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Randomized Controlled Trial Comparative Study
Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial.
- Sheila N Garland, Linda E Carlson, Alisa J Stephens, Michael C Antle, Charles Samuels, and Tavis S Campbell.
- Sheila N. Garland, Abramson Cancer Center, University of Pennsylvania Health System, and Perelman School of Medicine; Alisa J. Stephens, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA; Sheila N. Garland, Linda E. Carlson, Michael C. Antle, Charles Samuels, and Tavis S. Campbell, University of Calgary, Calgary, Alberta, Canada.
- J. Clin. Oncol. 2014 Feb 10;32(5):449-57.
PurposeOur study examined 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.Patients And MethodsThis was a randomized, partially blinded, noninferiority trial involving patients with cancer with insomnia recruited from a tertiary cancer center in Calgary, Alberta, Canada, from September 2008 to March 2011. Assessments were conducted at baseline, after the program, and after 3 months of follow-up. The noninferiority margin was 4 points measured by the Insomnia Severity Index. Sleep diaries and actigraphy measured sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency. Secondary outcomes included sleep quality, sleep beliefs, mood, and stress.ResultsOf 327 patients screened, 111 were randomly assigned (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 SOL was reduced by 22 minutes in the CBT-I group and by 14 minutes in the MBSR group at follow-up. Similar reductions in WASO were observed for both groups. TST 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).ConclusionAlthough 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.
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