title: 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).
abstract: BACKGROUND
  Stress, depression, and anxiety affect 15 to 25% of pregnant women. However, fewer than 20% of prenatal care providers assess and treat mental health problems and fewer than 20% of pregnant women seek mental healthcare. For those who seek treatment, the lack of health system integration and existing barriers frequently prevent treatment access. Without treatment, poor prenatal mental health can persist for years and impact future maternal, child, and family well-being.
  
  
  METHODS
  The purpose of this randomized controlled trial is to evaluate the effectiveness of an integrated process of online psychosocial assessment, referral, and cognitive behavior therapy (CBT) for pregnant women compared to usual prenatal care (no formal screening or specialized care). The primary outcome is self-reported prenatal depression, anxiety, and stress symptoms at 6 to 8 weeks postrandomization. Secondary outcomes are postpartum depression, anxiety, and stress symptoms; self-efficacy; mastery; self-esteem; sleep; relationship quality; coping; resilience; Apgar score; gestational age; birth weight; maternal-infant attachment; infant behavior and development; parenting stress/competence; and intervention cost-effectiveness, efficiency, feasibility, and acceptability. Pregnant women are eligible if they: 1) are <28 weeks gestation; 2) speak/read English; 3) are willing to complete email questionnaires; 4) have no, low, or moderate psychosocial risk on screening at recruitment; and 5) are eligible for CBT. A sample of 816 women will be recruited from large, urban primary care clinics and allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment, and those with mild or moderate depression, anxiety, or stress symptoms then complete six interactive cognitive behavior therapy modules. All women will complete email questionnaires at 6 to 8 weeks postrandomization and at 3, 6, and 12 months postpartum. Clinic-based providers and researchers conducting chart abstraction and analysis are blinded. Qualitative interviews with 8 to 10 healthcare providers and 15 to 30 intervention group women will provide data on feasibility and acceptability of the intervention. Results of this trial will determine the feasibility and effectiveness of an integrated approach to prenatal mental healthcare and the use of highly accessible computer-based psychosocial assessment and CBT on maternal, infant, and family-based outcomes.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01901796.
authors.affiliation: University of Alberta, 11405-87th Avenue, Edmonton T6G 1C9 AB, Canada. dawn.kingston@ualberta.ca.
authors.forename: Dawn
authors.initials: D
authors.lastname: Kingston
authors.forename: Marie-Paule
authors.initials: MP
authors.lastname: Austin
authors.forename: Kathy
authors.initials: K
authors.lastname: Hegadoren
authors.forename: Sheila
authors.initials: S
authors.lastname: McDonald
authors.forename: Gerri
authors.initials: G
authors.lastname: Lasiuk
authors.forename: Sarah
authors.initials: S
authors.lastname: McDonald
authors.forename: Maureen
authors.initials: M
authors.lastname: Heaman
authors.forename: Anne
authors.initials: A
authors.lastname: Biringer
authors.forename: Wendy
authors.initials: W
authors.lastname: Sword
authors.forename: Rebecca
authors.initials: R
authors.lastname: Giallo
authors.forename: Tejal
authors.initials: T
authors.lastname: Patel
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 / Q000628:therapy; D002170:Canada; D002657:Child Development; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D019033:Delivery of Health Care, Integrated; D019052:Depression, Postpartum / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007229:Infant Welfare / Q000191:economics; D007231:Infant, Newborn; D020407:Internet; D008427:Maternal Health Services / Q000191:economics; D008429:Maternal Welfare / Q000191:economics; D008603:Mental Health / Q000191:economics; D008605:Mental Health Services / Q000191:economics; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D011446:Prospective Studies; D012017:Referral and Consultation / Q000191:economics; D012107:Research Design; D013315:Stress, Psychological / Q000175:diagnosis / Q000523:psychology / Q000628:therapy; D013813:Therapy, Computer-Assisted / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome