NCT07611175 Care4mommies in Action: A Compassion-based Intervention
| NCT ID | NCT07611175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Portucalense University |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2026-09-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2026-01-02 with a primary completion date of 2026-09-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * being between 26 and 33 weeks into a single-fetus pregnancy, * being fluent in Portuguese Exclusion Criteria: * currently receiving another psychological intervention
Contact & Investigator
Lara N Palmeira, PhD
PRINCIPAL INVESTIGATOR
Portucalense University
Frequently Asked Questions
Who can join the NCT07611175 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 49 Years, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07611175 currently recruiting?
Yes, NCT07611175 is actively recruiting participants. Contact the research team at larap@upt.pt for enrollment information.
Where is the NCT07611175 trial being conducted?
This trial is being conducted at Porto, Portugal.
Who is sponsoring the NCT07611175 clinical trial?
NCT07611175 is sponsored by Portucalense University. The principal investigator is Lara N Palmeira, PhD at Portucalense University. The trial plans to enroll 96 participants.