Clinical trial NCT05628675: A Prenatal Bonding Intervention for Pregnant Women With Depression
Official title: Feasibility of a Psychoeducational Group Intervention to Improve Parental Reflective Functioning and Bonding in Prenatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Pregnancy
Keywords: Prenatal Bonding
Reflective Functioning
Maternal-Foetal Attachment
Mentalisation
Prenatal Depression
Perinatal Depression
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2022-11-29
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm repeated measures
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on Maternal Antenatal Attachment Scale (MAAS)
timeFrame: Baseline, up to 48-hours post-intervention, 1-month follow-up
Secondary outcomes:
measure: Change on Prenatal Parental Reflective Functioning Questionnaire (P-PRFQ)
timeFrame: Baseline, up to 48-hours post-intervention, 1-month follow-up
measure: Change on Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, up to 48-hours post-intervention, 1-month follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Rebecca C Cockburn
role: PRINCIPAL_INVESTIGATOR
References: