Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment | Allocation | |||||||
Visit No./timepoint | SCR I −t2 | SCR II −t1 | t0 | FASTER or SCOTT&EVA | t1 | t2 | ||
Procedure | Screening | Treatment phase | Follow-up phase | |||||
Month | −2 | −1 | 0 | Randomization | 1–4 | 4 | 5–8 | 8 |
Inclusion/exclusion criteria 1 | ● | |||||||
Inclusion/exclusion criteria 2 | ● | |||||||
Written informed consent | ● | |||||||
Baseline (T0) | ● | |||||||
Interventions | TF/S | |||||||
Post-treatment measurement (T1) | ● | |||||||
Booster Sessions for treatments | BF/S | |||||||
Follow-up measurement (T2) | ● | |||||||
AE/SAE | ● | ● | ● | ● | ● | |||
Psychopharmacotherapy | ● | ● | ● | ● | ● | ● | ● |