Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial

Table 1 Schedule for treatment and outcome measurements

Period	S	T									Follow-up
Visit		1	2	3	4–12	13	14	15–18	19	20	21	22
Week		1	1	1	2–4	5	5	6–7	8	8	9	13
Informed consent	●
Inclusion/exclusion criteria	●
Laboratory test^a	●										●
Vital signs	●	●	●	●	●	●	●	●	●	●	●	●
Demographic characteristics	●
Medical history/BMI	●
SRRS	●
SDTS	●					●					●
Random allocation		●^b
Change of history		●	●	●	●	●	●	●	●	●	●	●
Treatment		●	●	●	●	●	●	●	●	●
HAM-D	●	●^b				●^b					●	●
BDI		●^b				●^b					●	●
EQ-5D		●^b				●^b					●	●
ISI		●^b				●^b					●	●
STAI		●^b				●^b					●	●
MYMOP2		●^b				●^b					●	●
EEG		●^b				●^b					●	●
Pattern identification		●^b
Safety assessment		●	●	●	●	●	●	●	●	●	●	●
Blinding test		●								●

S screening period, T treatment period, BMI Body Mass Index, SRRS Social Readjustment of Rating Scale, SDTS Screening for Depression and Thoughts of Suicide, HAM-D Hamilton Rating Scale for Depression, BDI Beck’s Depression Inventory, EQ-5D EuroQol-5 Dimension Index, ISI Insomnia Severity Index, STAI State-Trait Anxiety Inventory, MYMOP2 Measure Yourself Medical Outcome Profile version 2, EEG electroencephalography
^aComplete blood count and differential count, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, total bilirubin, albumin, erythrocyte sedimentation rate, thyroid-stimulating hormone, free thyroxine, human chorionic gonadotropin urine test (only for women in their childbearing years)
^bBefore treatment

ISSN: 1745-6215