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Table 1 Primary objective, research question, and hypotheses

From: 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)

Gap

objective

Research question

Testable hypotheses

1

To compare the clinical effectiveness of integrated psychosocial assessment-care-referral versus usual prenatal care on prenatal depression, anxiety, and stress symptoms

What is the effect of integrated, online psychosocial care delivered in pregnancy to women with low or moderate psychosocial risk on the presence and severity of prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks post-randomization compared to usual prenatal care?

Presence of symptoms: Compared to women in the control group, fewer women in the intervention group will have depression, anxiety, and stress symptoms (for example, be above the established cut-off for the DASS21 and EPDS).

Severity of symptoms: Women in the intervention group will have lower severity of depression, anxiety, and stress (that is, they will have lower mean scores on the depression, anxiety, and stress subscales) compared to those in the control group.