Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: Study protocol of a pragmatic multicentre non-inferiority randomized controlled trial

BMC Psychiatry

Volumn 16, Issue 1, 2016, Pages

  Molenaar, Nina M ^b   Brouwer, Marlies E ^a   Bockting, Claudi L H ^a   Bonsel, Gouke J ^b   van der Veere, Christine N ^c   Torij, Hanneke W ^b   Hoogendijk, Witte J G ^b   Duvekot, Johannes J ^b   Burger, Huibert ^c   Lambregtse van den Berg, Mijke P ^b,d  

^a UTRECHT UNIVERSITY   (Netherlands)

^b ERASMUS MEDICAL CENTER   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^d SOPHIA CHILDREN S HOSPITAL   (Netherlands)

Author keywords

Antidepressants; Cognitive therapy; Cost effectiveness; Depression; Perinatal outcome; Pregnancy; Prevention; Recurrence; Relapse; Selective serotonin reuptake inhibitors; SSRI

Indexed keywords

SEROTONIN UPTAKE INHIBITOR; ANTIDEPRESSANT AGENT;

ARTICLE; BEHAVIOR ASSESSMENT; COGNITIVE THERAPY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FEMALE; GESTATIONAL AGE; HEALTH CARE COST; HUMAN; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PREVENTIVE COGNITIVE THERAPY; PROPHYLAXIS; PSYCHOMOTOR ACTIVITY; PUERPERAL DEPRESSION; QUALITY ADJUSTED LIFE YEAR; RANDOMIZED CONTROLLED TRIAL; RECURRENT DISEASE; RELAPSE; STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS; TREATMENT OUTCOME; ADULT; CLINICAL PROTOCOL; CLINICAL TRIAL; DEPRESSIVE DISORDER; NETHERLANDS; PREGNANCY; PRENATAL EXPOSURE; PREVENTION AND CONTROL; PROCEDURES;

ADULT; ANTIDEPRESSIVE AGENTS; CLINICAL PROTOCOLS; COGNITIVE THERAPY; DEPRESSIVE DISORDER; FEMALE; HUMANS; NETHERLANDS; PREGNANCY; PRENATAL EXPOSURE DELAYED EFFECTS; SEROTONIN UPTAKE INHIBITORS;

EID: 84961200966     PISSN: None     EISSN: 1471244X     Source Type: Journal    
DOI: 10.1186/s12888-016-0752-6     Document Type: Article

References (68)

