title: A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy.
  
  
  METHODS
  This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ≥25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms.
  
  
  CONCLUSIONS
  Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated.
  
  
  BACKGROUND
  This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON, M5S 1B2, Canada. simone.vigod@wchospital.ca.|University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. simone.vigod@wchospital.ca.
authors.forename: Simone
authors.initials: S
authors.lastname: Vigod
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON, M5S 1B2, Canada. neesha.hussainshamsy@wchospital.ca.
authors.forename: Neesha
authors.initials: N
authors.lastname: Hussain-Shamsy
authors.affiliation: University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. sophie.grigoriadis@sunnybrook.ca.|Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, ON, M4N 3M5, Canada. sophie.grigoriadis@sunnybrook.ca.
authors.forename: Sophie
authors.initials: S
authors.lastname: Grigoriadis
authors.affiliation: King's College London, Institute of Psychiatry, Box P031, De Crespigny Park, London, SE5 8AF, United Kingdom. louise.howard@kcl.ac.uk.
authors.forename: Louise M
authors.initials: LM
authors.lastname: Howard
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON, M5S 1B2, Canada. kelly.metcalfe@utoronto.ca.|University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. kelly.metcalfe@utoronto.ca.
authors.forename: Kelly
authors.initials: K
authors.lastname: Metcalfe
authors.affiliation: Department of Pediatrics, University of British Columbia, Child and Family Research Institute, 4480 Oak St., Vancouver, BC, V6H 3V4, Canada. toberlander@cw.bc.ca.
authors.forename: Tim F
authors.initials: TF
authors.lastname: Oberlander
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON, M5S 1B2, Canada. carrie.schram@wchospital.ca.|University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. carrie.schram@wchospital.ca.
authors.forename: Carrie
authors.initials: C
authors.lastname: Schram
authors.affiliation: University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. donna.stewart@uhn.ca.|University Health Network, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada. donna.stewart@uhn.ca.
authors.forename: Donna E
authors.initials: DE
authors.lastname: Stewart
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON, M5S 1B2, Canada. valerie.taylor@wchospital.ca.|University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. valerie.taylor@wchospital.ca.
authors.forename: Valerie H
authors.initials: VH
authors.lastname: Taylor
authors.affiliation: Women's College Hospital and Research Institute, 76 Grenville Street, Toronto, ON, M5S 1B2, Canada. cindylee.dennis@utoronto.ca.|University of Toronto, 1 King's College Circle, Toronto, ON, M5S 1A8, Canada. cindylee.dennis@utoronto.ca.
authors.forename: Cindy-Lee
authors.initials: CL
authors.lastname: Dennis
mesh_terms: D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D003220:Conflict, Psychological; D003661:Decision Support Techniques; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009864:Ontario; D010358:Patient Participation; D061214:Patient Safety; D010865:Pilot Projects; D011247:Pregnancy; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors; D000068760:Serotonin and Noradrenaline Reuptake Inhibitors