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 Treatment for Insomnia Improves Patient Outcomes while Reducing Healthcare Costs and Utilization

Study Objectives: To examine health care utilization (HCU) and costs following brief cognitive behavioral treatment for insomnia (bCBTi).

Methods: Reviewed medical records of 84 outpatients [mean age = 54.25 years (19.08); 58% women] treated in a behavioral sleep medicine clinic (2005-2010) based in an accredited sleep disorders center. Six indicators of HCU and costs were obtained: estimated total and outpatient costs, estimated primary care visits, CPT costs, number of office visits, and number of medications. All patients completed ? 1 session of bCBTi. Those who attended ? 3 sessions were considered completers (n = 37), and completers with significant sleep improvements were considered responders (n = 32).

Results: For completers and responders, all HCU and cost variables, except number of medications, significantly decreased (ps < 0.05) or trended towards decrease at post-treatment. Completers had average decreases in CPT costs of $200 and estimated total costs of $75. Responders had average decreases in CPT costs of $210. No significant decreases occurred for non-completers.

Conclusions: bCBTi can reduce HCU and costs. Response to bCBTi resulted in greater reduction of HCU and costs. While limited by small sample size and non-normal data distribution, the findings highlight the need for greater dissemination of bCBTi for several reasons: a high percentage of completers responded to treatment, as few as 3 sessions can result in significant improvements in insomnia severity, bCBTi can be delivered by novice clinicians, and health care costs can reduce following treatment. Insomnia remains an undertreated disorder, and brief behavioral treatments can help to increase access to care and reduce the burden of insomnia.

McCrae, C. S., Bramoweth, A. D., Williams, J., Roth, A., & Mosti, C. (2014). Impact of brief cognitive behavioral treatment for insomnia on health care utilization and costs. Journal of Clinical Sleep Medicine, 10, 2, 127-35.

Group CBT for Insomnia: A Meta-Analysis

Insomnia is the most common sleep disorder among the general population. Although cognitive behavioral therapy for insomnia (CBT-I) is the psychological treatment of choice, the availability of individual therapy is often not sufficient to meet the demand for treatment. Group treatment can increase the efficiency of delivery, but its efficacy has not been well-established. Randomized controlled trials (RCTs) comparing group CBT-I to a control group in patients with insomnia were identified. A review of 670 unique citations resulted in eight studies that met criteria for analysis. Outcome variables included both qualitative (e.g., sleep quality) and quantitative (e.g., sleep diary) outcomes, as well as depression and pain severity, at both pre- to post-treatment and follow-up (3-12 mo post-treatment). Overall, we found medium to large effect sizes for sleep onset latency, sleep efficiency, and wake after sleep onset and small effect sizes for pain outcomes. Effect sizes remained significant at follow-up, suggesting that treatment gains persist over time. Other variables, including total sleep time, sleep quality, and depression, showed significant improvements, but these findings were limited to the within treatment group analyses. It is clear that group CBT-I is an efficacious treatment. Implications for stepped care models for insomnia are discussed.

Koffel, E., Koffel, J., & Gehrman, P. (May 01, 2014). A Meta-analysis of Group Cognitive Behavioral Therapy for Insomnia. Sleep Medicine Reviews.

Individual versus Group Cognitive Behavior Therapy for Insomnia

Cognitive behavior therapy for insomnia (CBT-I) has been identified as an effective treatment for primary insomnia, and according to a recent study published in Sleep and Biological Rhythms, individual CBT-I may be a superior treatment approach to group CBT-I.

In the current study, researchers compared the short-term effectiveness of both individual and group CBT-I, in individuals who met DSM-IV-TR criteria for primary insomnia (i.e., a fear of insomnia, increased somatic tension, and mental arousal in bed).  In addition to primary diagnoses of insomnia, all participants in the study also reported chronic use of hypnotics and engaged in either individual CBT-I (n=20) or group CBT-I (n=25).  Both groups were exposed to the same major treatment components, including education concerning sleep hygiene, as well as stimulus control, sleep restriction, and cognitive therapies.  Pre and post-treatment evaluations utilized sleep logs, the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS), the Pittsburgh Sleep Quality Index (PSQI) and actigraphy (a non-invasive method of monitoring human rest/activity cycles) to assess sleep outcomes between participant groups.

Findings revealed that overall, both individual and group CBT-I produced positive sleep outcomes.  However, across multiple objective and subjective sleep measurements, individual CBT-I resulted in significantly greater participant gains over group CBT-I.  These results support the use of individual CBT-I above group CBT-I when treating primary insomnia.

