Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial

Elisabet Rondung, Elin Ternström, Ingegerd Hildingsson, Helen M Haines, Örjan Sundin, Johanna Ekdahl, Annika Karlström, Birgitta Larsson, Birgitta Segeblad, Rebecca Baylis, Christine Rubertsson, Elisabet Rondung, Elin Ternström, Ingegerd Hildingsson, Helen M Haines, Örjan Sundin, Johanna Ekdahl, Annika Karlström, Birgitta Larsson, Birgitta Segeblad, Rebecca Baylis, Christine Rubertsson

Abstract

Background: Although many pregnant women report fear related to the approaching birth, no consensus exists on how fear of birth should be handled in clinical care.

Objective: This randomized controlled trial aimed to compare the efficacy of a guided internet-based self-help program based on cognitive behavioral therapy (guided ICBT) with standard care on the levels of fear of birth in a sample of pregnant women reporting fear of birth.

Methods: This nonblinded, multicenter randomized controlled trial with a parallel design was conducted at three study centers (hospitals) in Sweden. Recruitment commenced at the ultrasound screening examination during gestational weeks 17-20. The therapist-guided ICBT intervention was inspired by the Unified protocol for transdiagnostic treatment of emotional disorders and consisted of 8 treatment modules and 1 module for postpartum follow-up. The aim was to help participants observe and understand their fear of birth and find new ways of coping with difficult thoughts and emotions. Standard care was offered in the three different study regions. The primary outcome was self-assessed levels of fear of birth, measured using the Fear of Birth Scale.

Results: We included 258 pregnant women reporting clinically significant levels of fear of birth (guided ICBT group, 127; standard care group, 131). Of the 127 women randomized to the guided ICBT group, 103 (81%) commenced treatment, 60 (47%) moved on to the second module, and only 13 (10%) finished ≥4 modules. The levels of fear of birth did not differ between the intervention groups postintervention. At 1-year postpartum follow-up, participants in the guided ICBT group exhibited significantly lower levels of fear of birth (U=3674.00, z=-1.97, P=.049, Cohen d=0.28, 95% CI -0.01 to 0.57). Using the linear mixed models analysis, an overall decrease in the levels of fear of birth over time was found (P≤ .001), along with a significant interaction between time and intervention, showing a larger reduction in fear of birth in the guided ICBT group over time (F1,192.538=4.96, P=.03).

Conclusions: Fear of birth decreased over time in both intervention groups; while the decrease was slightly larger in the guided ICBT group, the main effect of time alone, regardless of treatment allocation, was most evident. Poor treatment adherence to guided ICBT implies low feasibility and acceptance of this treatment.

Trial registration: ClinicalTrials.gov NCT02306434; https://ichgcp.net/clinical-trials-registry/NCT02306434 (Archived by WebCite at http://www.webcitation.org/70sj83qat).

Keywords: anxiety; cognitive behavioral therapy; fear of birth; internet-based; pregnancy.

Conflict of interest statement

Conflicts of Interest: None declared.

©Elisabet Rondung, Elin Ternström, Ingegerd Hildingsson, Helen M Haines, Örjan Sundin, Johanna Ekdahl, Annika Karlström, Birgitta Larsson, Birgitta Segeblad, Rebecca Baylis, Christine Rubertsson. Originally published in JMIR Mental Health (http://mental.jmir.org), 10.08.2018.

Figures

Figure 1
Figure 1
Flowchart of participants throughout the trial. ICBT: internet-based cognitive behavioral therapy SC: standard care.
Figure 2
Figure 2
Observed and estimated Fear of Birth Scale mean scores from screening until 1 year postpartum. ICBT: internet-based cognitive behavioral therapy; SC: standard care.

