Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)

Table 6 Schedule of enrollment, interventions, and assessments

	Enrollment	Allocation	CBT Suitability	Post-randomization
TIME POINT	-t ₁	0	0	T ₁ _(Baseline)	T ₂ _{(6 to 8 weeks postrandomization)}	T ₃ _{(3 months postpartum)}	T ₄ _{(6 months postpartum)}	T ₅ _{(12 months postpartum)}
ENROLLMENT:
Eligibility screen (based on DASS21 and EPDS)	X
Informed consent	X
Allocation		X
Determination of suitability for CBT (based on ANRQ-R)			X
INTERVENTIONS:
Psychosocial assessment (ANRQ-R)				X
Referral				X
Online cognitive behavior therapy				X	X
ASSESSMENTS:
Baseline variables^a				X
Primary outcome: Depression, anxiety, stress symptoms	X			X	X
Secondary outcomes -maternal^b				X	X
Secondary outcomes -maternal and infant^c						X	X	X
Utility, usability, acceptability of intervention					X
Phase 2: Qualitative interviews					X	X	X

ANRQ-R, Antenatal Risk Questionnaire; CBT, cognitive behavior therapy; DASS21, Depression, Anxiety, Stress Scale; EPDS, Edinburgh Postnatal Depression Scale.
^aBaseline variables: demographics; history-obstetric, medical, mental health diagnosis and treatment; social support; mastery; self-efficacy; resilience; sleep; partner relationship; coping.
^bSecondary outcomes - maternal: mental health treatment; social support; mastery; self-efficacy; resilience; sleep; partner relationship; coping; mental health service utilization.
^cSecondary outcomes - maternal and infant: mental health treatment; social support; mastery; self-efficacy; resilience; sleep; partner relationship; coping; parenting competence; parenting stress; maternal-infant attachment; infant behavior; infant development; gestational age; birth weight; 5-minute Apgar Score; mental health service utilization; quality of life.

ISSN: 1745-6215