A Prenatal Bonding Intervention for Pregnant Women With Depression

Not Applicable

Completed

Conditions: Depression
Pregnancy

Registration Number: NCT05628675

Lead Sponsor: King's College London

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change on Maternal Antenatal Attachment Scale (MAAS)	Baseline, up to 48-hours post-intervention, 1-month follow-up	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).

Secondary Outcome Measures

Name	Time	Method
Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ)	Baseline, up to 48-hours post-intervention, 1-month follow-up	The Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ; Pajulo et al., 2015) is a 14-item self-report questionnaire assessing expectant parents' abilities to think of their foetus as a separate individual with a developing temperament, personality and needs. The scale can be used during the second and third trimester of pregnancy. Higher total scores indicate stronger prenatal parental reflective functioning i.e. a better outcome (range 14-98).
Change on Edinburgh Postnatal Depression Scale (EPDS)	Baseline, up to 48-hours post-intervention, 1-month follow-up	The Edinburgh Postnatal Depression Scale (EPDS; Cox, Holden \& Sagovsky, 1987) is a 10-item self-report measure used to identify depression in women during the perinatal period. The scale was initially developed to screen for postnatal depression but has also been validated for use in antenatal populations (Murray \& Cox, 1990). Higher total scores indicate higher presence of depressive symptoms i.e. a worse outcome (range 0-30).