References

    1. Heimstad R, Dahloe R, Laache I, Skogvoll E, Schei B. Fear of childbirth and history of abuse: implications for pregnancy and delivery. Acta Obstet Gynecol Scand. 2006;85(4):435–40. doi: 10.1080/00016340500432507.
    1. Laursen M, Hedegaard M, Johansen C. Fear of childbirth: predictors and temporal changes among nulliparous women in the Danish National Birth Cohort. BJOG. 2008 Feb;115(3):354–60. doi: 10.1111/j.1471-0528.2007.01583.x. doi: 10.1111/j.1471-0528.2007.01583.x.
    1. Molgora S, Fenaroli V, Prino LE, Rollè L, Sechi C, Trovato A, Vismara L, Volpi B, Brustia P, Lucarelli L, Tambelli R, Saita E. Fear of childbirth in primiparous Italian pregnant women: The role of anxiety, depression, and couple adjustment. Women Birth. 2017 Jul 11;31(2):117–123. doi: 10.1016/j.wombi.2017.06.022.
    1. Handelzalts J, Becker G, Ahren M, Lurie S, Raz N, Tamir Z, Sadan O. Personality, fear of childbirth and birth outcomes in nulliparous women. Arch Gynecol Obstet. 2015 May;291(5):1055–62. doi: 10.1007/s00404-014-3532-x.
    1. Larsson B, Karlström A, Rubertsson C, Hildingsson I. The effects of counseling on fear of childbirth. Acta Obstet Gynecol Scand. 2015 Jun;94(6):629–36. doi: 10.1111/aogs.12634.
    1. Karlström A, Rådestad I, Eriksson C, Rubertsson C, Nystedt A, Hildingsson I. Cesarean section without medical reason, 1997 to 2006: a Swedish register study. Birth. 2010 Mar;37(1):11–20. doi: 10.1111/j.1523-536X.2009.00373.x.
    1. Sydsjö G, Sydsjö A, Gunnervik C, Bladh M, Josefsson A. Obstetric outcome for women who received individualized treatment for fear of childbirth during pregnancy. Acta Obstet Gynecol Scand. 2012 Jan;91(1):44–9. doi: 10.1111/j.1600-0412.2011.01242.x.
    1. O'Connell MA, Leahy-Warren P, Khashan AS, Kenny LC, O'Neill SM. Worldwide prevalence of tocophobia in pregnant women: systematic review and meta-analysis. Acta Obstet Gynecol Scand. 2017 Aug;96(8):907–920. doi: 10.1111/aogs.13138.
    1. Rondung E, Thomtén J, Sundin Ö. Psychological perspectives on fear of childbirth. J Anxiety Disord. 2016 Dec;44:80–91. doi: 10.1016/j.janxdis.2016.10.007.
    1. Huizink AC. Prenatal stress and its effect on infant development Internet. Utrecht: Utrecht University Repository; 2000. [2018-07-19]. .
    1. Hildingsson I, Haines H, Karlström A, Nystedt A. Presence and process of fear of birth during pregnancy-Findings from a longitudinal cohort study. Women Birth. 2017 Oct;30(5):e242–e247. doi: 10.1016/j.wombi.2017.02.003.
    1. Lukasse M, Vangen S, Øian P, Schei B. Fear of childbirth, women's preference for cesarean section and childhood abuse: a longitudinal study. Acta Obstet Gynecol Scand. 2011 Jan;90(1):33–40. doi: 10.1111/j.1600-0412.2010.01024.x.
    1. Nilsson C, Lundgren I, Karlström A, Hildingsson I. Self reported fear of childbirth and its association with women's birth experience and mode of delivery: a longitudinal population-based study. Women and Birth. 2012 Sep;25(3):114–21. doi: 10.1016/j.wombi.2011.06.001.
    1. Nilsson C, Hessman E, Sjöblom H, Dencker A, Jangsten E, Mollberg M, Patel H, Sparud-Lundin C, Wigert H, Begley C. Definitions, measurements and prevalence of fear of childbirth: a systematic review. BMC Pregnancy Childbirth. 2018 Dec 12;18(1):28. doi: 10.1186/s12884-018-1659-7.
    1. Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201–208. doi: 10.1034/j.1600-0412.2003.00114.x.
    1. Areskog B, Uddenberg N, Kjessler B. Fear of childbirth in late pregnancy. Gynecol Obstet Invest. 1981;12(5):262–6. doi: 10.1159/000299611.
    1. Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. Journal of Psychosomatic Obstetrics & Gynecology. 2009 Jul 07;19(2):84–97. doi: 10.3109/01674829809048501.
    1. Hofberg K, Brockington I. Tokophobia: An unreasoning dread of childbirth. Br J Psychiatry. 2000;176(01):83–85. doi: 10.1192/bjp.176.1.83.
