| 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 |
- Abbreviations: AEs adverse events, CSRI Client Service Receipt Inventory, HADS Hospital Anxiety and Depression Scale, PCL-5 Post-traumatic Stress Disorder Checklist for DSM-5, PHQ-9 9-item Patient Health Questionnaire, PSYCHLOPS Psychological Profiles Instrument,, WHO-5 World Health Organisation Five Wellbeing Index, WHODAS World Health Organisation Disability Assessment Schedule