Transcranial direct current stimulation as treatment for major depression in a home treatment setting (HomeDC trial): study protocol and methodology of a double-blind, placebo-controlled pilot study

Table 1 Times and events schedule

Phase	Pre-treatment period		Treatment period																														Follow-up period
Week	− 1		1					2					3					4					5					6					10	14
Study visit	S	B					1					2										3										4	5	6
Day	-14/-5	-4/1	1	2	3	4	5					12					19					26					33					40	68	96
Screening, treatment, and administrative procedures
Informed consent^a	√
Medical and psychiatric (family) history, demographic data	√
M.I.N.I	√
HDRS-17	√
Pregnancy test		√
Concomitant treatment^b		√																														√
EHI-8, ATHF		√
tDCS training		√
Blinding check																																√
Efficacy measures
MADRS	√	√					√					√										√										√	√	√
BDI-II, CGI, GAF,		√					√					√										√										√	√	√
Safety measures
CRQ			√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√	√
Adjunctive investigations^e
fMRI, sMRI, E-field Modelling		√

^aInformed consent has to be obtained prior to any study-related procedure
^bMedication, but also the kind of psychotherapeutic intervention (e.g., group therapy or individual therapy), duration, and frequency have to be recorded

ISSN: 2055-5784