Table 2.
Schedule of the assessments
| Enrolment | Baseline/randomisation | Intervention |
Follow-up |
||||
|---|---|---|---|---|---|---|---|
| Time point | −1 | 0 | 8 Weeks | 16 Weeks | After 3 months | After 6 months | After 12 months |
| Enrolment | |||||||
| Eligibility screen | X | ||||||
| Informed consent | X | ||||||
| Allocation | X | ||||||
| Interventions | |||||||
| CBT plus treatment as usual | ↔
|
||||||
| Treatment as usual | ↔
|
||||||
| Assessments | |||||||
| Demographics questionnaire | X | ||||||
| SCID-I | X | ||||||
| M.I.N.I. | X | ||||||
| SCID-II | X | ||||||
| GRID-HAMD | X | X | X | X | X | X | |
| BDI-II | X | X | X | X | X | X | |
| QIDS-SR16* | X | X | X | X | X | X | |
| EQ-5D | X | X | X | X | X | X | |
| SF-36 | X | X | X | X | X | X | |
| HPQ | X | X | X | X | X | X | |
*QIDS is also assessed at each visit during the intervention phase.
BDI-II, Beck Depression Inventory-Second Edition; CBT, cognitive behavioural therapy; EQ-5D, European Quality of Life Questionnaire–5 Dimensions; GRID-HAMD, GRID-Hamilton Depression Rating Scale; HPQ, WHO Health and Work Performance Questionnaire; M.I.N.I., Mini-International Neuropsychiatric Interview; QIDS-SR16, 16-item Quick Inventory of Depressive Symptomatology Self-Reported; SCID-I, Structured Clinical Interview for DSM-IV Axis I Disorders; SCID-II, Structured Clinical Interview for DSM-IV Axis II Disorders; SF-36, 36-Item Short-Form Health Survey.