Open Access Study protocol

Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial

Dawn Kingston1*, Sheila McDonald2, Anne Biringer3, Marie-Paule Austin4, Kathy Hegadoren1, Sarah McDonald5, Rebecca Giallo6, Arto Ohinmaa1, Gerri Lasiuk1, Glenda MacQueen2, Wendy Sword5, Marie Lane-Smith1 and Sander Veldhuyzen van Zanten1

Author Affiliations

1 University of Alberta, 11405-87th Avenue, Edmonton, T6G 1C9, Canada

2 University of Calgary, Calgary, AB T2N 1 N4, Canada

3 University of Toronto, Toronto, ON, Canada

4 University of New South Wales (AU), Kensington NSW 2052, Australia

5 McMaster University, Hamilton, ON L8S 4 L8, Canada

6 Parenting Research Centre, East Melbourne, VIC 3002, Australia

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Trials 2014, 15:3  doi:10.1186/1745-6215-15-3

Published: 2 January 2014

Abstract

Background

Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed.

Methods/Design

The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening.

Trial registration

ClinicalTrials.gov Identifier: NCT01899534.

Keywords:
Psychosocial assessment; Online; Screening; Pregnancy; Depression; Anxiety; Stress; Randomized controlled trial