Internet-based behavioural activation to improve depressive symptoms and prevent child abuse in postnatal women (SmartMama): a protocol for a pragmatic randomized controlled trial

Table 2 Schedule of enrolment, interventions, and assessments

		Enrolment	Allocation	Post-allocation
TIMEPOINT		T0	0	12 weeks follow-up (T1)	24 weeks follow-up (T2)
ENROLMENT:
Eligibility screen		X
Informed consent		X
Allocation			X
INTERVENTIONS:
Intervention group
Control group
ASSESSMENTS:	Aim
Co-primary outcomes
EPDS	Maternal depressive symptoms	X		X	X
CTS-1	Psychological aggression toward children	X		X	X
Secondary outcomes
Maternal
PHQ-9	Depresssive symptoms	X		X	X
PSI-SF	Parent stress	X		X	X
MIBS-J	Mother-to-infant bonding	X		X	X
EQ-5D-5L	Quality of life	X		X	X
Use of inpatient and outpatient medical care in the past 3 months	Medical cost	X		X	X
Paediatric
Height, body weight	Physical development	X		X	X
Type of nutrition (breast milk, formula, both, baby food)	Nutritional status	X		X	X
Attendance of well-baby visits at 1, 3, 6–7, 9–10 months)	Health check-up status	X		X	X
Immunization record (Hib, pneumococcus, DPT-IPV, rotavirus, BCG)	Immunization status	X		X	X
Use of inpatient and outpatient medical care for injuries, foreign body ingestion, burn, and drowning in the 3 months	Medical cost for injuries	X		X	X
Implementation
Implementation outcome scale for Digital Mental Health (IDMH) for users	Acceptability, appropriateness, feasibility, overall satisfaction, and harms			X

EPDS Edinburgh Postnatal Depression Scale, CTS-1 Conflict Tactics Scale, PHQ-9 Patient Heatlh Questionnaire-9, PSI-SF Parent stress index-short form Japanese version, MIBS-J Mother-to-Infant Bonding Scale Japanese version, EQ-5D-5L EuroQol-5 dimension-5 level

ISSN: 1471-2393