Garland, S.N., Carlson, L.E., Stephens, A.J., Antle, M.C., Samuels, C., & Campbell, T.S. (2014). Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: A randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 32, 449–457. 

To examine whether mindfulness-based stress reduction (MBSR) is noninferior to cognitive behavioral therapy for insomnia (CBT-I) for the treatment of insomnia in patients with cancer

• N = 111  
• MEAN AGE = 58.89 years (SD = 11.08 years)
• AGE RANGE = 35–88 years
• MALES: 28%, FEMALES: 72%
• KEY DISEASE CHARACTERISTICS: Patients with mixed nonmetastatic cancer who had insomnia and completed primary treatment at least one month prior; 48% had breast cancer, and 12% had prostate cancer; mean cancer duration was 3.9 years (SD = 4.03 years); treatments included surgery, chemotherapy, radiation, and hormonal therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Mean education was 15.14 years (SD = 3.53 years); 90% white/European

• SITE: Single site    
• SETTING TYPE: Tertiary cancer center    
• LOCATION: Calgary, Canada

• PHASE OF CARE: Long-term survivorship (at least one month since active, primary treatment)

• Randomized, partially blinded, noninferiority trail

• Insomnia Severity Index (ISI)
• Daily sleep diaries
• Actigraph GT1M
• Calgary Symptoms of Stress Inventory
• Profile of Mood States (POMS)
• Dysfunctional Beliefs and Attitude About Sleep (DBAS)

Of 327 patients screened, 111 were assigned randomly (CBT-I, n = 47; MBSR, n = 64). MBSR was inferior to CBT-I for improving insomnia severity immediately after the program (p = .35), but MBSR demonstrated noninferiority at follow-up (p = .02). Sleep diary-measured sleep latency (minutes to fall asleep) was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up. Similar reductions in wake after sleep onset (in minutes) were observed for both groups. Total sleep time increased by 0.60 hours for CBT-I and 0.75 hours for MBSR. CBT-I improved sleep quality (p = .001) and dysfunctional sleep beliefs (p = .001), whereas both groups experienced reduced stress (p = .001) and mood disturbance (p = .001).

Although MBSR produced a clinically significant change in sleep and psychological outcomes, CBT-I was associated with rapid and durable improvement and remains the best choice for the nonpharmacologic treatment of insomnia.

• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Other limitations/explanation: The most notable limitation is the differential attrition observed between groups. Although the reasons are unknown, participant preference may have contributed to the significant attrition in the MBSR group compared with CBT-I because how learning meditation and yoga could contribute to sleep improvements may be less obvious to participants not already inclined to choose MBSR. The findings are not generalizable to a more racially diverse population (90% white/European). The absence of a no-treatment control group prevents an exploration of alternate explanations for change over time. The additional six hours of contact time received by participants in the MBSR group raises the possibility of even greater relative improvement for the CBT-I group if it had been matched for time. Treatment integrity was not formally assessed; however, the research was designed to minimize risk of treatment contamination, and measures were taken throughout the study to promote fidelity.

Noninferiority of MBSR only was demonstrated at the five-month follow-up, suggesting that although MBSR may produce clinically significant improvements with time, the treatment effects of CBT-I are rapid and durable. Thus, CBT-I remains the treatment of choice for patients with cancer who have insomnia.