Yamadera, W., Sato, M., Harada, D., Iwashita, M., Aoki, R., Obuchi, K., Ozone, M., … Nakayama, K. (July 07, 2013). Comparisons of short-term efficacy between individual and group cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms, 11, 3, 176-184.

For professional trainings and seminars in CBT for insomnia, visit:

Community-Based CBT Workshop for Insomnia

According to a recent study published in the Journal of Sleep Research community-based, Cognitive Behavior Therapy for Insomnia (CBT-I) workshops can be effective and accessible for participants suffering from symptoms of insomnia. Although insomnia is highly prevalent, individuals seek help infrequently and accessibility of treatment is often limited. The current study examined the effectiveness of large scale, one-day CBT-I workshops. These workshops were advertised and open to the public. Those who participated (n=151) were randomly assigned to either attend an experimental workshop and follow up sessions immediately (n=75), or to the waitlist control group (n=76).

The CBT-I workshops were significantly effective in reducing insomnia symptoms among participants at a 3-month follow-up. According to ratings on the insomnia severity index, symptoms reduced 17.6% in the experimental group, but only 3.5% in the control group. Participants also completed sleep diaries which support these results. The workshops proved to be accessible to the public, as 50% of participants had never sought help in the past. Further, they were rated as “very high” in satisfaction, with 90% of participants feeling “mostly or completely satisfied.”

This study indicates that treatment for insomnia can be delivered quickly and effectively within a large group (about 30 participants at one time). Further, CBT-I workshops designed for the public may increase the accessibility of effective treatment for individuals who might not otherwise seek help.

Swift, N., Stewart, R., Andiappan, M., Smith, A., Espie, C.A., & Brown, J.S.L. (2012) The effectiveness of community day-long CBT-I workshops for participants with insomnia symptoms: a randomized controlled trial. Journal of Sleep Research, 21, 270-280.

Cognitive-Behavioral Therapy is Effective for Insomnia

newstudy-graphic-66x60.jpgData continues to emerge about the public health and economic burden of insomnia. This data comes from increased health risks including increased utilization of health care and work domain deficits such as absenteeism and reduced productivity. The National Institutes of Health Consensus and the American Academy of Sleep Medicine Practice Parameters have made the recommendation that cognitive-behavioral therapy (CBT) be the standard treatment for insomnia. CBT for insomnia is a brief, non-pharmacologic approach that is based on the science of sleep medicine, behavior change, and psychosocial theory. Further, in randomized controlled trials in which CBT is compared to medication, CBT has proven to be comparably effective, with more durable long-term maintenance of gains after treatment is discontinued. To read the entire article, click here:

All-male CBT workshops effective for men with insomnia

CBT has been successfully used to treat insomnia in both men and women, but according to a recent article men tend to seek treatment less often than women. Even when they consult their primary care providers, those providers are often unaware of CBT’s effectiveness and may have limited CBT resources to offer their patients.

To address this, researchers offered group CBT in the form of 1-day, all-male CBT workshops. The study ran six months, and drew 111 inquiries, some of them self-referred. The researchers noted that roughly half of the participants had not mentioned their insomnia to their primary care providers. In a six-week follow-up, the men “reported significant improvements in their sleep, as well as reductions in their depression.”

–Read more about CBT for insomnia.

Forbes Magazine: Patient Fix Thyself… Cognitive Behavior Therapy… may be better than Prozac


“Dump the Couch! And ditch the Zoloft. A new therapy revolution is here,” says the cover of the April, 2007 issue of Forbes Magazine.

Forbes is referring to Cognitive Behavior Therapy (CBT), which has “been shown to be surprisingly effective in quelling an ever expanding array of mental maladies: depression, anxiety, panic attacks, obsessive-compulsive disorder, post-traumatic stress syndrome, bulimia, hypochondria–even insomnia. Now almost 150 clinical trials are under way to learn whether CBT also can help patients with Tourette’s syndrome, gambling addiction, obesity, irritable bowel syndrome and more; one trial studies the therapy in children who have been sexually abused.”

The Forbes article highlights patients who improved with CBT, and includes commentary from leaders in the field, including Dr. Aaron Beck.

Research Results: Having Trouble Sleeping? Experts Recommend CBT for Insomnia

The American Academy of Sleep Medicine recently published updated guidelines for treating Insomnia and recommended Cognitive Behavior Therapy (CBT) as an effective, evidence-based treatment. The Academy’s new guidelines are based on a large review of 37 sleep studies that examined the effectiveness of various treatments for 2,246 insomnia patients. This review showed that Cognitive Behavioral Therapy (CBT), among other behavioral/psychological interventions, is an effective treatment for insomnia, and that sleep improvements last over time.