A Prenatal Bonding Intervention for Pregnant Women With Depression

Sponsor

King's College London (Other)

Overall Status

Recruiting

CT.gov ID

NCT05628675

Collaborator

South London and Maudsley NHS Foundation Trust (Other)

Enrollment

Location

Arm

5.4

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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?

Participants will be asked to:

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

Condition or Disease	Intervention/Treatment	Phase
Depression Pregnancy	Other: Baby CHAT	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm repeated measuresSingle-arm repeated measures

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 17, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Single-session 90-minute psychoeducational group ("Baby CHAT") delivered antenatally.	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.

Arm

Intervention/Treatment

Experimental: Intervention

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

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ) [Baseline, up to 48-hours post-intervention, 1-month follow-up]
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.
Change on Edinburgh Postnatal Depression Scale (EPDS) [Baseline, up to 48-hours post-intervention, 1-month follow-up]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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