Table 2 Secondary objectives, research questions, and hypotheses

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To compare the clinical effectiveness of integrated psychosocial assessment-care-referral versus usual prenatal care on postnatal mental health, psychosocial resources, infant health, and family health

Compared to usual care, what is the effect of integrated, online psychosocial care delivered in pregnancy on:

Compared to women in the control group, those in the intervention will have significantly:

-decreased presence and severity of depression, anxiety, and stress symptoms at 12 weeks postpartum;

…..prenatal and postpartum mental health?

-increased psychosocial resources (self-efficacy, mastery, self-esteem, coping); improved sleep quality; and higher relationship quality at 6 to 8 weeks postrandomization and 3, 6, and 12 months postpartum.

…infant health?

Infants of women in the intervention group will have significantly higher: 1) 5-minute Apgar scores, 2) birth weight, 3) gestational age, 4) maternal-child attachment, and 5) significantly reduced ‘dysfunctional’ infant behavior compared to the intervention group.

…family health?

The intervention group will have significantly higher parenting competence and partner relationship quality and significantly lower parenting stress compared to the control group.

To evaluate process outcomes of integrated psychosocial care

Is integrated psychosocial care more efficient, feasible, and acceptable than usual prenatal care?

Efficiency: Compared to the control group, a significantly higher percentage of women in the intervention group will have a psychosocial assessment and receive treatment. The intervention group will have significantly lower percentage of women receiving emergency mental healthcare compared to the control group.

Feasibility: ≥ 90% of providers and women report psychosocial assessment is easily done as a component of routine prenatal care, ≥ 95% of intervention group women will access cognitive behavior therapy modules (CBT) within 2 weeks of psychosocial assessment, ≥ 80% of intervention group will access the CBT modules every 1-2 weeks, ≥75% intervention group will complete all CBT exercises, and intervention group will complete 80-100% modules within 6 to 8 weeks.

Acceptability: ≥ 90% of intervention group women and providers will report tablet-based psychosocial assessment during prenatal care acceptable, > 90% women will report that they could provide ‘honest’ responses, and ≥ 90% of intervention group women and providers will find the CBT modules acceptable.

Utility: ≥ 85% of intervention group will report that the CBT homework exercises were useful, and ≥ 90% of intervention group will report each module as useful.

Usability: ≥ 90% of intervention group will report that the exercises and modules were clear, easy to understand, and easy to navigate around.

(Note. Targets are based on meta-analyses of adherence and satisfaction rates [44]).

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To describe mechanisms of integrated care

What are the mediators and moderators of the intervention effect?

Psychosocial resources (self-efficacy, mastery, self-esteem, coping), sleep, and relationship quality will mediate the impact of the intervention on maternal, child, and family outcomes; and participant characteristics will moderate the effect (for example, demographics, use of antidepressants).

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To compare the cost-effectiveness of integrated psychosocial care compared to usual care

Is the integrated psychosocial care model cost-effective when compared to usual prenatal care?

The expected incremental cost effectiveness of integrated psychosocial assessment, referral, and targeted cognitive behavioral therapy is cost effective at values of health considered acceptable in the Canadian healthcare system.