Tai chi or cognitive behavioural therapy for treating insomnia in middle aged and older adults: randomised non-inferiority trial.

Methods

Randomised, assessor masked, non-inferiority trial.

随机、评估者盲法、非劣效性试验。

A single research site in Hong Kong with participants recruited from the local community between 18 May 2020 and 14 July 2022.

一个位于香港的研究地点，招募了来自当地社区的参与者，招募时间为2020年5月18日至2022年7月14日。

Chinese participants aged ≥50 years with chronic insomnia diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition.

根据《精神疾病诊断与统计手册》第五版诊断的，年龄≥50岁的中国慢性失眠患者。

Tai chi and CBT-I interventions were delivered in group format over three months, consisting of one hour sessions twice a week for a total of 24 sessions.

太极拳和认知行为疗法干预（CBT-I）以小组形式进行，为期三个月，每周两次，每次一小时，总共进行24次课程。

The primary outcome was the change in perceived insomnia severity measured by the Insomnia Severity Index after the intervention (month 3) and at 12 month follow-up (month 15).

主要结果是干预后（第3个月）和随访12个月（第15个月）通过失眠严重程度指数测量的感知失眠严重程度的变化。

To assess whether tai chi is non-inferior to CBT-I, a threshold of four points was used as the margin of non-inferiority.

为了评估太极是否不劣于认知行为治疗失眠（CBT-I），使用了四分作为非劣效性的界限。

Results

200 participants were randomised (1:1) to receive tai chi (n=100) or CBT-I (n=100).

200名参与者被随机分配（1:1），分别接受太极（n=100）或CBT-I（n=100）。

The per protocol principle was adopted.

采用了按方案分析原则。

At month 3, the tai chi group showed a reduction of 6.67 (95% confidence interval5.61 to 7.73) in Insomnia Severity Index scores, while the CBT-I group had a reduction of 11.19 (10.06 to 12.32), resulting in a between group difference of 4.52 (-∞ to 5.81).

在第3个月时，太极拳组在失眠严重指数评分上显示出6.67分（95%置信区间5.61至7.73）的降低，而认知行为治疗失眠（CBT-I）组的降低为11.19分（10.06至12.32），两组之间的差异为4.52分（负无穷至5.81）。

Tai chi was deemed inferior to CBT-I at month 3 because the upper confidence limit exceeded the non-inferiority margin.

在第3个月时，由于置信区间的上限超过了非劣效性界限，太极拳被认为不如CBT-I。

At month 15, the reductions for tai chi and CBT-I were 9.51 (8.47 to 10.54) and 10.18 (8.97 to 11.40), respectively, with a between group difference of 0.68 (-∞ to 2.00).

在第15个月时，太极拳和CBT-I的减少量分别为9.51（8.47至10.54）和10.18（8.97至11.40），两组之间的差异为0.68（负无穷至2.00）。

At this point, tai chi was considered non-inferior to CBT-I because the upper confidence limit fell within the non-inferiority margin.

在这一点上，太极拳被认为不劣于CBT-I，因为上置信限落在非劣效性边界内。

Results from the intention-to-treatanalysis were consistent with the per protocol findings.

意向治疗分析的结果与按方案分析的结果一致。

No adverse events occurred during the intervention period.

干预期间没有发生不良事件。

Conclusions

Tai chi was inferior to CBT-I at month 3 but non-inferior at month 15.

在第3个月时，太极的效果不如CBT-I，但在第15个月时，太极的效果与CBT-I相当。

This finding supports the use of tai chi as an alternative approach for the long term management of chronic insomnia in middle aged and older adults.

这一发现支持将太极拳作为一种替代方法，用于中老年人慢性失眠的长期管理。

trial_registration

ClinicalTrials.gov NCT04384822.

ClinicalTrials.gov NCT04384822。