| | 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
