A Prenatal Bonding Intervention for Pregnant Women With Depression

Depression Clinical Trial

Official title:

Feasibility of a Psychoeducational Group Intervention to Improve Parental Reflective Functioning and Bonding in Prenatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628675
• Other study ID #: R&D2022/056
• Secondary ID: 302132
• Status: Completed
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: August 2022
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Participants will be asked to:

• attend the group (which lasts 90mins)

• complete questionnaires before and after the group, and 1 month later

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pregnancy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on Maternal Antenatal Attachment Scale (MAAS)	The 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.	Baseline, up to 48-hours post-intervention, 1-month follow-up
Secondary	Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ)	The 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.	Baseline, up to 48-hours post-intervention, 1-month follow-up
Secondary	Change on Edinburgh Postnatal Depression Scale (EPDS)	The 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).	Baseline, up to 48-hours post-intervention, 1-month follow-up