    1. Huizink A, Mulder E, Robles de Medina P, Visser G, Buitelaar J. Is pregnancy anxiety a distinctive syndrome? Early Hum Dev. 2004 Sep;79(2):81–91. doi: 10.1016/j.earlhumdev.2004.04.014.
    1. Fenwick J, Gamble J, Nathan E, Bayes S, Hauck Y. Pre- and postpartum levels of childbirth fear and the relationship to birth outcomes in a cohort of Australian women. J Clin Nurs. 2009 Mar;18(5):667–77. doi: 10.1111/j.1365-2702.2008.02568.x.
    1. Melender HL. Experiences of Fears Associated with Pregnancy and Childbirth: A Study of 329 Pregnant Women. Birth. 2002 Jun;29(2):101–111. doi: 10.1046/j.1523-536X.2002.00170.x.
    1. Rouhe H, Salmela-Aro K, Gissler M, Halmesmäki E, Saisto T. Mental health problems common in women with fear of childbirth. BJOG. 2011 Aug;118(9):1104–11. doi: 10.1111/j.1471-0528.2011.02967.x. doi: 10.1111/j.1471-0528.2011.02967.x.
    1. Sjögren B. Reasons for anxiety about childbirth in 100 pregnant women. Journal of Psychosomatic Obstetrics & Gynecology. 2009 Jul 07;18(4):266–272. doi: 10.3109/01674829709080698.
    1. Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmäki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75–84. doi: 10.1111/1471-0528.12011. doi: 10.1111/1471-0528.12011.
    1. Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmäki E, Ryding E, Saisto T. Group psychoeducation with relaxation for severe fear of childbirth improves maternal adjustment and childbirth experience--a randomised controlled trial. J Psychosom Obstet Gynaecol. 2015 Nov;36(1):1–9. doi: 10.3109/0167482X.2014.980722.
    1. Saisto T, Toivanen R, Salmela-Aro K, Halmesmäki E. Therapeutic group psychoeducation and relaxation in treating fear of childbirth. Acta Obstet Gynecol Scand. 2006 Jan;85(11):1315–9. doi: 10.1080/00016340600756920.
    1. Toohill J, Fenwick J, Gamble J, Creedy D, Buist A, Turkstra E, Ryding EL. A randomized controlled trial of a psycho-education intervention by midwives in reducing childbirth fear in pregnant women. Birth. 2014 Dec;41(4):384–94. doi: 10.1111/birt.12136. doi: 10.1111/birt.12136.
    1. Larsson B, Karlström A, Rubertsson C, Hildingsson I. Counseling for childbirth fear - a national survey. Sex Reprod Healthc. 2016 Jun;8:82–7. doi: 10.1016/j.srhc.2016.02.008.
    1. National Institute for Heath and Care Excellence Social anxiety disorder: recognition, assessment and treatment. NICE clinical guideline 159. 2013. [2018-07-20]. .
    1. National Institute for Heath and Care Excellence Anxiety disorders. NICE quality standard 53. 2014. [2018-07-20]. .
    1. National Institute for Health and Clinical Excellence Obsessive-compulsive disorder and body dysmorphic disorder: treatment. NICE clinical guideline 31. 2005. [2018-07-20]. .
    1. National Institute for Health and Clinical Excellence Post-traumatic stress disorder: management. NICE clinical guideline 26. 2005. [2018-07-20]. .
    1. National Institute for Health and Clinical Excellence Generalized anxiety disorder and panic disorder in adults: management. NICE clinical guideline 113. 2011. [2018-07-20]. .
    1. National Institute for Health and Clinical Excellence Depression in adults: recognition and management. NICE clinical guideline 90. 2009. [2018-07-20]. .
    1. National Institute for Health and Care Excellence Antenatal and postnatal mental health: clinical management and service guidance. NICE clinival guideline 192. 2014. [2018-07-20]. .
    1. Pearl S, Norton P. Transdiagnostic versus diagnosis specific cognitive behavioural therapies for anxiety: A meta-analysis. J Anxiety Disord. 2017 Mar;46:11–24. doi: 10.1016/j.janxdis.2016.07.004.
    1. Arnberg FK, Linton SJ, Hultcrantz M, Heintz E, Jonsson U. Internet-delivered psychological treatments for mood and anxiety disorders: a systematic review of their efficacy, safety, and cost-effectiveness. PLoS One. 2014 May;9(5):e98118. doi: 10.1371/journal.pone.0098118.
