Care4mommies in Action: A Compassion-based Intervention

NCT07611175 | Recruiting

• 1 other identifier: 2023.11605.PEX
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

pregnancy; mother-baby bonding; Compassion focused intervention; self-compassion

Outcome Measures

Primary Outcomes (3)

• Parent Bonding Questionnaire (PBQ)

  The Parent Bonding Questionnaire is a 12-item self-reported questionnaire that assesses Mother-baby bonding. The responses are given on a 6-point Likert scale (ranging from 0 = 'Never' to 5 = 'Always'). Scores range from 0 to 60. Items with negative valence will be reverse-coded so that higher scores reflect better quality of mother-infant bonding.

  three-months follow-up T3 (3 months postpartum)

• Self- Compassion scale from the Compassionate Engagement and Action Scales (CEAS-SC)

  The Self- Compassion scale from the Compassionate Engagement and Action Scales is an 11-item self-reported questionnaire that assesses self-compassion engagement and actions. The responses are given on a 10-point Likert scale (from 1 = "never" to 10 = "always"). Scores range from 11 to 110, with higher scores reflecting more self-compassion abilities.

  1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).

• Caring shame and guilt scale- Adapted (CSGS)

  Caring shame and guilt scale- Adapted is a 12-item self-reported questionnaire that assesses shame and guilt about caring. The responses are given on a 5-point Likert scale (ranging from 1 = "Not at all typical/characteristic of me" to "0 = "Extremely typical/characteristic of me"). Scores range from 0 to 48, with higher scores reflecting higher levels of shame and guilt feelings.

  three-months follow-up T3 (3 months postpartum)

Secondary Outcomes (3)

• Fears of Self-Compassion Scale from the Fears of Compassion scales (FSC)

  1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).

• Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCSR)

  1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).

• Mental health continuum - Short-form (MHC-SF)

  1 week before intervention (T1); immediately after the intervention (T2) and at three-months follow-up (T3; 3 months postpartum).

Study Arms (2)

Care4mommies Group

EXPERIMENTAL

Care4mommies is a manualized in-person, compassion-based intervention for pregnant women based on Compassion Focused Therapy (CFT). It comprises 5 weekly sessions of 2h/each aimed to promote mothers' well-being and mother-baby bonding

Behavioral: Care4mommies; Other: Birth preparation courses

Treatment as Usual

ACTIVE COMPARATOR

Usual birth preparation courses delivered by nurses that include theoretical and practical group classes to prepare women for birth and for the challenges of postpartum

Other: Birth preparation courses

Interventions

Care4mommies BEHAVIORAL

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

Care4mommies Group

Birth preparation courses OTHER

Birth preparation courses provided by the ULS Alto-Ave

Also known as: Treatment as Usual

Care4mommies Group; Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• being between 26 and 33 weeks into a single-fetus pregnancy,
• being fluent in Portuguese

You may not qualify if:

• currently receiving another psychological intervention

Sponsors & Collaborators

• Portucalense University: lead
• Aveiro University: collaborator
• Unidade Local de Saúde do Alto Ave, EPE: collaborator

Study Sites (1)

Portucalense University

Porto, Porto District, 4200-072, Portugal

RECRUITING

Related Publications (1)

• Vagos P, Mateus V, Silva J, Araujo V, Xavier A, Palmeira L. Mother-infant bonding in the first nine months postpartum: the role of mother's attachment style and psychological flexibility. J Reprod Infant Psychol. 2025 Mar;43(2):472-486. doi: 10.1080/02646838.2023.2242379. Epub 2023 Jul 31.

  PMID: 37525320 BACKGROUND

Related Links

• Project's website

MeSH Terms

Interventions

Therapeutics

Study Officials

• Lara N Palmeira, PhD

  Portucalense University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara N Palmeira, PhD

CONTACT

+351 225 572 000; larap@upt.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research fellow who will perform the data analysis of the intervention outcome(s) will be blinded to participants' group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 28, 2026
• Study Start: January 2, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)