breast Cancer Patients

OBJECTIVE:Many breast cancer patients experience (severe) menopausal symptoms after an early onset of menopause caused by cancer treatment. The aim of this study was to assess the cost-effectiveness of cognitive behavioral therapy (CBT) and physical exercise (PE), compared to a waiting list control                          group (WLC).

METHODS: We performed a cost-effectiveness analysis from a healthcare system perspective, using a Markov model. Effectiveness data came from a recent randomized controlled trial that evaluated the efficacy of CBT and PE. Cost data were obtained from relevant Dutch sources. Outcome measures were incremental treatment costs (ITCs) per patient with a clinically relevant improvement on a measure of endocrine symptoms, the Functional Assessment of Cancer Therapy questionnaire (FACT-ES), and on a measure of hot flushes, the Hot Flush Rating Scale (HFRS), and costs per quality-adjusted life years (QALY) gained over a 5-year time period.

RESULTS: ITCs for achieving a clinically relevant decline on the FACT-ES for one patient were 1,051 for CBT and 1,315 for PE, compared to the WLC. The corresponding value for the HFRS was 1,067 for CBT, while PE was not more effective than the WLC. Incremental cost-utility ratios were 22,502/QALY for CBT and 28,078/QALY for PE.

CONCLUSION: CBT is likely the most cost-effective strategy for alleviating treatment-induced menopausal symptoms in this population, followed by PE. The outcomes are sensitive to a reduction of the assumed duration of the treatment effect from 5 to 3 and 1.5 years.

IMPLICATIONS FOR CANCER SURVIVORS: Patients can be prescribed CBT or, based on individual preferences, PE.

Mewes, J. C., Steuten, L. M. G., Duijts, S. F. A., Oldenburg, H. S. S., Van, B. M., Stuiver, M. M., Hunter, M. S., … Aaronson, N. K. (2014). Cost-Effectiveness of Cognitive-Behavioral Therapy and Physical Exercise for Alleviating Treatment-Induced Menopausal Symptoms in Breast Cancer Patients. Journal of Cancer Survivorship: Research and Practice. Epub ahead of print.

CBT Reduces Menopausal Symptoms Following Breast Cancer Treatment

According to a recent study published in The Lancet, CBT can help reduce menopausal symptoms among women following breast cancer treatment. Menopausal symptoms such as hot flushes and night sweats are fairly prevalent among female breast cancer patients (65-85%) following treatment.  In the current study, researchers sought to determine whether CBT can help breast cancer patients effectively manage menopausal symptoms. Participants included 96 women recruited from breast clinics in London, UK. They were randomly assigned to received either group CBT (90-minute weekly sessions for 6 weeks) or usual care. Assessments were conducted at baseline, 9 weeks, and 26 weeks following intervention. At the 9 week follow up, CBT significantly reduced menopausal symptoms, improved mood, sleep, and quality of life among group CBT participants. These results were maintained at 26 weeks. These findings suggest that incorporating CBT into breast cancer programs may be beneficial to breast cancer survivors with problematic menopausal symptoms.

Mann, E., Smith, M. J., Hellier, J., Balabanovic, J. A., Hamed, H., Grunfeld, E. A., & Hunter, M. S. (2012). Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncology, 13, 3, 309-318.

Cognitive Behavior Therapy of Anxiety for Terminal Cancer Patients

Patients suffering from terminal cancer are often plagued by anxiety over disease progression, pain, decreased functioning, and death. Cognitive Behavior Therapy (CBT) interventions for anxiety are designed to help clients test the reality and functionality of undue worrying. Geer, Park, Prigerson, and Safren (2010) indicate that excessive anxiety may lead to treatment non-adherence, and further diminish quality of life for these patients. The authors propose tailoring CBT to better serve this population.

Three case studies of patients, with incurable lung cancer, were presented in this article.  The patients showed decreased anxiety, improvement in quality of life, ability to manage stress more effectively, and improved communication with family and friends. The authors concluded, “Our tailored treatment approach helped patient gain a sense of personal control and improve quality of life in the face of an uncertain future and unpredictable disease course;” they also added that further research for treating this population of patients with CBT is needed.

The CBT treatment, described by these authors, for terminal cancer patients with anxiety was divided into four modules: “1) psychoeducation and goal setting; 2) relaxation training; 3) coping with cancer fears; and 4) activity planning and pacing.”  Treatment was aimed towards helping patients learn coping skills that reduce anxiety, as well as develop skills in managing symptoms of cancer and the side effects of chemotherapy. This protocol recommends a total of 6 to 7 intensive sessions.

Geer, J.A., Park E.R., Prigerson,H.G., and Safren, S.A. (2010). Tailoring cognitive-behavioral therapy to treat anxiety comorbid with advanced cancer. Journal of Cognitive Psychotherapy. 1; 24(4): 294-313. doi:10.1891/0889-8391.24.4.294.

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.