    1. Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlöf E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1–18. doi: 10.1080/16506073.2017.1401115.
    1. Andrews G, Cuijpers P, Craske M, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.
    1. Andersson G, Titov N. Advantages and limitations of Internet-based interventions for common mental disorders. World Psychiatry. 2014 Feb;13(1):4–11. doi: 10.1002/wps.20083. doi: 10.1002/wps.20083.
    1. Nieminen K, Andersson G, Wijma B, Ryding E, Wijma K. Treatment of nulliparous women with severe fear of childbirth via the Internet: a feasibility study. J Psychosom Obstet Gynaecol. 2016;37(2):37–43. doi: 10.3109/0167482X.2016.1140143.
    1. Ternström E, Hildingsson I, Haines H, Karlström A, Sundin Ö, Ekdahl J, Segeblad B, Larsson B, Rondung E, Rubertsson C. A randomized controlled study comparing internet-based cognitive behavioral therapy and counselling by standard care for fear of birth - A study protocol. Sex Reprod Healthc. 2017 Oct;13:75–82. doi: 10.1016/j.srhc.2017.06.001.
    1. U-CARE. [2018-03-02].
    1. Hildingsson I, Nilsson C, Karlström A, Lundgren I. A longitudinal survey of childbirth-related fear and associated factors. J Obstet Gynecol Neonatal Nurs. 2011;40(5):532–43. doi: 10.1111/j.1552-6909.2011.01274.x.
    1. Haines H, Pallant J, Karlström A, Hildingsson I. Cross-cultural comparison of levels of childbirth-related fear in an Australian and Swedish sample. Midwifery. 2011 Aug;27(4):560–7. doi: 10.1016/j.midw.2010.05.004.
    1. Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: therapist guide. New York: Oxford University Press; 2011.
    1. Ellard K, Fairholme C, Boisseau C, Farchione T, Barlow D. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cognitive and Behavioral Practice. 2010 Feb;17(1):88–101. doi: 10.1016/j.cbpra.2009.06.002.
    1. Harris R. ACT made simple: an easy-to-read primer on acceptance and commitment therapy. Oakland, CA: New Harbinger Publications; 2009.
    1. Björklund U, Ellis J, Baummann Gustafsson B, Hammarström M, Lilliecreutz C, Nieminen K, Nordström L, Ryding E. Svensk Förening för Obstetrik och Gynekologi [Swedish Society of Obstetrics and Gynecology] 2017. [2018-07-20]. Förlossningsrädsla [Fear of Childbirth] .
    1. Ryding EL, Persson A, Onell C, Kvist L. An evaluation of midwives' counseling of pregnant women in fear of childbirth. Acta Obstet Gynecol Scand. 2003 Jan;82(1):10–17. doi: 10.1034/j.1600-0412.2003.820102.x.
    1. Haines HM, Pallant JF, Fenwick J, Gamble J, Creedy DK, Toohill J, Hildingsson I. Identifying women who are afraid of giving birth: A comparison of the fear of birth scale with the WDEQ-A in a large Australian cohort. Sex Reprod Healthc. 2015 Dec;6(4):204–10. doi: 10.1016/j.srhc.2015.05.002.
    1. Ternström E, Hildingsson I, Haines H, Rubertsson C. Higher prevalence of childbirth related fear in foreign born pregnant women--findings from a community sample in Sweden. Midwifery. 2015 Apr;31(4):445–50. doi: 10.1016/j.midw.2014.11.011.
    1. Ternström E, Hildingsson I, Haines H, Rubertsson C. Pregnant women's thoughts when assessing fear of birth on the Fear of Birth Scale. Women Birth. 2016 Jun;29(3):e44–9. doi: 10.1016/j.wombi.2015.11.009.
    1. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, CONSORT NPT Group CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 04;167(1):40–47. doi: 10.7326/M17-0046.
    1. Little R. A Test of Missing Completely at Random for Multivariate Data with Missing Values. Journal of the American Statistical Association. 1988 Dec;83(404):1198–1202. doi: 10.2307/2290157.
    1. Gueorguieva R, Krystal J. Move over ANOVA: progress in analyzing repeated-measures data and its reflection in papers published in the Archives of General Psychiatry. Arch Gen Psychiatry. 2004 Mar;61(3):310–7. doi: 10.1001/archpsyc.61.3.310.
    1. Lane P. Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches. Pharm Stat. 2008 Apr;7(2):93–106. doi: 10.1002/pst.267.
