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

1. Tai chi was inferior to cognitive behavioural therapy (CBT) for treating insomnia after the 3-month intervention, but was non-inferior 12 months post-intervention.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

Chronic insomnia is among the most common sleep disorders in middle-aged and older adults and has been linked with increased risk of cardiovascular diseases, mental disorders, cognitive impairment, and mortality. The first-line treatment for chronic insomnia is cognitive behavioural therapy for insomnia (CBT-I), but accessibility is often limited due to high costs and the low availability of trained therapists. A potential alternative insomnia treatment is tai chi, a form of mind-body exercise. Previous research has found tai chi to be beneficial for middle-aged and older adults with insomnia. However, it is unknown how tai chi directly compares with CBT-I in middle-aged and older adults with primary chronic insomnia. This study thus compared the acute and long-term efficacy of tai chi and CBT-I for treating chronic insomnia in middle-aged and older adults. This randomised non-inferiority trial enrolled participants aged ≥50 years with chronic insomnia in Hong Kong. The primary outcome was the change in perceived insomnia severity measured by the Insomnia Severity Index (lower score indicating lower severity). The margin of non-inferiority was a threshold of 4 points. Participants were randomly assigned 1:1 to either the tai chi group or CBT-I group. Each group underwent a 3-month intervention consisting of one-hour sessions twice a week for a total of 24 sessions. Out of the 200 participants randomised to receive tai chi or CBT-I, 166 (82 in the tai chi group and 84 in the CBT-I group) completed the assessments at month 3, and 167 (85 in the tai chi group and 82 in the CBT-I group) completed the assessments at month 15. At month 3, Insomnia Severity Index scores in the tai chi group decreased by 6.67, while those in the CBT-I group decreased by 11.19, resulting in a between-group difference of 4.52. Since the upper confidence limit exceeded the non-inferiority margin, tai chi was considered inferior to CBT-I at month 3. At month 15, Insomnia Severity Index scores in the tai chi group decreased by 9.5, while those in the CBT-I group decreased by 10.18, resulting in a between-group difference of 0.68. Since the upper confidence limit fell within the non-inferiority margin, tai chi was considered non-inferior to CBT-I at month 15. No adverse events were reported. Overall, this study found that tai chi was inferior to CBT-I after the 3-month intervention but was non-inferior 12 months post-intervention. 

Click to read the study in the BMJ 

Relevant reading: Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial

In-Depth [randomised non-inferiority trial]:

This trial enrolled participants aged ≥50 years with chronic insomnia from a single research site in Hong Kong between May 18th, 2020, and July 14th, 2022. Chronic insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition. The primary outcome was the change in perceived insomnia severity measured by the Insomnia Severity Index (lower score indicating lower severity) after the 3-month intervention and at the 12-month follow-up. The margin of non-inferiority was a threshold of 4 points. Participants were randomly assigned 1:1 to either the tai chi group or CBT-I group. Each group underwent a 3-month intervention consisting of one-hour sessions twice a week for a total of 24 sessions at the School of Public Health, University of Hong Kong. Each tai chi session consisted of 10 minutes of warm-up exercises, 45 minutes of Yang style tai chi practice, and five minutes of cool-down exercises. The CBT-I intervention included sleep education, stimulus control, sleep restriction, relaxation training, and cognitive therapy. Outcomes were assessed at baseline, after the intervention (month 3), and at the 12-month follow-up (month 5). In total, 200 participants were randomised to receive tai chi (n=100, mean [SD] age = 64.83 [6.31] years, female [%] = 77 [77]) or CBT-I (n=100, mean [SD] age = 63.76 [6.15] years, female [%] = 84 [84]). However, 166 (83%; 82 in the tai chi group and 84 in the CBT-I group) completed the assessments at month 3, and 167 (83.5%; 85 in the tai chi group and 82 in the CBT-I group) completed the assessments at month 15. At month 3, Insomnia Severity Index scores in the tai chi group decreased by 6.67 (95% confidence interval [CI] 5.61 to 7.73), while those in the CBT-I group decreased by 11.19 (95% CI 10.06 to 12.32), resulting in a between-group difference of 4.52 (95% CI −∞ to 5.81). Since the upper confidence limit exceeded the non-inferiority margin of 4, tai chi was considered inferior to CBT-I at month 3. At month 15, Insomnia Severity Index scores in the tai chi group decreased by 9.51 (95% CI 8.47 to 10.54), while those in the CBT-I group decreased by 10.18 (95% CI 8.97 to 11.40), resulting in a between-group difference of 0.68 (−∞ to 2.00). Since the upper confidence limit fell within the non-inferiority margin, tai chi was considered non-inferior to CBT-I at month 15. No adverse events were reported. Overall, this study found that tai chi was inferior to CBT-I after the 3-month intervention but was non-inferior 12 months post-intervention. These findings support tai chi as an alternative treatment for the long-term management of chronic insomnia in this population. Some limitations of this study include the large portion of the participants being older adults (>60 years) and the fact that the study was conducted at a single research centre, both of which may limit generalisability. Future longitudinal studies should validate study findings in other populations with different demographic characteristics.  

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