Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

Total score (0-28): no insomnia (0-7); sub-threshold (8-14); moderate (15-21); and severe insomnia (22-28). A reduction pre- to post-treatment/follow-up of 8 points (or more) indicate a treatment response and a post-treatment/follow-up score or 7 (or less) indicate remission.

Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12)

Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24)

Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24)

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors:

Sleep Onset Latency (SOL) is the subjective estimate of time it takes to fall asleep after going to bed and turning the lights out (or attempting to go to sleep). SOL is measured in minutes (lower values are better).

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors:

Wake After Sleep Onset (WASO) is the subjective estimate of time awake in the middle of the night, after falling asleep and before final rise time/out of bed. WASO is measured in minutes (lower values are better).

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors:

Sleep Efficiency (SE) = (total sleep time [TST] / time in bed [TIB]) x 100. SE is measured as a percentage (range 0-100%; higher values are better).

Includes constructs of Physical Function, Participation in Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference and Intensity, and Cognitive Function. Constructs are scored individually (4 items, 4-20) except Cognitive Function (2 items, 2-10).

T-score: population mean=50 and a standard deviation=10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, Depression, Sleep, Pain, and Fatigue, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function, Cognitive Function, and Social Roles, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.

When all constructs are scored together, a preference score is calculated, representing health-related quality of life ranging from 0 (as bad as dead) to 1 (perfect or ideal health).

The PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a preference score (PROMIS Preference, PROPr). Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Scores can be used in comparisons across groups and for cost-utility analyses. The profile includes all items in the PROMIS-29 Profile v2.1 plus two Cognitive Function Abilities items. T-scores from the measure can be used to calculate a preference-based score.