Research paperA randomized controlled trial of ‘MUMentum Pregnancy’: Internet-delivered cognitive behavioral therapy program for antenatal anxiety and depression☆
Introduction
During pregnancy, approximately one in five women experience clinically significant symptoms of anxiety and depression, and one in six meet diagnostic criteria for an anxiety and/or major depressive disorder (MDD; Becker et al., 2016, Dennis et al., 2017). Antenatal anxiety and depression are robust predictors of postpartum depression (Austin et al., 2007, Milgrom et al., 2008), and if left untreated, are associated with a range of adverse outcomes for both the mother and infant (e.g., reduced antenatal care; increased risk of preterm birth, low birth weight, and later childhood emotional difficulties; Ding et al., 2014, Goodman and Tyer-Viola, 2010, Grote et al., 2010). Despite this, anxiety and depression during the antenatal period remain under-detected and under-treated (Biaggi et al., 2016, Kingston et al., 2015).
Effective face-to-face treatments exist (e.g., Milgrom et al., 2015), with cognitive behavioural therapy (CBT) being the recommended psychological treatment for mild to moderate anxiety and depression during pregnancy (Austin et al., 2017, NICE 2014). However, there are a range of social, geographical, and logistical barriers that limit access and engagement with existing services (Kingston et al., 2015, Kopelman et al., 2008, Woolhouse et al., 2009). Delivering CBT via the internet (iCBT) provides an alternate option to face-to-face services that could improve treatment uptake in this population. iCBT is a well-established treatment for anxiety and depression in the general adult population (Andrews et al., 2018) and is effective in postpartum populations (Milgrom et al., 2016). iCBT offers several benefits over face-to-face psychotherapy including reduced out-of-pocket cost, increased privacy and convenience, and greater treatment fidelity. iCBT has been shown to be as effective as face-to-face CBT for some disorders (Andersson et al., 2013, Carlbring et al., 2018).
Whilst the evidence-base for iCBT for anxiety and depression is robust in the general adult population, support for its use within the antenatal period is in its infancy. First, most research to-date has focused only on the postpartum period (see Lau et al., 2017). These studies report moderate to large reductions in postpartum depressive symptoms. Only one RCT has evaluated iCBT for antenatal MDD: Forsell et al. (2017)) found large effect size reductions in depressive symptoms relative to treatment as usual (TAU) (Hedges’ g = 1.21). It is unclear whether these findings generalize to a wide range of pregnant women, particularly those who may not meet diagnostic criteria for MDD, but still experience disabling depressive symptoms.
Secondly, no study has investigated the effects of iCBT for the treatment of antenatal generalised anxiety disorder (GAD) symptoms or for the treatment of comorbid GAD and MDD. This is concerning given that these disorders frequently co-occur and that antenatal anxiety affects a comparable number of expectant mothers and results in similar adverse outcomes as depression (Dennis et al., 2017, Grigoriadis et al., 2011). Although no study has examined the effects of iCBT in treating GAD in the antenatal period, Nieminen et al.(2016)) evaluated the feasibility of iCBT for pregnant women with severe fear of childbirth in an open pilot trial, and demonstrated large and significant reductions in their fears (Cohen's d = 0.95). iCBT for postpartum depression appears to have a positive but small impact on anxiety symptoms relative to control conditions (Cohen's d = 0.36; Lau et al., 2017). This is an important area of investigation given the treatment of perinatal anxiety in the broader literature has also received very little attention (Goodman and Tyer-Viola, 2010, Loughnan et al., 2018b).
Third, no study has examined the effects of brief, and/or unguided (i.e., no therapist or clinician support or coaching) iCBT for antenatal symptoms of GAD and/or MDD. The evaluation of brief unguided interventions is important within the context of the antenatal period particularly given shorter programs may be more appealing to busy women, and unguided iCBT programs offering greater scalability and cost-effectiveness for large-scale dissemination. Finally, no study has explored the impact of iCBT beyond symptom change to other antenatal factors, such as maternal bonding. The development of a relationship with the unborn child is thought to be a key development task in successful psychological adjustment to pregnancy, and is associated with health behaviours of the mother and wellbeing of the child before and after birth (Dubber et al., 2015, Van den Bergh and Simons, 2009). However, little is known about the effects of anxiety and depression on the mother's bonding during pregnancy. These are important areas of investigation if we are to maximise treatment benefits for both the mother and infant.
To address these gaps in the literature, we developed a brief unguided iCBT program, “MUMentum Pregnancy”, designed to target symptoms of anxiety and depression during pregnancy (Loughnan et al., 2018a). This study aimed to test the efficacy and acceptability of this program compared to TAU control group. We hypothesised that the MUMentum Pregnancy program would: (1) significantly reduce symptoms of anxiety, depression, and general psychological distress; (2) be significantly more effective at reducing these symptoms than TAU; (3) improve maternal feelings of emotional bonding to the fetus and maternal quality of life; and (4) be acceptable to participants.
Section snippets
Design
A CONSORT-revised 2010 compliant (Schulz et al., 2010) randomised, controlled superiority trial (RCT) design was used to compare the MUMentum Pregnancy program to a TAU control. The trial protocol was approved by the Human Research Ethics Committee of St. Vincent's Hospital, Sydney (HREC/16/SVH/63) and is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000560493). The protocol for this study has been published previously (Loughnan et al., 2018a).
Participant recruitment
Prior to the
Baseline characteristics
Participant flow through the trial is depicted in Fig. 1. A total of 409 women applied, with 87 randomised to iCBT (n = 43) or TAU (n = 44). Of those women, 77 (iCBT: n = 36, TAU: n = 41) completed baseline questionnaires and were included in the analysis.
Participants’ demographics and baseline clinical characteristics are shown in Table 2. In general, the women were aged 31.61 years (SD = 4.00; R = 23–40) and 21.66 weeks gestational age (SD = 5.93). The majority of women were multiparous
Discussion
The current study examined the efficacy and acceptability of an internet-delivered CBT program, the MUMentum Pregnancy program for antenatal anxiety and depression compared to TAU. We found that a brief unguided iCBT program reduced psychological distress, anxiety and depressive symptom severity from pre- to post-treatment in an Australian sample of pregnant women, and was superior to usual care in reducing distress and generalised anxiety symptoms. The MUMentum Pregnancy program resulted in
Conclusion
This study provides preliminary support for the efficacy and acceptability of brief, unguided iCBT for anxiety and depression in pregnant women, and provides a range of future research directions. Although we found iCBT led to larger improvements in distress and anxiety than the control group, only small differences were found in depressive symptom severity which appeared to improve at a similar rate in the iCBT group to usual care. Further RCTs are required to replicate our findings and
Conflict of interest
All authors declare that they have no conflict of interest.
Competing interests
All authors declare that they have no competing interests.
Authors’ contributions
SL, JN, HH, AM, and GA designed the study and developed the intervention. AS supervised all study participants. All authors were involved in the development or evaluation of the program and have contributed to and approved the final version of the manuscript for publication.
Funding
This research project was supported by the HCF Research Foundation in the form of a research grant awarded to the Clinical Research Unit for Anxiety and Depression
Acknowledgement
We gratefully acknowledge the pregnant women who participated in the study, and the health professionals who promoted our research study.
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Cited by (0)
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Trial Registration
Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000560493.