Timeline | Baseline | Intervention | Post-treatment | ||||
---|---|---|---|---|---|---|---|
Enrolment | Pre-treatment assessment | Allocation | Treatment | Post-treatment assessment | 1-month follow-up | 6-month follow-up | |
Enrolment | |||||||
Screening for eligibility | ● | ||||||
Informed consent | ● | ||||||
Allocation | ● | ||||||
Intervention | |||||||
CBTI + BLT | ● | ● | ● | ● | ● | ||
CBTI-BLT | ● | ● | ● | ● | ● | ||
Waitlist Control | ● | ● | |||||
Data Collection | |||||||
Primary outcomes | ● | ● | ● | ● | |||
ISI | ● | ● | ● | ● | ● | ||
Secondary outcomes | ● | ● | ● | ● | |||
PSQI | ● | ● | ● | ● | |||
MCTQ | ● | ● | ● | ● | |||
CDRS | ● | ● | ● | ● | |||
HADS | ● | ● | ● | ● | ● | ||
DSI-SS | ● | ● | ● | ● | |||
PDSS | ● | ● | ● | ● | |||
MFI | ● | ● | ● | ● | |||
KIDSCREEN-27 | ● | ● | ● | ● | |||
Sleep diary parameters | ● | ● | ● | ● | ● | ||
Actigraphy parameters | ● | ● | ● | ● | |||
PSG parameters | ● | ● | |||||
DLMO assessment | ● | ● | |||||
Neurocognitive assessments | ● | ● | ● |