Table 3.
Summary of outcomes and clinical significance thresholds.
| Outcome and Tool | Critical Outcome | Clinical Significance Thresholds | Desired Direction Posttreatment Difference | |
|---|---|---|---|---|
| Intervention vs Control (Differences) | Delivery Method vs Delivery Method (Differences) | |||
| Sleep qualitya | ||||
| Diary | Yes | 0.5 SMD | 0.5 SMD* | Higher |
| PSQI | 0.5 SMD | 0.5 SMD* | Lower | |
| Sleep latency | ||||
| Diary | Yes | 20 min | 10 min | Lower |
| PSG | 20 min | 10 min | Lower | |
| WASO | ||||
| Diary | Yes | 20 min | 15 min | Lower |
| Actigraphy | 20 min | 15 min | Lower | |
| PSG | 20 min | 15 min | Lower | |
| Remission rateb | ||||
| ISI | Yes | ≥ 10% patients with < 8 points | ≥ 10% patients with < 8 points | Higher |
| Diary | Yes | ≥ 10% patients with < 31 min sleep latency and/or WASO | 10% patients with < 31 min sleep latency and/or WASO | Higher |
| PSQI | Yes | ≥ 10% patients with ≥ 5 points | ≥ 10% patients with ≥ 5 points | Higher |
| Responder rateb | ||||
| ISI | Yes | ≥ 10% patients with ≥ 8-point drop | ≥ 10% patients with ≥ 8-point drop | Higher |
| Diary | Yes | ≥ 10% patients with ≥ 0.5 SD improvement over baseline sleep latency and/or WASO | ≥ 10% patients with ≥ 0.5 SD improvement over baseline sleep latency and/or WASO | Higher |
| Total wake time | ||||
| Diary | 30 min | 20 min | Lower | |
| Actigraphy | 30 min | 20 min | Lower | |
| PSG | 30 min | 20 min | Lower | |
| Nights with hypnotic use | ||||
| Diary | 2 nights/wk | 2 nights/wk | Lower | |
| Total sleep time | ||||
| Diary | 15 min | 15 min | Higher | |
| Actigraphy | 15 min | 15 min | Higher | |
| PSG | 15 min | 15 min | Higher | |
| Number of nighttime awakenings | ||||
| Diary | 0.5 awakenings/night | 0.5 awakenings/night | Lower | |
| Sleep efficiency (%) | ||||
| Diary | 10 | 5 | Higher | |
| Actigraphy | 10 | 5 | Higher | |
| PSG | 10 | 5 | Higher | |
| Beliefs and attitudes about sleep | ||||
| DBASc | 0.5 SMD | 0.5 SMD | Lower | |
| Daytime fatigue domain | ||||
| All fatigue-specific toolsd | 0.5 SMD | 0.5 SMD | Lower | |
| Insomnia severity | ||||
| ISI | 0.5 SMD | 0.5 SMD | Lower | |
| ISQ | 0.5 SMD | 0.5 SMD | Lower | |
The order of outcomes in the table does not reflect relative weight or importance assigned to the outcomes. aTools to assess sleep quality: daily sleep diary (higher scores indicate higher sleep quality) and PSQI (higher scores indicate worse sleep quality). bClinical cutoff of ≤ 8 indicating no insomnia, PSQI with a clinical cutoff of ≤ 5 indicating normative sleep quality. The task force considered remission and responder rates as the most influential critical outcomes. cHigher scores reflect greater dysfunctional beliefs about sleep. dDaytime fatigue tools (all grouped together): Fatigue Severity Scale, Multidimensional Fatigue Inventory, Profile of Mood States Fatigue subscale, Fatigue Symptom Index, and Flinders Fatigue Scale. For all scales, higher scores indicate greater fatigue. *For SMD, an effect size of 0.5 was considered clinically significant (based on Hedge’s G). DBAS = Dysfunctional Beliefs and Attitudes About Sleep, ISI = Insomnia Severity Index, ISQ = Insomnia Severity Questionnaire, PSG = polysomnography, PSQI = Pittsburgh Sleep Quality Index, SD = standard deviation, SMD = standardized mean difference, WASO = wake after sleep onset.