Brief CBT-I Improves Insomnia During Breast Cancer Chemotherapy: JAMA

In order to properly assess sleep and fatigue outcomes, a 6-week, 2x2 factorial, parallel group randomized clinical trial was carried out over five metropolitan and regional hospitals in Australia between January 22, 2021 and August 21, 2024. The study involved prospective recruitment of 219 women over 18 years of age with early or metastatic breast cancer undergoing active chemotherapy treatment. Subjects were randomized into four intervention arms including CBT-I only (n=55), BLT only using light glasses providing 1,500 lux (n=55), CBT-I combined with BLT (n=52) and SHE control (n=57).

All interventions were six weeks in duration and included a single one-on-one consultation session, weekly emails and a midway telephone contact. The primary outcomes measured were change from baseline of ISI score and PROMIS-Fatigue T-score up to six months after completion of the interventions.

Key findings:

• Participants in the CBT-I groups achieved significant reductions in insomnia symptoms compared to non–CBT-I groups (ISI score mean difference [MD], −2.19 points; 95% CI, −3.33 to −1.05; P = .002).
• CBT-I did not produce statistically significant improvements in fatigue symptoms compared to non–CBT-I interventions (PROMIS-Fatigue score MD, −0.90 points; 95% CI, −3.08 to 1.28; P = .52).
• Across the general cohort, BLT groups showed no statistically significant differences versus non-BLT groups in insomnia (ISI MD, −0.88 points; 95% CI, −2.02 to 0.26; P = .26) or fatigue symptoms (PROMIS-Fatigue MD, −0.71 points; 95% CI, −2.89 to 1.47; P = .52).
• In an exploratory subgroup analysis of 54 women with metastatic breast cancer, BLT significantly improved both insomnia symptoms (ISI MD, −2.87 points; 95% CI, −5.06 to −0.67; P = .01) and fatigue symptoms (PROMIS-Fatigue MD, −5.16 points; 95% CI, −9.57 to −0.76; P = .02).

In summary, the SleepCARE trial proves that CBT-I treatment for six weeks during chemotherapy treatment in women with breast cancer decreases symptoms of insomnia when compared with sleep hygiene education or bright light therapy interventions. While the use of CBT-I did not have an effect on cancer-related fatigue among the whole population studied, its proven effectiveness against sleep disturbances gives great justification for its clinical use.

Reference:

Do TT, Maccora J, Wallace R, et al. Cognitive Behavior vs Bright Light Therapy for Insomnia in Women Undergoing Chemotherapy for Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2026;9(8):e2630320. doi:10.1001/jamanetworkopen.2026.30320