A non-inferiority randomized controlled trial comparing a home-based aerobic exercise program to a self-administered cognitive-behavioral therapy for insomnia in cancer patients

Abstract

Study Objectives: Thirty to sixty percent of cancer patients have insomnia symptoms, a condition which may lead to numerous negative consequences and for which an efficacious management is required. This randomized controlled trial aimed to assess the efficacy of a 6-week home-based aerobic exercise program (EX) compared to that of a 6-week self-administered cognitive-behavioral therapy for insomnia (CBT-I) to improve sleep in cancer patients. Method: Forty-one patients (78.1% female, mean age 57 years) with various types of cancer and having insomnia symptoms (Insomnia Severity Index [ISI] score ≥ 8) were randomized to the EX (n = 20) or the CBT-I (n = 21) groups. Measures were completed at pretreatment and posttreatment, as well as at 3- and 6-month follow-ups. Results: The EX intervention was statistically inferior to CBT-I in reducing ISI scores at posttreatment but was non-inferior at follow-up. However, no significant group-by-time interaction was found on any outcome and both interventions led to a significant improvement of subjectively-assessed sleep impairments on the ISI, the Pittsburgh Sleep Quality Index (PSQI) and most sleep parameters from a daily sleep diary at posttreatment corresponding to medium to large time effects (ds > 0.50 for ISI, PSQI, sleep onset latency, wake after sleep onset, total wake time and sleep efficiency). Conclusion: Both interventions produced significant improvements of sleep. However, EX was found to be significantly inferior to CBT-I in reducing ISI scores at posttreatment, which contradicts the initial non-inferiority hypothesis. These findings suggest that CBT-I remains the treatment of choice for cancer-related insomnia, although EX can lead to some beneficial effects. ClinicalTrials.gov Identifier: NCT02774369 https://clinicaltrials.gov/ct2/show/NCT02774369?term=NCT02774369&rank=1.

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