Table 1.
Study schedule for the participants in the pilot randomized controlled trial of transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy
Measure | Study period | Purpose | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Prior to active study phase | Active study phase | Follow-up | ||||||||
Enrolment | Baseline visit | Daily | End of week 1 | End of week 2 | End of week 3 | Every 4 weeks until delivery | 4 weeks postpartum | 12 weeks postpartum | ||
Eligibility screen | X | Feasibility | ||||||||
Informed consent | X | Feasibility | ||||||||
Group allocation | X | Feasibility | ||||||||
Demographic questionnaire | X | Covariates | ||||||||
Mini International Neuropsychiatric Interview | X | Covariates | ||||||||
Health service use questionnaire | X | X | X | X | X | X | X | Covariates | ||
Montgomery Asberg Depression Rating Scale | X | X | X | X | X | X | X | Adherence, efficacy | ||
Edinburgh Postnatal Depression Scale | X | X | X | X | X | X | X | Adherence, efficacy | ||
Pregnancy Experience Scale | X | X | X | X | X | X | X | Adherence, efficacy | ||
State-Trait Anxiety Inventory | X | X | X | X | X | X | X | Adherence, efficacy | ||
Pregnancy complications | X | X | X | X | X | X | Acceptability, adherence | |||
Fetal monitoring | X | Acceptability, adherence | ||||||||
Treatment allocation questionnaire | X | X | X | Feasibility | ||||||
Toronto Side Effects Questionnaire | X | X | X | Acceptability, adherence | ||||||
Treatment perceptions interview | X | Acceptability, adherence | ||||||||
Neonatal outcomes | X | Acceptability, adherence | ||||||||
Infant characteristics questionnaire | X | Acceptability, adherence | ||||||||
Ages and Stages Questionnaire-3 | X | Acceptability, adherence |