Table 2.
Study schedule and assessments
Outcome measures | Baseline assessment (consent to the study) | Baseline MRI scan |
Treatment Monday–Friday for 4–6 weeks | 8 weeks follow-up assessment | 16 weeks follow-up assessment | 16 weeks MRI scan | 26 weeks follow-up assessment |
Visit window | Within 14 days of Baseline Assessment | +14 days of MRI Scan | ±1 week from Randomisation | ±1 week from Randomisation | Within 14 days of 16 week Follow-up Assessment | ±1 week from randomisation |
|
HDRS-17 | ✓ | ✓Only if baseline assessment exceeds 4 weeks | ✓ | ✓ | ✓ | ||
MGH | ✓ | ✓ Only if Baseline assessment exceeds 4 weeks | |||||
BDI-II | ✓ | ✓ | ✓ | ✓ | |||
PHQ-9 | ✓ | ✓ | ✓ | ✓ | |||
WSAS | ✓ | ✓ | ✓ | ✓ | |||
GAD7 | ✓ | ✓ | ✓ | ✓ | |||
EQ-5D-5L | ✓ | ✓ | ✓ | ✓ | |||
THINC-it | ✓ | ✓ | ✓ | ✓ | |||
SCID-5 | ✓ | ||||||
CTQ | ✓ | ||||||
QIDS-SR | ✓ | ✓ | ✓ | ✓ | |||
Client Resource Questionnaire | ✓ | ✓ | ✓ | ||||
Patient Acceptability | ✓ | ✓ | ✓ | ✓ | |||
Side effects checklist (adverse events) | ✓ | ✓ | |||||
fMRI | ✓ | ✓ | |||||
MRI | ✓ | ✓ | |||||
rsfMRI | ✓ | ✓ | |||||
MRS | ✓ | ✓ | |||||
Diffusion-weighted imaging | ✓ | ✓ |
BDI-II, Beck Depression Inventory-II; CTQ, Childhood Trauma Questionnaire; EQ-5D-5L, EuroQoL-five-Dimensions-5-Level; GAD-7, Generalised Anxiety Disorder-7; HDRS-17, Hamilton Depression Rating Scale-17; MGH, Massachusetts General Hospital; MRS, MR spectroscopy; QIDS-SR, Quick Inventory of Depressive Symptomatology; rsfMRI, resting state functional MRI; SCID-5, Structured Clinical Interview-5; THINC-it, THINC-Integrated Tool; WSAS, Work and Social Adjustment Scale.