Raw data for the project

<b>Objective</b>Access to cognitive behavioral therapy for insomnia (CBT-I), the first-line treatment for chronic insomnia, is often limited; therefore, this study validated Tai Chi as a non-inferior alternative for managing chronic insomnia in middle-aged and older adults.<b>Design</b>This randomized, assessor-blinded, non-inferiority trial recruited 200 middle-aged and older adults with chronic insomnia in Hong Kong between 18 May 2020 and 14 July 2022. Assessments were conducted at baseline, post-intervention (month 3), and 12-month post-intervention follow-up (month 15).<b>Setting</b>A single research site in Hong Kong with participants recruited from the local community.<b>Participants</b>Chinese participants who aged ≥50 years with chronic insomnia diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.<b>Interventions</b>Both Tai Chi and CBT-I interventions were delivered in group format over 3 months, consisting of two 1-hour sessions per week, for a total of 24 sessions.<b>Main outcome measures</b>The primary outcome was the change in perceived insomnia severity measured by the Insomnia Severity Index (ISI) at month 3 and 15. An ISI of 4 points was adopted as the margin to assess non-inferiority.<b>Results</b>A total of 200 participants were randomized (1:1) to receive Tai Chi (n=100) or CBT-I (n=100) intervention. The per-protocol (PP) principle was adopted. At month 3, the Tai Chi group showed a reduction of 6.67 (95% CI: 5.61 to 7.73) in ISI scores, while the CBT-I group had a reduction of 11.19 (95% CI: 10.06 to 12.32), resulting in a between-group difference of 4.52 (95% CI: -∞ to 5.81). Tai Chi was deemed inferior to CBT-I at month 3, as the upper 95% CI exceeded the non-inferiority margin. At month 15, the reductions for Tai Chi and CBT-I were 9.51 (95% CI: 8.47 to 10.54) and 10.18 (95% CI: 8.97 to 11.40), respectively, with a between-group difference of 0.68 (95% CI: -∞ to 2.00). At this point, Tai Chi was considered non-inferior to CBT-I, as the upper 95% CI fell within the non-inferiority margin. Results from the intention-to-treat analysis were consistent with the PP findings. No adverse events occurred during the intervention period.<b>Conclusion</b>Tai Chi was inferior to CBT-I at month 3 but non-inferior at month 15. This finding supports the use of Tai Chi as an alternative approach for the long-term management of chronic insomnia in older adults.