A Prenatal Bonding Intervention for Pregnant Women With Depression

NCT ID: NCT05628675

Last Updated: 2025-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-17

Study Completion Date

2023-07-12

Brief Summary

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The goal of this clinical trial is to test a group for pregnant women with depression that aims to help them build a stronger relationship with their unborn baby. The main questions it aims to answer are:

* Is the group acceptable to pregnant women with depression?
* Is it possible to run this group with pregnant women with depression?
* Could the group potentially impact bonding, parental reflective functioning and mood?

Participants will be asked to:

* attend the group (which lasts 90mins)
* complete questionnaires before and after the group, and 1 month later

Detailed Description

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Depression during pregnancy is a common mental health problem. Pregnant women with depression often continue to feel depressed after their baby is born, which can have several negative effects for both mother and child. For example, depressed mothers can find it harder to build a good relationship with their baby. Existing treatments for depression may not be sufficient to also improve the relationship between mother and baby. Depressed mothers may therefore need more specific help with connecting to their baby.

One promising new intervention is Baby CHAT. Baby CHAT is a single-session group that helps expectant parents learn about their unborn baby by viewing moving 4D ultrasound scans. It is believed that this will help parents to build a stronger relationship with their unborn baby. Baby CHAT has already been trialled with parents without any mental health problems, with promising results. This study aims to assess whether Baby CHAT is helpful for pregnant women with depression, collect data to inform future large-scale trials, and to develop the intervention from participants' feedback. The main research question asks: is Baby CHAT acceptable and feasible to deliver with pregnant women with depression?

Participants eligible to take part in the project will be people aged ≥18 years who are pregnant, between 20- and 34-weeks' gestation, and currently experiencing depressive symptoms. The project is taking place at an NHS site, with participants recruited from mental health and maternity services and online advertising. Participants will attend an online Baby CHAT group and complete online questionnaires at three time points (before and after Baby CHAT, and at one-month follow-up). The questionnaires will assess participants' relationship with their unborn baby, their ability to imagine their unborn baby as a separate person, and their level of depressive symptoms. The anticipated study end date is May 2023.

Conditions

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Depression Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-arm repeated measures
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally.

Group Type EXPERIMENTAL

Baby CHAT

Intervention Type OTHER

Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby.

Interventions

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Baby CHAT

Baby CHAT is an approximately 90-minute group intervention to be delivered during pregnancy. The group is comprised of psychoeducational material about a baby's social development after birth and while the baby is growing in the womb. Attendees are encouraged to think about when an infant's social development begins and consider whether this occurs before or after birth. Participants are then shown a video clip of Reissland et al.'s (2016) study showing 4D ultrasound images of foetuses mouthing in response to sounds that are presented to them outside the womb. During Baby CHAT, parents are encouraged to reflect on this information in the context of their own baby's development, including their likes and dislikes, routine and personality. The final section of the group involves generating ideas for social activities that parents can try with their baby prior to birth, such as singing to, massaging or reading to their baby.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Currently pregnant
2. Aged ≥18 years
3. Between 20- and 34-weeks' gestation
4. Currently experiencing depressive symptoms as identified by the Edinburgh Postnatal Depression Scale (EPDS)
5. Resident in or accessing services in a London borough served by South London \& Maudsley NHS Foundation Trust

Exclusion Criteria

1. Experiencing severe depression or current severe co-morbid diagnoses e.g. psychosis
2. Endorse 'yes, quite often' or 'sometimes' on question 10 of the Edinburgh Postnatal Depression Scale (EPDS; in the past 7 days, 'the thought of harming myself has occurred to me') at screening
3. Unable to complete informed consent and the questionnaires in English
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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South London and Maudsley NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca C Cockburn

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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302132

Identifier Type: OTHER

Identifier Source: secondary_id

R&D2022/056

Identifier Type: -

Identifier Source: org_study_id

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