Measure | Study period | Purpose | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Prior to active study phase | Active study phase | Follow-up | Â | |||||||
Enrolment | Baseline visit | Daily | End of week 1 | End of week 2 | End of week 3 | Every 4Â weeks until delivery | 4Â weeks postpartum | 12Â weeks postpartum | ||
Eligibility screen | X | Â | Â | Â | Â | Â | Â | Â | Â | Feasibility |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Feasibility |
Group allocation | Â | X | Â | Â | Â | Â | Â | Â | Â | Feasibility |
Demographic questionnaire | Â | X | Â | Â | Â | Â | Â | Â | Â | Covariates |
Mini International Neuropsychiatric Interview | Â | X | Â | Â | Â | Â | Â | Â | Â | Covariates |
Health service use questionnaire | Â | X | Â | X | X | X | X | X | X | Covariates |
Montgomery Asberg Depression Rating Scale | Â | X | Â | X | X | X | X | X | X | Adherence, efficacy |
Edinburgh Postnatal Depression Scale | Â | X | Â | X | X | X | X | X | X | Adherence, efficacy |
Pregnancy Experience Scale | Â | X | Â | X | X | X | X | X | X | Adherence, efficacy |
State-Trait Anxiety Inventory | Â | X | Â | X | X | X | X | X | X | Adherence, efficacy |
Pregnancy complications | Â | X | Â | X | X | X | X | X | Â | Acceptability, adherence |
Fetal monitoring | Â | Â | X | Â | Â | Â | Â | Â | Â | Acceptability, adherence |
Treatment allocation questionnaire | Â | Â | Â | X | X | X | Â | Â | Â | Feasibility |
Toronto Side Effects Questionnaire | Â | Â | Â | X | X | X | Â | Â | Â | Acceptability, adherence |
Treatment perceptions interview | Â | Â | Â | Â | Â | X | Â | Â | Â | Acceptability, adherence |
Neonatal outcomes | Â | Â | Â | Â | Â | Â | Â | X | Â | Acceptability, adherence |
Infant characteristics questionnaire | Â | Â | Â | Â | Â | Â | Â | Â | X | Acceptability, adherence |
Ages and Stages Questionnaire-3 | Â | Â | Â | Â | Â | Â | Â | Â | X | Acceptability, adherence |