Table 3 Summary of findings on the effects of CBT-I on End-of-Intervention primary and secondary outcomes

ISI

MD 4.4 points lower

(5.3 lower to 3.5 lower)

1195

(16 RCTs)

⨁⨁◯◯

Low^{a, b}

On average, did not reach the MCID threshold of ≥ 6 points [24, 33], but reached half of the MIC, suggesting an appreciable number, not many, of participants derived clinically-important benefit.

Fatigue

SMD 0.29 lower

(0.43 lower to 0.15 lower)

831

(11 RCTs)

⨁⨁◯◯

Low^{c, d,e}

Statistically small effect size of unclear or no clinical meaningfulness (i.e., on average, did not reach the recommended SMD threshold ≥ 0.50 to suggest clinical meaningfulness) [36, 37].

HRQL

SMD 0.2 higher

(0.04 higher to 0.36 higher)

626

(10 RCTs)

⨁◯◯◯

Very low^{d, e}

Small effect size of unclear or no clinical meaningfulness (i.e., on average, did not reach the recommended SMD threshold ≥ 0.50 to suggest clinical meaningfulness) [36, 37].

Sleep Diary

Sleep Latency

MD 11.5 min lower

(15.1 lower to 7.9 lower)

936

(12 RCTs)

⨁⨁◯◯

Low [64]^,f

On average, did not reach the MCID threshold of 20 min [36, 37], but reached half of the MIC, suggesting an appreciable number, not many, of participants derived clinically-important benefit.

Sleep Diary

Sleep Duration

MD 4.5 min higher

(6.9 lower to 15.9 higher)

974

(12 RCTs)

⨁◯◯◯

Very low^{a, f,g}

Not statistically significant and did not reach the MCID threshold of 30 min [36, 37] nor half of the MIC to suggest clinical-important benefit.

Sleep Diary

WASO

MD minutes 14.7 lower

(20.8 lower to 8.5 lower)

937

(12 RCTs)

⨁⨁◯◯

Low^{a, f}

On average, did not reach the MCID threshold (including the 95% CI) of 30 min [36, 37], but reached close to half of the MIC, suggesting an appreciable number, not many, of participants derived clinically-important benefit.

Sleep Diary

Sleep Efficiency

MD 7.0% higher

(5.2 higher to 8.7 higher)

994

(13 RCTs)

⨁◯◯◯

Very low^{a, b,f}

On average, did not reach the MCID threshold (including the 95% CI) of 10% [36, 37], but reached half of the MIC, suggesting that an appreciable number, not many, of participants derived clinically-important benefit.