Trial results for a prenatal bonding intervention for pregnant women with Depression were posted on ClinicalTrials.gov on 2025-06-25, with 21 participants enrolled.
Background
Depression during pregnancy can impact maternal well-being and the developing relationship with the unborn child. This trial investigated a group intervention designed for pregnant women with depression, aiming to foster a stronger bond with their unborn baby. The intervention sought to assess its acceptability, feasibility, and potential impact on maternal bonding, parental reflective functioning, and mood.
Trial design
This completed study, designated as Phase NA, enrolled 21 participants with Depression and Pregnancy. The trial evaluated a group intervention for pregnant women with depression, which aimed to help them build a stronger relationship with their unborn baby. Participants attended a 90-minute group session and completed questionnaires at baseline, post-group, and one month later.
Key results
The trial results included measurements for maternal antenatal attachment, prenatal parental reflective functioning, and depression scores:
- Maternal Antenatal Attachment Scale (MAAS): Mean scores for the Intervention group increased from 69.7 (Standard Deviation: 9.1) at Time 1 to 75.9 (Standard Deviation: 8.0) at Time 3.
- Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ): Mean scores for the Intervention group increased from 60.7 (Standard Deviation: 15.1) at Time 1 to 67.1 (Standard Deviation: 10.1) at Time 3.
- Edinburgh Postnatal Depression Scale (EPDS): Mean scores for the Intervention group decreased from 17.3 (Standard Deviation: 3.0) at Time 1 to 10.4 (Standard Deviation: 3.6) at Time 3.
Key analyses reported effect sizes (Hedge's g):
- Effect size calculation from Time 1 to Time 2 on MAAS was 0.32 (95.0% CI: -0.33 to 0.96).
- Effect size calculation from Time 1 to Time 3 on MAAS was 0.72 (95.0% CI: 0.02 to 1.42).
- Effect size calculation from Time 1 to Time 2 on P-PRFQ was 0.36 (95.0% CI: -0.29 to 1.01).
- Effect size calculation from Time 1 to Time 3 on P-PRFQ was 0.49 (95.0% CI: -0.2 to 1.17).
- Effect size calculation from Time 1 to Time 2 on EPDS was 1.48 (95.0% CI: 0.75 to 2.21).
- Effect size calculation from Time 1 to Time 3 on EPDS was 2.08 (95.0% CI: 1.28 to 2.88).
What this means
The results suggest that the prenatal bonding intervention may have a positive impact on mood and maternal-fetal bonding in pregnant women with depression. Notably, the Edinburgh Postnatal Depression Scale (EPDS) scores showed a substantial decrease from a mean of 17.3 at Time 1 to 10.4 at Time 3, corresponding to a strong effect size (Hedge's g) of 2.08 (95.0% CI: 1.28 to 2.88) from Time 1 to Time 3. This indicates a clinically meaningful improvement in depressive symptoms. Additionally, scores on the Maternal Antenatal Attachment Scale (MAAS) increased from a mean of 69.7 to 75.9, with an effect size of 0.72 (95.0% CI: 0.02 to 1.42) from Time 1 to Time 3, suggesting enhanced maternal attachment. Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) scores also showed an increase from a mean of 60.7 to 67.1, with an effect size of 0.49 (95.0% CI: -0.2 to 1.17) from Time 1 to Time 3. These findings, while from a small cohort of 21 participants, indicate the potential for this intervention to improve psychological well-being and bonding in this vulnerable population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05628675, titled "A Prenatal Bonding Intervention for Pregnant Women With Depression", were posted on 2025-06-25 on clinicaltrials.gov.