1. Andrade SE, Raebel MA, Brown J, Lane K, Livingston J, Boudreau D, et al. Use of antidepressant medications during pregnancy: a multisite study. Am J Obstet Gynecol. 2008;198(2):194. doi: 10.1016/j.ajog.2007.07.036. e1-5.
2. Charlton RA, Jordan S, Pierini A, Garne E, Neville AJ, Hansen AV, et al. Selective serotonin reuptake inhibitor prescribing before, during and after pregnancy: a population-based study in six European regions. BJOG. 2015;122(7):1010-20. doi: 10.1111/1471-0528.13143.
3. Bakker MK, Kolling P, van den Berg PB, de Walle HE, de Jong van den Berg LT. Increase in use of selective serotonin reuptake inhibitors in pregnancy during the last decade, a population-based cohort study from the Netherlands. Br J Clin Pharmacol. 2008;65(4):600-6. doi: 10.1111/j.1365-2125.2007.03048.x.
4. Ververs T, Kaasenbrood H, Visser G, Schobben F, de Jong-van den Berg L, Egberts T. Prevalence and patterns of antidepressant drug use during pregnancy. Eur J Clin Pharmacol. 2006;62(10):863-70. doi: 10.1007/s00228-006-0177-0.
5. Quispel C, Schneider TAJ, Bonsel GJ, Lambregtse-van den Berg MP. An innovative screen-and-advice model for psychopathology and psychosocial problems among urban pregnant women: an exploratory study. J Psychosom Obstet Gynecol. 2012;33(1):7-14.
6. Gynaecologie NVvOe. Richtlijn: SSRI-gebruik in de zwangerschap en tijdens de lactatie. 2012.
7. Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, et al. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006;295(5):499-507. doi: 10.1001/jama.295.5.499.
8. Yonkers KA, Gotman N, Smith MV, Forray A, Belanger K, Brunetto WL, et al. Does antidepressant use attenuate the risk of a major depressive episode in pregnancy? Epidemiology. 2011;22(6):848-54. doi: 10.1097/EDE.0b013e3182306847.
9. De Vera MA, Berard A. Antidepressant use during pregnancy and the risk of pregnancy-induced hypertension. Br J Clin Pharmacol. 2012;74(2):362-9. doi: 10.1111/j.1365-2125.2012.04196.x.
10. Kurki T, Hiilesmaa V, Raitasalo R, Mattila H, Ylikorkala O. Depression and anxiety in early pregnancy and risk for preeclampsia. Obstet Gynecol. 2000;95(4):487-90.
11. Grigoriadis S, VonderPorten EH, Mamisashvili L, Roerecke M, Rehm J, Dennis CL, et al. Antidepressant exposure during pregnancy and congenital malformations: Is there an association? A systematic review and meta-analysis of the best evidence. J Clin Psychiatry. 2013;74(4):e293-308. doi: 10.4088/JCP.12r07966.
12. Furu K, Kieler H, Haglund B, Engeland A, Selmer R, Stephansson O, et al. Selective serotonin reuptake inhibitors and venlafaxine in early pregnancy and risk of birth defects: population based cohort study and sibling design. BMJ. 2015;350:h1798. doi: 10.1136/bmj.h1798.
13. Kieler H, Artama M, Engeland A, Ericsson O, Furu K, Gissler M 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 (Online). 2012;344(7842). doi:10.1136/bmj.d8012
14. Huybrechts KF, Bateman BT, Palmsten K, Desai RJ, Patorno E, Gopalakrishnan C, et al. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA. 2015;313(21):2142-51. doi: 10.1001/jama.2015.5605.
15. Grigoriadis S, VonderPorten EH, Mamisashvili L, Eady A, Tomlinson G, Dennis CL, et al. The effect of prenatal antidepressant exposure on neonatal adaptation: a systematic review and meta-analysis. J Clin Psychiatry. 2013;74(4):e309-20. doi: 10.4088/JCP.12r07967.
16. Ross LE, Grigoriadis S, Mamisashvili L, Vonderporten EH, Roerecke M, Rehm J, et al. Selected pregnancy and delivery outcomes after exposure to antidepressant medication: A systematic review and meta-analysis. JAMA Psychiatry. 2013;70(4):436-43. doi: 10.1001/jamapsychiatry.2013.684.
17. Gentile S, Galbally M. Prenatal exposure to antidepressant medications and neurodevelopmental outcomes: a systematic review. J Affective Disord. 2011;128(1-2):1-9. doi: 10.1016/j.jad.2010.02.125.
18. Croen LA, Grether JK, Yoshida CK, Odouli R, Hendrick V. Antidepressant use during pregnancy and childhood autism spectrum disorders. Arch Gen Psychiatry. 2011;68(11):1104-12. doi: 10.1001/archgenpsychiatry.2011.73.
19. Hviid A, Melbye M, Pasternak B. Use of selective serotonin reuptake inhibitors during pregnancy and risk of autism. New Engl J Med. 2013;369(25):2406-15. doi: 10.1056/NEJMoa1301449.
20. Talge NM, Neal C, Glover V, Early Stress TR, Prevention Science Network F, Neonatal Experience on C, et al. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J Child Psychol Psychiatry. 2007;48(3-4):245-61. doi: 10.1111/j.1469-7610.2006.01714.x.
21. Field T. Prenatal depression effects on early development: a review. Infant Behav Dev. 2011;34(1):1-14. doi: 10.1016/j.infbeh.2010.09.008.
