Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial

Authors: Simone Vigod, Neesha Hussain-Shamsy, Sophie Grigoriadis, Louise M. Howard, Kelly Metcalfe, Tim F. Oberlander, Carrie Schram, Donna E. Stewart, Valerie H. Taylor, Cindy-Lee Dennis

Published in: Trials | Issue 1/2016

Login to get access

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/Design

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.

Discussion

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.

Trial registration

This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).
Appendix
Available only for authorised users
Literature
1.
Bennett HA et al. Prevalence of depression during pregnancy: systematic review. Obstet Gynecol. 2004;103(4):698–709.CrossRefPubMed
2.
Gavin NI et al. Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol. 2005;106(5 Pt 1):1071–83.CrossRefPubMed
3.
4.
Marcus SM. Depression during pregnancy: rates, risks and consequences – Motherisk Update 2008. Can J Clin Pharmacol. 2009;16(1):e15–22.PubMed
5.
Beck CT. The effects of postpartum depression on child development: a meta-analysis. Arch Psychiatr Nurs. 1998;12(1):12–20.CrossRefPubMed
6.
Hammen C, Brennan PA. Severity, chronicity, and timing of maternal depression and risk for adolescent offspring diagnoses in a community sample. Arch Gen Psychiatry. 2003;60(3):253–8.CrossRefPubMed
7.
Martins C, Gaffan EA. Effects of early maternal depression on patterns of infant-mother attachment: a meta-analytic investigation. J Child Psychol Psychiatry. 2000;41(6):737–46.CrossRefPubMed
8.
Murray L. The impact of postnatal depression on infant development. J Child Psychol Psychiatry. 1992;33(3):543–61.CrossRefPubMed
9.
Nulman I et al. Child development following exposure to tricyclic antidepressants or fluoxetine throughout fetal life: a prospective, controlled study. Am J Psychiatry. 2002;159(11):1889–95.CrossRefPubMed
10.
O’Hara MW, Swain AM. Rates and risk of postpartum depression – A meta-analysis. Int Rev Psychiatry. 1996;8(1):37–54.CrossRef
11.
Sinclair D, Murray L. Effects of postnatal depression on children’s adjustment to school. Teacher’s reports. Br J Psychiatry. 1998;172:58–63.CrossRefPubMed
12.
Weinberg MK, Tronick EZ. The impact of maternal psychiatric illness on infant development. J Clin Psychiatry. 1998;59 Suppl 2:53–61.PubMed
13.
Weikum WM et al. Prenatal exposure to antidepressants and depressed maternal mood alter trajectory of infant speech perception. Proc Natl Acad Sci U S A. 2012;109 Suppl 2:17221–7.CrossRefPubMedPubMedCentral
14.
CANMAT. Clinical guidelines for the treatment of depressive disorders. Can J Psychiatry. 2001;46 Suppl 1:5S–90S.
15.
Dennis CL. Treatment of postpartum depression, part 2: a critical review of nonbiological interventions. J Clin Psychiatry. 2004;65(9):1252–65.CrossRefPubMed
16.
Dennis CL. Preventing postpartum depression part I: a review of biological interventions. Can J Psychiatry. 2004;49(7):467–75.PubMed
17.
Dennis CL. Preventing postpartum depression part II: a critical review of nonbiological interventions. Can J Psychiatry. 2004;49(8):526–38.CrossRefPubMed
18.
Dennis CL, Stewart DE. Treatment of postpartum depression, part 1: a critical review of biological interventions. J Clin Psychiatry. 2004;65(9):1242–51.CrossRefPubMed
19.
Gjerdingen D. The effectiveness of various postpartum depression treatments and the impact of antidepressant drugs on nursing infants. J Am Board Fam Pract. 2003;16(5):372–82.CrossRefPubMed
20.
Sharma V. Pharmacotherapy of postpartum depression. Expert Opin Pharmacother. 2002;3(10):1421–31.CrossRefPubMed
21.
Rush AJ et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905–17.CrossRefPubMed
22.
Cohen LS et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295(5):499–507.CrossRefPubMed
23.
Pedersen LH et al. Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study. BMJ. 2009;339:b3569.CrossRefPubMedPubMedCentral
24.
Chambers CD et al. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med. 2006;354(6):579–87.CrossRefPubMed
25.
Kieler H et al. Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries. BMJ. 2012;344:d8012.CrossRefPubMed
26.
Wen SW et al. Selective serotonin reuptake inhibitors and adverse pregnancy outcomes. Am J Obstet Gynecol. 2006;194(4):961–6.CrossRefPubMed
27.
28.
Casper RC et al. Follow-up of children of depressed mothers exposed or not exposed to antidepressant drugs during pregnancy. J Pediatr. 2003;142(4):402–8.CrossRefPubMed
29.
Chambers CD et al. Birth outcomes in pregnant women taking fluoxetine. N Engl J Med. 1996;335(14):1010–5.CrossRefPubMed
30.
Cohen LS et al. Birth outcomes following prenatal exposure to fluoxetine. Biol Psychiatry. 2000;48(10):996–1000.CrossRefPubMed
31.
Costei AM et al. Perinatal outcome following third trimester exposure to paroxetine. Arch Pediatr Adolesc Med. 2002;156(11):1129–32.CrossRefPubMed
32.
