Screening and baseline | Randomisation | 13-week follow-up | 26-week follow-up | |
---|---|---|---|---|
Time point (weeks) | 0 | 0 | 13 ± 2 | 26 ± 2 |
Procedures: | ||||
Consent, eligibility screening and confirmation | ||||
Written and Informed consent | X | |||
Assess eligibility | X | |||
Confirm eligibility | X | |||
Randomisation | X | |||
Confirm consent | X | X | X | |
Data collection | ||||
HADS | X | X | X | |
WHODAS | X | X | X | |
PHQ-9 | X | X | X | |
PSYCHLOPS | X | X | X | |
PCL-5 | X | X | X | |
WHO-5 | X | X | X | |
CSRI | X | X | X | |
Adverse events | ||||
Assessment of AEs | X | X | X |