Table 1 Schedule of assessments
Screening | Treatment phase | Follow-up | Final visit | ||
|---|---|---|---|---|---|
Visit no: | 1 | 2 | 3 | 4 | 5 |
Screening and baseline assessment | 4-month follow-up | 8-month end-of-treatment follow-up | 11-month follow-up | 14-month (6 months post-treatment) follow-up | |
Window of flexibility for timing of visits: | n/a | + 2 months | + 3 months | + 2 months | + 3 months |
Informed consent | YES | ||||
Eligibility confirmation (CIS-R and DJG measures) | YES | ||||
Intervention credibility measure | YES | ||||
All outcome measures and service user information listed in s. 10.1 | YES | YES | YES | ||
Depression (PHQ-9) and Loneliness (ULS-8) measures only | YES | YES | YES | ||
Randomisation | YES | ||||
Trial intervention/treatment | YES | YES | |||
Adverse events active monitoring | YES | YES | YES | ||
Adverse events review | YES | YES | YES | YES | |
Withdrawal | YES | YES | YES | YES | YES |