CompletedNot Applicable

A Prenatal Bonding Intervention for Pregnant Women With Depression

United Kingdom21 participantsStarted 2022-11-17

Plain-language 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

Who can participate

Age range

18 Years – 99 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change on Maternal Antenatal Attachment Scale (MAAS)

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

Trial details

NCT IDNCT05628675

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-12

Results submitted2024-08-08

View on ClinicalTrials.gov More Depression trials