Table 2.
SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials)
| Study period | |||||||
|---|---|---|---|---|---|---|---|
| Screening | Randomisation | Post-randomisation | |||||
| Timepoint | Pre-T0 | Pre-T0 | T0 | T0–T1 |
T1 + 6 weeks |
T2 + 24 weeks |
|
| Enrolment: | |||||||
| Eligibility screen | X | ||||||
| Referral to research team | X | ||||||
| Informed consent | X | ||||||
| Randomisation | X | ||||||
| Interventions: | X | ||||||
| Assessments: | |||||||
| PHQ-9 | X | X | X | X | |||
| Demographics information | X | ||||||
| GAD-7 | X | X | X | ||||
| WEMWBS | X | X | X | ||||
| R-COPE | X | X | X | ||||
| EQ-5D-5L | X | X | X | ||||
| CSRI | X | X | |||||
| Measure of loneliness | X | X | X | ||||
| Adherence | X | ||||||
| Focus groups | X | ||||||
| Adverse event monitoring | X | X | X | ||||
Note: T0 = baseline, T1 = first follow-up, T2 = second follow-up, PHQ-9 = Patient Health Questionnaire, GAD-7 = Generalized Anxiety Disorder, WEMWBS = The Warwick-Edinburgh Mental Wellbeing Scale, R-COPE = Brief Religious Coping Measure, CSRI = Client Service Receipt Inventory