Table 1 Primary and secondary outcome measures for all participants from weeks 0 to 24
Evaluations | Enrol-ment | Randomisation/Interventions | Follow-ups | |||
|---|---|---|---|---|---|---|
Week 0 | Week 1 | Week 4 | Week 8 | Week 12 | Week 24 | |
Assessment of eligibility | ✓ | |||||
Informed Consent | ✓ | |||||
Heart rate variability, Blood pressure, Respiratory excursion | ✓ | ✓ | ✓ | |||
To be completed by examiner: | ✓ | |||||
SCID | ||||||
Suicide risk assessment | ✓ | ✓ | ✓ | ✓ | ✓ | |
Concomitant medication adherence record | ✓ | ✓ | ✓ | ✓ | ✓ | |
CIRS-G | ✓ | |||||
HAMD | ✓ | ✓ | ✓ | ✓ | ✓ | |
PASE | ✓ | ✓ | ✓ | ✓ | ✓ | |
CGI | ✓ | ✓ | ✓ | ✓ | ||
MMSE | ✓ | |||||
To be completed by participant: | ✓ | ✓ | ✓ | ✓ | ✓ | |
GDS | ||||||
GAI | ✓ | ✓ | ✓ | ✓ | ✓ | |
QOLPSV | ✓ | ✓ | ✓ | ✓ | ✓ | |
TSES | ✓ | ✓ | ✓ | ✓ | ✓ | |