Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jun 25, 2019
Open Peer Review Period: Jun 28, 2019 - Aug 3, 2019
Date Accepted: Dec 16, 2019
(closed for review but you can still tweet)
“MamaKits online”: a randomised controlled trial to assess the effectiveness of a guided internet-based tool for the treatment of depression and anxiety in pregnancy
ABSTRACT
Background:
Pregnant women with symptoms of depression or anxiety often do not receive adequate treatment. Facing the high incidence of these symptoms in pregnancy and their impact on pregnancy outcomes this is a matter of utmost importance. Guided internet self-help treatment may be of use to disseminate appropriate treatment more easily.
Objective:
To examine the effectiveness of a guided internet intervention (MamaKits online)for pregnant women with moderate to severe anxiety or depressive symptoms. Assessments took place at post intervention (T1), at 36 weeks of pregnancy (T2) and six weeks postpartum (T3). We also explored effects on pregnancy outcomes 6 weeks postpartum.
Methods:
We performed a randomized controlled trial (RCT) in which pregnant women (< 30 weeks) with depressive symptoms above threshold [i.e. Center for Epidemiological Studies Depression scale (CES-D) > 16] and/ or anxiety above threshold [i.e. Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) > 8] were randomized to (1) MamaKits online, or (2) treatment as usual (control condition). Participants were recruited through general media, flyers in prenatal care waiting rooms, by obstetricians and midwives. MamaKits online is a five-week guided internet intervention based on Problem Solving Treatment (iPST). Guidance was delivered by trained Master students in Psychology. Outcomes were based on online self-report. People in the control condition were allowed to receive the intervention after the last assessment (six weeks postpartum).
Results:
We included 159 women (79 MamaKits online; 80 control). 37 women (47%) completed the intervention. Both groups showed a substantial decrease in affective symptoms on the CES-D, HADS-A and EPDS over time. The intervention group showed more decrease in affective symptoms than the control group, between-group effect sizes were small to medium (Cohen’s d at T3 0.45, 0.21 and 0.23, respectively) and statistically not significant. There was no difference in occurrence of any negative pregnancy outcome between the two groups (² (1)= 0.081; P=.78). Completer analysis revealed no differences in outcome between the treatment completers and the control group. The trial was terminated early for reason of futility based on the results of an interim analysis, which we performed because of inclusion problems.
Conclusions:
Our study did not show a significant higher reduction in affective symptoms in the internet intervention condition in comparison to the control condition. There was also no difference in, pregnancy outcomes. Future research should examine for which women these interventions might be effective or if changes in the (internet) intervention might make the intervention more effective. Clinical Trial: Netherlands Trial Register number 4321
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.