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RECRUITING
NCT07611175
NA

Care4mommies in Action: A Compassion-based Intervention

Sponsor: Portucalense University

View on ClinicalTrials.gov

Summary

Becoming a mother is a life-changing event that many experience as a time of joy and affection. However, it can also be a period of great vulnerability and uncertainty with the potential to hinder the mother's well-being and bonding with the baby, and undermine the child's later emotional, social, and cognitive development. The mothers' emotional regulation skills, namely self-compassion, may be useful in protecting the mother and the mother-baby bonding, making them a valuable target of intervention during the perinatal period and a potential protective factor for mental health. Although compassion-based interventions (CBIs) have been proven effective in promoting well-being and reducing mental health difficulties across diverse populations, including the perinatal period, evidence of their impact on maternal well-being and the mother-baby bond remains limited. Thus, the research team propose to explore the acceptability, feasibility, and preliminary efficacy of a CBI during pregnancy on mothers' compassion abilities, and consequent impact on well-being and quality of mother-baby bonding at postpartum. This pilot cluster randomised trial addresses the research question of 'Does the Care4mommies intervention work to promote mothers' compassion and higher quality of the mother-baby bonding?' Participants will be mothers enrolled in group birth preparation courses (i.e., TAU); those groups will be randomly allocated to Care4mommies plus TAU or TAU only and assessed at pre-intervention and post-intervention(prepartum), and 3-month follow-up(postpartum). At pre- and postintervention, participants will be asked to provide self-reported information on self-compassion, shame and guilt about caring, maternal-fetal attachment, fear of self-compassion, self-criticism, and mental health. At post-intervention, they will also be asked to appraise data collection procedures and the implementation feasibility of the Care4mommies; at follow-up, they will be asked to report on their bonding to their baby. Researchers expect that participants in the Care4mommies plus TAU condition will report significant gains at post-intervention and sustain them until follow-up, both in relation to the mother and in mother-baby bonding, compared to the TAU group. Also it is expected that changes in self-compassion-related variables will explain changes in mother-fetal attachment and postpartum mother-infant bonding.

Official title: Care4mommies in Action: Promoting Maternal Psychological Adjustment in the Perinatal Period

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2026-01-02

Completion Date

2026-12-08

Last Updated

2026-05-28

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Care4mommies

Compassion-focused Therapy based psychological group intervention aimed to cultivate compassion abilities to deal with the challenges of the perinatal period.

OTHER

Birth preparation courses

Birth preparation courses provided by the ULS Alto-Ave

Locations (1)

Portucalense University

Porto, Porto District, Portugal