22. Oberlander TF, Weinberg J, Papsdorf M, Grunau R, Misri S, Devlin AM. Prenatal exposure to maternal depression, neonatal methylation of human glucocorticoid receptor gene (NR3C1) and infant cortisol stress responses. Epigenetics. 2008;3(2):97-106.
23. Grote NK, Bridge JA, Gavin AR, Melville JL, Iyengar S, Katon WJ. A meta-analysis of depression during pregnancy and the risk of preterm birth, low birth weight, and intrauterine growth restriction. Arch Gen Psychiatry. 2010;67(10):1012-24. doi: 10.1001/archgenpsychiatry.2010.111.
24. Grigoriadis S, VonderPorten EH, Mamisashvili L, Tomlinson G, Dennis CL, Koren G, et al. The impact of maternal depression during pregnancy on perinatal outcomes: A systematic review and meta-analysis. J Clin Psychiatry. 2013;74(4):e321-41. doi: 10.4088/JCP.12r07968.
25. Battle CL, Salisbury AL, Schofield CA, Ortiz-Hernandez S. Perinatal antidepressant use: understanding women's preferences and concerns. J Psychiatr Pract. 2013;19(6):443-53. doi: 10.1097/01.pra.0000438183.74359.46.
26. Sockol LE. A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. J Affect Disord. 2015;177:7-21. doi: 10.1016/j.jad.2015.01.052.
27. Bockting CL, Schene AH, Spinhoven P, Koeter MW, Wouters LF, Huyser J, et al. Preventing relapse/recurrence in recurrent depression with cognitive therapy: a randomized controlled trial. J Consult Clin Psychol. 2005;73(4):647-57. doi: 10.1037/0022-006X.73.4.647.
28. Bockting CL, Smid NH, Koeter MW, Spinhoven P, Beck AT, Schene AH. Enduring effects of preventive cognitive therapy in adults remitted from recurrent depression: a 10year follow-up of a randomized controlled trial. J Affect Disord. 2015;185:188-94. doi: 10.1016/j.jad.2015.06.048.
29. Kuyken W, Hayes R, Barrett B, Byng R, Dalgleish T, Kessler D, et al. Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial. Lancet. 2015;386(9988):63-73. doi: 10.1016/S0140-6736(14)62222-4.
30. Ververs T, van Dijk L, Yousofi S, Schobben F, Visser GH. Depression during pregnancy: views on antidepressant use and information sources of general practitioners and pharmacists. BMC Health Serv Res. 2009;9:119. doi: 10.1186/1472-6963-9-119.
31. Hampton T. Antidepressants and pregnancy: weighing risks and benefits no easy task. JAMA. 2006;295(14):1631-3. doi: 10.1001/jama.295.14.1631.
32. Excellence NIfHaC. Antenatal and postnatal mental health: clinical management and service guidance. 2014.
33. Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, et al. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009;114(3):703-13. doi: 10.1097/AOG.0b013e3181ba0632.
34. Levinson-Castiel R, Merlob P, Linder N, Sirota L, Klinger G. Neonatal abstinence syndrome after in utero exposure to selective serotonin reuptake inhibitors in term infants. Arch Pediatr Adolesc Med. 2006;160(2):173-6. doi: 10.1001/archpedi.160.2.173.
35. Bockting CL, Hollon SD, Jarrett RB, Kuyken W, Dobson K. A lifetime approach to major depressive disorder: the contributions of psychological interventions in preventing relapse and recurrence. Clin Psychol Rev. 2015;41:16-26. doi: 10.1016/j.cpr.2015.02.003.
36. First MB, Spitzer RL, Gibbon M, Williams JB. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition. Biometrics Research. New York: New York State Psychiatric Institute; 2002.
37. Hamilton M. Rating depressive patients. J Clin Psychiatry. 1980;41(12 Pt 2):21-4.
38. Bockting CL, Elgersma HJ, van Rijsbergen GD, de Jonge P, Ormel J, Buskens E, et al. Disrupting the rhythm of depression: design and protocol of a randomized controlled trial on preventing relapse using brief cognitive therapy with or without antidepressants. BMC Psychiatry. 2011;11:8. doi: 10.1186/1471-244X-11-8.
39. Guidi J, Fava GA, Fava M, Papakostas GI. Efficacy of the sequential integration of psychotherapy and pharmacotherapy in major depressive disorder: a preliminary meta-analysis. Psychol Med. 2011;41(2):321-31. doi: 10.1017/S0033291710000826.
40. Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.
41. Bockting CL, Spinhoven P, Wouters LF, Koeter MW, Schene AH, Group DS. Long-term effects of preventive cognitive therapy in recurrent depression: a 5.5-year follow-up study. J Clin Psychiatry. 2009;70(12):1621-8. doi: 10.4088/JCP.08m04784blu.
42. Guidi J, Tomba E, Fava GA. The sequential integration of pharmacotherapy and psychotherapy in the treatment of major depressive disorder: a meta-analysis of the sequential model and a critical review of the literature. Am J Psychiatry. 2015:appiajp201515040476. doi:10.1176/appi.ajp.2015.15040476.