    1. Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data (Springer Series in Statistics) New York: Springer; 2000.
    1. Gumedze F, Dunne T. Parameter estimation and inference in the linear mixed model. Linear Algebra and its Applications. 2011 Oct;435(8):1920–1944. doi: 10.1016/j.laa.2011.04.015.
    1. Jacobson N, Truax P. Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. Journal of Consulting and Clinical Psychology. 1991;59(1):12–19. doi: 10.1037/0022-006X.59.1.12].
    1. Larsson B, Karlström A, Rubertsson C, Ternström E, Ekdahl J, Segebladh B, Hildingsson I. Birth preference in women undergoing treatment for childbirth fear: A randomised controlled trial. Women Birth. 2017 Dec;30(6):460–467. doi: 10.1016/j.wombi.2017.04.004.
    1. Garthus-Niegel S, Knoph C, von Soest T, Nielsen C, Eberhard-Gran M. The role of labor pain and overall birth experience in the development of posttraumatic stress symptoms: a longitudinal cohort study. Birth. 2014 Mar;41(1):108–15. doi: 10.1111/birt.12093.
    1. Beebe K, Lee K, Carrieri-Kohlman V, Humphreys J. The effects of childbirth self-efficacy and anxiety during pregnancy on prehospitalization labor. J Obstet Gynecol Neonatal Nurs. 2007;36(5):410–8. doi: 10.1111/j.1552-6909.2007.00170.x.
    1. Kjærgaard H, Wijma K, Dykes A, Alehagen S. Fear of childbirth in obstetrically low‐risk nulliparous women in Sweden and Denmark. Journal of Reproductive and Infant Psychology. 2008 Nov;26(4):340–350. doi: 10.1080/02646830802408498.
    1. Adams S, Eberhard-Gran M, Eskild A. Fear of childbirth and duration of labour: a study of 2206 women with intended vaginal delivery. BJOG. 2012 Sep;119(10):1238–46. doi: 10.1111/j.1471-0528.2012.03433.x. doi: 10.1111/j.1471-0528.2012.03433.x.
    1. Reck C, Zimmer K, Dubber S, Zipser B, Schlehe B, Gawlik S. The influence of general anxiety and childbirth-specific anxiety on birth outcome. Arch Womens Ment Health. 2013 Oct;16(5):363–9. doi: 10.1007/s00737-013-0344-0.
    1. Sydsjö G, Angerbjörn L, Palmquist S, Bladh M, Sydsjö A, Josefsson A. Secondary fear of childbirth prolongs the time to subsequent delivery. Acta Obstet Gynecol Scand. 2013 Feb;92(2):210–4. doi: 10.1111/aogs.12034.
    1. Hildingsson I. Swedish couples' attitudes towards birth, childbirth fear and birth preferences and relation to mode of birth - a longitudinal cohort study. Sex Reprod Healthc. 2014 Jun;5(2):75–80. doi: 10.1016/j.srhc.2014.02.002.
    1. Laursen M, Johansen C, Hedegaard M. Fear of childbirth and risk for birth complications in nulliparous women in the Danish National Birth Cohort. BJOG. 2009 Sep;116(10):1350–5. doi: 10.1111/j.1471-0528.2009.02250.x. doi: 10.1111/j.1471-0528.2009.02250.x.
    1. Ryding E, Lukasse M, Van Parys AS, Wangel A, Karro H, Kristjansdottir H, Schroll AM, Schei B, Bidens Group Fear of childbirth and risk of cesarean delivery: a cohort study in six European countries. Birth. 2015 Mar;42(1):48–55. doi: 10.1111/birt.12147.
    1. Nathan PE, Stuart SP, Dolan SL. Research on psychotherapy efficacy and effectiveness: Between Scylla and Charybdis? Psychological Bulletin. 2000;126(6):964–981. doi: 10.1037/0033-2909.126.6.964.
    1. Andersson G, Bergström J, Buhrman M, Carlbring P, Holländare F, Kaldo V, Nilsson-Ihrfelt E, Paxling B, Ström L, Waara J. Development of a New Approach to Guided Self-Help via the Internet: The Swedish Experience. Journal of Technology in Human Services. 2008 Jul 03;26(2-4):161–181. doi: 10.1080/15228830802094627.
    1. Socialstyrelsen [The National Board of Health and welfare] Graviditeter, Förlossningar och Nyfödda Barn, Medicinska Födelseregistret 1973–2014, Assisterad Befruktning 1991-2013 [Pregnancies, Deliveries and Newborn Infants, The Swedish Medical Birth Register 1973-2014, Assisted Reproduction Treatment 1991-2013] 2015. [2018-05-08]. .

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