Care4mommies in Action: A Compassion-based Intervention
NCT07611175 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-05-28
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.
Conditions
- Pregnancy Related
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
Sponsors & Collaborators
-
Aveiro University
collaborator OTHER -
Unidade Local de Saúde do Alto Ave, EPE
collaborator OTHER -
Portucalense University
lead OTHER
Principal Investigators
-
Lara N Palmeira, PhD · Portucalense University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-02
- Primary Completion
- 2026-09-02
- Completion
- 2026-12-08
Countries
- Portugal
Study Locations
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