Table 3.

Schedule of measure administration

	Screening		Study visits
Measures	Survey, phone interview	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6	Visit 7
Screening and baseline measures
Written consent, eligibility confirmation		X
Demographics	X	X
Vision screening		X
Height and weight		X
Breathalyzer		X	X	X	X	X	X	X
Urine drug test		X
Medical history, medications	X	X
Restless legs (CHQ, sIRLS)			X
Clinician-administered measures
HBI for CD				X				X
SCCAI for UC				X				X
Self-report measures
SIBDQ (primary outcome)	X			X				X
PHQ-9				X				X
PROMIS Sleep Disturbance 8b				X				X
Morningness-Eveningness Questionnaire				X				X
Daily logs (sleep & events)			X	X	X	X	X	X
Treatment Expectation				X
Treatment Satisfaction								X
Objective measures
Wrist actigraphy			X	X	X	X	X	X
Fecal calprotectin				X				X
Safety measures
BDI			X	X	X	X	X	X
C-SSRS (past 6 months)		X
C-SSRS (since last visit)			X	X	X	X	X	X
SAFTEE					X	X	X	X