About the Trial
Trial Name: Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention (HMHB)
ClinicalTrials.gov ID: NCT03880032
Sponsor: Johns Hopkins Bloomberg School of Public Health
Completion Date: October 7, 2022.
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CBT Intervention During Pregnancy Decreases Probability of Developing Postpartum Anxiety, Depression
The CBT-based intervention, compared with routine pregnancy care, demonstrated reductions of 81% and 74% for depression and anxiety, respectively.
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Cognitive behavioral therapy (CBT)-based intervention for pregnant women with anxiety who are living in Pakistan significantly decreased the likelihood of developing moderate to severe anxiety, depression, or both 6 weeks after birth, according to the authors of a study published in Nature Medicine. The study authors noted that the CBT-based intervention may prove to be an effective method in preventing postpartum anxiety or depression in women who are living in low-resource areas.1
“In low-resource settings, it can be challenging for women to access mental health care due to a global shortage of trained mental health specialists,” said Joshua A. Gordon, MD, PhD, director of the National Institute of Mental Health, National Institutes of Health, in a press release. “This study shows that non-specialists could help to fill this gap, providing care to more women during this critical period."1
In this two-arm, single-blind, randomized phase 3 study, 755 pregnant women with symptoms of at least mild anxiety were randomly assigned to receive either standard of care pregnancy care (n = 375) or a cognitive behavioral therapy (CBT)-based intervention (n = 380). The CBT method included 6 intervention sessions in which participants learned to identify anxious thoughts and behaviors—for example, thoughts about potential miscarriage—and practiced replacing them with more positive and beneficial thoughts and behaviors. Of the 6 sessions, 5 were conducted during the early to middle stages of pregnancy, and the final session was held during the third trimester.1,2
The results indicated that approximately 9% and 12% of women in the CBT group had developed moderate to severe anxiety and depression, respectively, which was considerably favorable compared with the standard of care group, who experienced moderate to severe anxiety at 27% and depression at 41%. In addition, the investigators found 81% and 74% reductions in the odds of postnatal depression (aOR = 0.19, 95% CI 0.13–0.28) and of moderate to severe anxiety (aOR = 0.26, 95% CI 0.17–0.40), respectively. The primary end points of the study were major depression, generalized anxiety disorder, or both at 6 weeks after delivery; these end points were met, the study authors noted.1,2
“Postpartum depression not only harms mothers, it is also associated with poorer physical growth and delayed cognitive development in their children,” said Pamela J. Surkan, PHD, ScD, Johns Hopkins Bloomberg School of Public Health, in the press release. “The link between maternal and child health highlights the critical importance of developing effective ways to address postpartum anxiety and depression.”1
According to the investigators, prior research suggests that up to 30% of women in the Global South—South America, Africa, and most of southern Asia—report experiencing anxiety during pregnancy. Women who have anxiety during pregnancy are likely to have anxiety and depression postpartum, emphasizing a need for intervention during pregnancy; however, the investigators note that this can be challenging for women who live in low-income, low-resource areas with limited access to medical care.1
“In the future, we can build on these findings through implementation research. Having identified an intervention that works, the next step is to figure out the best ways to deliver effective treatment to the people who need it, bridging the gap between science and practice,” said Surkan in the press release.1
REFERENCES
National Institute of Mental Health. Intervention reduces likelihood of developing postpartum anxiety and depression by more than 70%. News release. February 26, 2024. Accessed March 1, 2024.
Surkan, PJ, Malik, A, Perin, J, et al. Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial. Nat Med (2024). doi:10.1038/s41591-024-02809-x
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