TY - JOUR
T1 - Web-based cognitive-behavioral therapy for insomnia in cancer survivors
T2 - The OncoSleep randomized trial
AU - Clara, Maria I.
AU - van Straten, Annemieke
AU - Savard, Josée
AU - Canavarro, Maria C.
AU - Allen Gomes, Ana
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/5
Y1 - 2025/5
N2 - Purpose: Insomnia is highly prevalent among cancer survivors and can have serious implications if inadequately treated. Cognitive-behavioral therapy for Insomnia (CBT-I) is recommended as the first-line treatment for insomnia but is rarely available to cancer survivors. We tested the effectiveness of a web-based CBT-I program, OncoSleep, in cancer survivors. Methods: Cancer survivors with insomnia (n = 154) were randomly assigned (1:1) to digital CBT-I (6 weekly self-guided modules plus online clinician support) or a waitlist control group. Patient-reported outcome measures of insomnia severity (primary outcome), daytime functioning, and sleep diaries were administered online at baseline and post-treatment (8 weeks). Intention-to-treat analyses were performed using mixed-effects models. Statistical tests were two-sided. Results: The treatment group reported an average 11.0-point reduction in the Insomnia Severity index (ISI), compared to a 1.4-point reduction in the control group (p<.001). Statistically significant group-by-time interactions were observed: web-based CBT-I produced significant, large effects for improvements in insomnia severity (d = −2.56), cognitive functioning (d = 0.95), physical (d = 1.24) and psychological quality of life (d = 0.80), and fatigue (d = −1.35). Small-to-large effect sizes were found for reductions in anxiety (d = −0.77), depression (d = −0.71), and pain (d = −0.40). Change in insomnia severity mediated the effect of digital CBT-I on daytime outcomes. Conclusions: Web-based CBT-I with clinician support appears to be an effective treatment for insomnia in cancer survivors, offering meaningful benefits for comorbid symptoms and quality of life. Further studies with active comparisons and longer follow-up periods are needed to confirm these findings. Digital CBT-I could be integrated into cancer rehabilitation programs to reduce the burden of insomnia. [ClinicalTrials.gov: NCT04898855].
AB - Purpose: Insomnia is highly prevalent among cancer survivors and can have serious implications if inadequately treated. Cognitive-behavioral therapy for Insomnia (CBT-I) is recommended as the first-line treatment for insomnia but is rarely available to cancer survivors. We tested the effectiveness of a web-based CBT-I program, OncoSleep, in cancer survivors. Methods: Cancer survivors with insomnia (n = 154) were randomly assigned (1:1) to digital CBT-I (6 weekly self-guided modules plus online clinician support) or a waitlist control group. Patient-reported outcome measures of insomnia severity (primary outcome), daytime functioning, and sleep diaries were administered online at baseline and post-treatment (8 weeks). Intention-to-treat analyses were performed using mixed-effects models. Statistical tests were two-sided. Results: The treatment group reported an average 11.0-point reduction in the Insomnia Severity index (ISI), compared to a 1.4-point reduction in the control group (p<.001). Statistically significant group-by-time interactions were observed: web-based CBT-I produced significant, large effects for improvements in insomnia severity (d = −2.56), cognitive functioning (d = 0.95), physical (d = 1.24) and psychological quality of life (d = 0.80), and fatigue (d = −1.35). Small-to-large effect sizes were found for reductions in anxiety (d = −0.77), depression (d = −0.71), and pain (d = −0.40). Change in insomnia severity mediated the effect of digital CBT-I on daytime outcomes. Conclusions: Web-based CBT-I with clinician support appears to be an effective treatment for insomnia in cancer survivors, offering meaningful benefits for comorbid symptoms and quality of life. Further studies with active comparisons and longer follow-up periods are needed to confirm these findings. Digital CBT-I could be integrated into cancer rehabilitation programs to reduce the burden of insomnia. [ClinicalTrials.gov: NCT04898855].
KW - Cancer
KW - Digital cognitive-behavioral therapy for insomnia
KW - Digital health
KW - Internet intervention
KW - Randomized controlled trial
KW - Sleep disturbance
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U2 - 10.1016/j.sleep.2025.02.021
DO - 10.1016/j.sleep.2025.02.021
M3 - Article
AN - SCOPUS:85218249992
SN - 1389-9457
VL - 129
SP - 67
EP - 74
JO - Sleep Medicine
JF - Sleep Medicine
ER -