Table 2. Characteristics of Included Patients and Trials.
| Value | No. | |
|---|---|---|
| Patient characteristics | ||
| Age, mean (SD), y | 45.4 (16.6) | 236 Trials |
| Sex, No. (%) | ||
| Female | 21 048/31 452 (67) | 232 Trials |
| Male | 10 404/31 452 (33) | |
| Hypnotic use, No. (%) | 4259/20 704 (21) | 167 Trials |
| Comorbidities, type | Primary insomnia | 60 Trials |
| Psychotic comorbidities | 42 Trials | |
| Physical comorbidities | 75 Trials | |
| Mixed | 64 Trials | |
| Baseline severity (ISI score), mean (SD) | 16.8 (4.8) | 163 Trials |
| Diagnosis | Formal operationalized criteria | 146 Trials |
| Elevated score | 70 Trials | |
| Others | 25 Trials | |
| Trial characteristics | ||
| Region | North America | 120 Trials |
| Europe | 61 Trials | |
| Asia | 34 Trials | |
| Oceania | 14 Trials | |
| Middle East | 8 Trials | |
| South America | 3 Trials | |
| Africa | 1 Trial | |
| No. of arms | 2 | 206 Trials |
| 3 | 26 Trials | |
| 4 | 7 Trials | |
| 5 | 1 Trial | |
| 6 | 1 Trial | |
| Randomization unit | Individual | 224 Trials |
| Cluster | 2 Trials | |
| Publication year, mean (range) | 2015 (1980-2023) | 241 Trials |
| Intervention | Total | 528 Arms |
| Treatment level | Cognitive behavioral therapy | 210 Arms |
| Behavioral therapy | 64 Arms | |
| Cognitive therapy | 17 Arms | |
| Relaxation therapy | 16 Arms | |
| Psychoeducation | 105 Arms | |
| Attention or psychological placebo | 5 Arms | |
| Treatment as usual | 8 Arms | |
| No treatment | 5 Arms | |
| Waiting list | 98 Arms | |
| Components | ||
| Educational components | Sleep hygiene education | 324 Arms |
| Sleep diary | 433 Arms | |
| Cognitive components | Cognitive restructuring | 203 Arms |
| Third-wave components | 58 Arms | |
| Constructive worry | 21 Arms | |
| Behavioral components | Sleep restriction | 244 Arms |
| Stimulus control | 249 Arms | |
| Paradoxical intention | 20 Arms | |
| Relaxation | 174 Arms | |
| Others | Nonspecific treatment effect | 423 Arms |
| Waiting component | 102 Arms | |
| Delivery methods | Individual | 228 Arms |
| Group | 100 Arms | |
| In person | 287 Arms | |
| Online therapeutic guidance | 39 Arms | |
| Human encouragement | 49 Arms | |
| Automatic encouragement | 41 Arms |
Abbreviation: ISI, Insomnia Severity Index.