Ericson A, Kallen B, Wiholm B. Delivery outcome after the use of antidepressants in early pregnancy. Eur J Clin Pharmacol. 1999;55(7):503–8.CrossRefPubMed
33.
Kulin NA et al. Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study. JAMA. 1998;279(8):609–10.CrossRefPubMed
34.
Laine K et al. Effects of exposure to selective serotonin reuptake inhibitors during pregnancy on serotonergic symptoms in newborns and cord blood monoamine and prolactin concentrations. Arch Gen Psychiatry. 2003;60(7):720–6.CrossRefPubMed
35.
Levinson-Castiel R et al. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med. 2006;160(2):173–6.CrossRefPubMed
36.
Nordeng H et al. Neonatal withdrawal syndrome after in utero exposure to selective serotonin reuptake inhibitors. Acta Paediatr. 2001;90(3):288–91.CrossRefPubMed
37.
Oberlander TF et al. Prolonged prenatal psychotropic medication exposure alters neonatal acute pain response. Pediatr Res. 2002;51(4):443–53.CrossRefPubMed
38.
Pastuszak A et al. Pregnancy outcome following first-trimester exposure to fluoxetine (Prozac). JAMA. 1993;269(17):2246–8.CrossRefPubMed
39.
Simon GE, Cunningham ML, Davis RL. Outcomes of prenatal antidepressant exposure. Am J Psychiatry. 2002;159(12):2055–61.CrossRefPubMed
40.
41.
Nulman I et al. Neurodevelopment of children following prenatal exposure to venlafaxine, selective serotonin reuptake inhibitors, or untreated maternal depression. Am J Psychiatry. 2012;169(11):1165–74.CrossRefPubMed
42.
Mulder EJ et al. Selective serotonin reuptake inhibitors affect neurobehavioral development in the human fetus. Neuropsychopharmacology. 2011;36(10):1961–71.CrossRefPubMedPubMedCentral
43.
44.
Walton GD, Ross LE, Stewart DE, Grigoriadis S, Dennis CL, Vigod S. Decisional conflict among women considering antidepressant medication use in pregnancy. Arch Womens Ment Health. 2014;17(6):493–501. doi: 10.​1007/​s00737-014-0448-1.
45.
46.
Coulter A, Kryworuchko J, Mullen PD, Ng CJ, Stilwell D, van der Weijden T. Chapter A: using a systematic development process, in update of the International Patient Decision Aids Standards (IPDAS) Collaborations’ Background Document, Llewellyn-Thomas HA, Volk RJ, editors. 2012. pp. 1–16. http://​ipdas.​ohri.​ca/​resources.​html. Accessed 23 Feb 2016.
47.
Stacey D et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011;10:CD001431.
48.
Kasper JF, Mulley Jr AG, Wennberg JE. Developing shared decision-making programs to improve the quality of health care. QRB Qual Rev Bull. 1992;18(6):183–90.CrossRefPubMed
49.
Levine MN et al. A bedside decision instrument to elicit a patient’s preference concerning adjuvant chemotherapy for breast cancer. Ann Intern Med. 1992;117(1):53–8.CrossRefPubMed
50.
O’Connor AM, Jacobsen MJ, Stacey D. An evidence-based approach to managing women’s decisional conflict. J Obstet Gynecol Neonatal Nurs. 2002;31(5):570–81.CrossRefPubMed
51.
O’Connor AM et al. The Ottawa patient decision aids. Eff Clin Pract. 1999;2(4):163–70.PubMed
52.
Gibson J et al. A systematic review of studies validating the Edinburgh Postnatal Depression Scale in antepartum and postpartum women. Acta Psychiatr Scand. 2009;119(5):350–64.CrossRefPubMed
53.
Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987;150:782–6.CrossRefPubMed
54.
Dennis CL, Coghlan M, Vigod S. Can we identify mothers at-risk for postpartum anxiety in the immediate postpartum period using the State-Trait Anxiety Inventory? J Affect Disord. 2013;150(3):1217–20. doi: 10.​1016/​j.​jad.​2013.​05.​049.
55.
Metcalfe KA et al. Development and testing of a decision aid for breast cancer prevention for women with a BRCA1 or BRCA2 mutation. Clin Genet. 2007;72(3):208–17.CrossRefPubMed
56.
Watson M et al. Measuring contamination in an injury prevention randomized controlled trial. Int J Inj Contr Saf Promot. 2005;12(3):197–9.CrossRefPubMed
57.
Cook JA, Ramsay CR, Fayers P. Statistical evaluation of learning curve effects in surgical trials. Clin Trials. 2004;1(5):421–7.CrossRefPubMed
58.
Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008;31(2):180–91.CrossRefPubMed
Metadata
Title
A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial
Authors
Simone Vigod
Neesha Hussain-Shamsy
Sophie Grigoriadis
Louise M. Howard
Kelly Metcalfe
Tim F. Oberlander
Carrie Schram
Donna E. Stewart
Valerie H. Taylor
Cindy-Lee Dennis
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1233-4

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial

Study protocol

Improving access to primary care for Aboriginal babies in Western Australia: study protocol for a randomized controlled trial

Study protocol

Development of a core outcome set for use in determining the overall success of gastroschisis treatment

Research

Guidelines for reporting embedded recruitment trials

Study protocol

Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial

Research

Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong