title: 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.
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
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01899534.
authors.affiliation: University of Alberta, 11405-87th Avenue, Edmonton, T6G 1C9, Canada. dawn.kingston@ualberta.ca.
authors.forename: Dawn
authors.initials: D
authors.lastname: Kingston
authors.forename: Sheila
authors.initials: S
authors.lastname: McDonald
authors.forename: Anne
authors.initials: A
authors.lastname: Biringer
authors.forename: Marie-Paule
authors.initials: MP
authors.lastname: Austin
authors.forename: Kathy
authors.initials: K
authors.lastname: Hegadoren
authors.forename: Sarah
authors.initials: S
authors.lastname: McDonald
authors.forename: Rebecca
authors.initials: R
authors.lastname: Giallo
authors.forename: Arto
authors.initials: A
authors.lastname: Ohinmaa
authors.forename: Gerri
authors.initials: G
authors.lastname: Lasiuk
authors.forename: Glenda
authors.initials: G
authors.lastname: MacQueen
authors.forename: Wendy
authors.initials: W
authors.lastname: Sword
authors.forename: Marie
authors.initials: M
authors.lastname: Lane-Smith
authors.forename: Sander Veldhuyzen
authors.initials: SV
authors.lastname: van Zanten
mesh_terms: D001007:Anxiety / Q000175:diagnosis* / Q000523:psychology; D002170:Canada; D002985:Clinical Protocols; D034201:Computers, Handheld; D003863:Depression / Q000175:diagnosis* / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D020407:Internet; D008603:Mental Health; D008605:Mental Health Services; D011237:Predictive Value of Tests; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis* / Q000523:psychology; D011295:Prenatal Care; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D012107:Research Design; D012307:Risk Factors; D011795:Surveys and Questionnaires; D019037:Urban Health Services