Table 2.
Study periods | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Form | Baselinea | Enrolment | Allocation | Intervention (8 weeks) | Follow-up | |||||||
Timepoint | − T1 | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | |||
Time (month, weeks) | - max. 4 (w) | 0 (w) | 0 (w) | 2 (w) | 4 (w) | 6 (w) | 8 (w)/ 2 (m) | 6 (m) | 9 (m) | 12 (m) | ||
Patient information and informed consent | IC | x | ||||||||||
Allocation | x | |||||||||||
Demographics | TI | x | ||||||||||
In-/exclusion criteria | TI | x | ||||||||||
Lifetime and current diagnosis | TI | x | x | |||||||||
Social and role functioning | TI | x | x | |||||||||
Service use | TI | x | ||||||||||
Life events | TI | x | x | |||||||||
General psychopathology | OS | x | x | x | x | x | ||||||
Suicidality | OS | x | x | x | x | x | x | x | x | x | ||
Subclinical symptoms | OS | x | x | x | x | x | ||||||
Transdiagnostic mechanisms | OS | x | x | x | x | x | ||||||
Optional qualitative interview | TI | x | ||||||||||
Satisfaction with the intervention | OS | x | ||||||||||
Adherence | x | |||||||||||
Negative intervention effects | OS | x | ||||||||||
Working alliance | OS | x | x | x | x | |||||||
Therapy motivation | OS | x | x | x | x | x | ||||||
Adverse events and device deficiencies | OS/TI | x | x | x | x | x | x | x | x |
TI Telephone interview, OS Online survey, w Weeks, m Months
aBaseline assessments have been approved and conducted within the EMERGE study [100]