A Prenatal Bonding Intervention for Pregnant Women With Depression

NCT05628675 | Completed Results

• 2 other identifiers: R&D2022/056302132
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Pregnancy

Keywords

Prenatal Bonding; Reflective Functioning; Maternal-Foetal Attachment; Mentalisation; Prenatal Depression; Perinatal Depression

Outcome Measures

Primary Outcomes (1)

• Change on Maternal Antenatal Attachment Scale (MAAS)

  The Maternal Antenatal Attachment Scale (MAAS; Condon, 1993) is a self-report questionnaire for expectant mothers, designed to assess the maternal-foetal attachment during pregnancy. The scale consists of 19 items on a 5-point Likert scale assessing women's attitudes, feelings and behaviours towards their foetus. Higher total scores indicate stronger prenatal bonding i.e. a better outcome (range 19-95).

  Baseline, up to 48-hours post-intervention, 1-month follow-up

Secondary Outcomes (2)

• Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ)

  Baseline, up to 48-hours post-intervention, 1-month follow-up

• Change on Edinburgh Postnatal Depression Scale (EPDS)

  Baseline, up to 48-hours post-intervention, 1-month follow-up

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Baby CHAT

Interventions

Baby CHAT 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Experiencing severe depression or current severe co-morbid diagnoses e.g. psychosis
• 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
• Unable to complete informed consent and the questionnaires in English

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

As this was a small, uncontrolled feasibility study, it is not possible to conclude that any observed changes in prenatal bonding, parental RF or depressive symptomatology were due to the intervention. Future research is needed with larger sample sizes, powered to test for statistically significant changes, and utilising a control condition. A comparison group would allow for greater control of confounding variables.

Results Point of Contact

• Title: Dr Rebecca Cockburn
• Organization: King's College London/South London and Maudsley NHS

rebecca.cockburn@kcl.ac.uk

02032288800

Study Officials

• Rebecca C Cockburn

  King's College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm repeated measures

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 29, 2022
• Study Start: November 17, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: June 25, 2025
• Results First Posted: June 25, 2025

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)