Time point | 0 | 0 | 1 | 2 | 4 | Completed by |
---|---|---|---|---|---|---|
Months post randomisation | Pre-baseline/screening | Baseline | Mid-treatment (4 weeks) | Complete-treatment (8 weeks) | 8 weeks after completion (16 weeks) | |
Consent | X | Â | Â | Â | Â | P |
GAD7 | Â | X | X | X | X | R and P |
WSAS | Â | X | X | X | X | R and P |
EQ-5D-5L | Â | X | X | X | X | R and P |
CSRI | Â | X | X | X | X | R and P |
SCID-5-RV | X (major depressive episode criteria) | X | Â | Â | Â | R and P |
GRID-HAMD | Â | X | X | X | X (primary outcome) | R and P |
Randomisation | Â | X | Â | Â | Â | R |
PHQ-9 | X | Â | X | X | X | R and P |