43. Bockting CL, Kok GD, van der Kamp L, Smit F, van Valen E, Schoevers R, et al. Disrupting the rhythm of depression using mobile cognitive therapy for recurrent depression: randomized controlled trial design and protocol. BMC Psychiatry. 2011;11:12. doi: 10.1186/1471-244X-11-12.
44. Bee PE, Bower P, Lovell K, Gilbody S, Richards D, Gask L, et al. Psychotherapy mediated by remote communication technologies: a meta-analytic review. BMC Psychiatry. 2008;8:60. doi: 10.1186/1471-244X-8-60.
45. Dennis CL, Kingston D. A systematic review of telephone support for women during pregnancy and the early postpartum period. J Obstet Gynecol Neonatal Nurs. 2008;37(3):301-14. doi: 10.1111/j.1552-6909.2008.00235.x.
46. Lavender T, Richens Y, Milan SJ, Smyth RM, Dowswell T. Telephone support for women during pregnancy and the first six weeks postpartum. Cochrane Database Syst Rev. 2013;7:CD009338.
47. Kingston D, Austin MP, Hegadoren K, McDonald S, Lasiuk G, McDonald S, et al. 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). Trials. 2014;15:72. doi: 10.1186/1745-6215-15-72.
48. Committee GEA. Australian clinical practice guidelines for depression and related disorders -- anxiety, bipolar disorder and puerperal psychosis -- in the perinatal period. A guideline for primary health care professionals. Melbourne: Beyondblue; 2011.
49. Spielberger CD. State-Trait Anxiety Inventory: Bibliography. 2nd ed. Palo Alto: Consulting Psychologists Press; 1989.
50. Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992;31(Pt 3):301-6.
51. Bergink V, Kooistra L, Lambregtse-van denBerg MP, Wijnen H, Bunevicius R, van Baar A, et al. Validation of the Edinburgh depression scale during pregnancy. J Psychosom Res. 2011;70(4):385-9. doi: 10.1016/j.jpsychores.2010.07.008.
52. Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, et al. Development and validation of a brief screening version of the childhood trauma questionnaire. Child Abuse Negl. 2003;27(2):169-90.
53. Thompson R. Development and validation of an internationally reliable short-form of the Positive and Negative Affect Schedule (PANAS). J Cross Cult Psychol. 2007;38(2):227-42. doi: 10.1177/0022022106297301.
54. Weissman A. Dysfunctional Attitude Scale: A validation study. Unpublished doctoral dissertation. 1979. Available at: http://repository.upenn.edu/cgi/viewcontent.cgi?article=2994&context=edissertations
55. Horne R. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1997;14(1):1-24. doi: 10.1080/08870449908407311.
56. Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999;47(6):555-67.
57. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727-36. doi: 10.1007/s11136-011-9903-x.
58. Quispel C, Bangma M, Kazemier BM, Steegers EAP, Hoogendijk WJG, Papatsonis DNM, et al. The role of depressive symptoms in the pathway of demographic and psychosocial risks to preterm birth and small for gestational age. Midwifery. 2014;30(8):919-25.
59. Bouwmans C, De Jong K, Timman R, Zijlstra-Vlasveld M, Van der Feltz-Cornelis C, Tan Swan S, et al. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013;13:217. doi: 10.1186/1472-6963-13-217.
60. van den Brink M, van den Hout WB, Stiggelbout AM, Putter H, van de Velde CJ, Kievit J. Self-reports of health-care utilization: diary or questionnaire? Int J Technol Assess Health Care. 2005;21(3):298-304.
61. Rosenbaum JF, Fava M, Hoog SL, Ascroft RC, Krebs WB. Selective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial. Biol Psychiatry. 1998;44(2):77-87.
62. Staufenbiel SM, Penninx BW, Spijker AT, Elzinga BM, van Rossum EF. Hair cortisol, stress exposure, and mental health in humans: a systematic review. Psychoneuroendocrinology. 2013;38(8):1220-35. doi: 10.1016/j.psyneuen.2012.11.015.
63. Einspieler C, Prechtl HF. Prechtl's assessment of general movements: a diagnostic tool for the functional assessment of the young nervous system. Ment Retard Dev Disabil Res Rev. 2005;11(1):61-7. doi: 10.1002/mrdd.20051.
64. Zuk L. Fetal and infant spontaneous general movements as predictors of developmental disabilities. Dev Disabil Res Rev. 2011;17(2):93-101. doi: 10.1002/ddrr.1104.
65. ICH guideline. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002662.pdf. Accessed on 8 Feb 2016.
66. Rescorla LA. Assessment of young children using the Achenbach System of Empirically Based Assessment (ASEBA). Ment Retard Dev Disabil Res Rev. 2005;11(3):226-37. doi: 10.1002/mrdd.20071.
67. Yonkers KA, Gotman N, Smith MV, Forray A, Belanger K, Brunetto WL, et al. Does antidepressant use attenuate the risk of a major depressive episode in pregnancy? Epidemiology. 2011;22(6):848-54.
68. Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, et al. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008;76(6):966-78. doi: 10.1037/a0013786.