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Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer
Journal of Clinical Oncology, 10/02/08

Espie CA et al. – Cognitive behavior therapy (CBT) for insomnia may be both clinically effective and feasible

• Study of clinical effectiveness of protocol-driven CBT for insomnia, delivered by oncology nurses
• Randomized, controlled, pragmatic, 2-center trial of CBT vs treatment as usual (TAU) in 150 pts (103 females; mean age, 61 yrs) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer
• Primary outcomes: sleep diary measures at baseline, post-treatment, 6-mo follow-up
• Secondary measures: actigraphic sleep, health-related quality of life (QOL), psychopathology, fatigue
• CBT: 5, small-group sessions for consecutive weeks by manualized protocol
• TAU: normal clinical practice as appropriate control for a clinical effectiveness study

• CBT associated with mean reductions in wakefulness of 55min/night vs no change in TAU
• Outcomes sustained 6 mo after treatment
• Standardized relative effect sizes were large for: difficulty initiating sleep, waking from night sleep, sleep efficiency (% of bed time spent asleep)
• CBT associated with moderate to large effect sizes for 5 of 7 QOL outcomes, including significantly reduced daytime fatigue
• No significant interaction effect between any outcomes and baseline demographic, clinical, or sleep characteristics

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