Mother-infant Connection Strategy Program

Psychological Clinical Trial

Official title:

Mother-infant Connection Strategy Program: Impact on Psychological Distress and Mother-infant Bonding in Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237088
• Other study ID #: 111-E-21
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: January 30, 2026

Study information

• Verified date: January 2024
• Source: National Taipei University of Nursing and Health Sciences
• Contact: Wan-Lin Pan, PHD
• Phone: 886-2-28227101
• Email: wanlimp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluated the long-term effects of an online mindfulness-based program on the psychological distress and mother-infant bonding of women

Description:

The aim of this study was to test the efficacy of an online mindfulness program in reducing women's perceived stress, anxiety, depression, and in enhancing mindfulness and mother-infant bonding compared to a control group. The investigators hypothesize that the use of an online mindfulness program or an eight-week mindfulness program by the two experimental groups will lead to improved mood symptoms and mother-infant bonding compared with the control group.

A randomized controlled trial comparing three groups of healthy, singleton pregnant women was conducted using the Random Allocation Software (Saghaei, 2004). We used G-Power 3.1.9 for Windows to analyze the minimum effect size that would be statistically significant with an 80% probability, using an alpha error probability of 0.05 in the "ANOVA: Repeated measures, between factors" option. We inputted 3 for the number of groups, 4 for the number of measurements, 0.5 for the correlation between repeated measures, and factored in a 20% attrition rate. There are 41 women in each group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: January 30, 2026
• Est. primary completion date: January 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects were at the age over 18

• Could speak and read Chinese fluently

• Willing and be ale to attend the education program

Exclusion Criteria:

• Taking medication for diagnosing mental illness

• With complicated or high-risk pregnancies

Related Conditions & MeSH terms

• Mother-Infant Interaction
• Psychological

Intervention

Other:
• online mindfulness program
The intervention includes an eight-week internet-based mindfulness program. The program introduces participants to a new mindfulness topic every week. These topics are heavily inspired by the eight-week mindfulness programs.
• eight-week mindfulness programs
The intervention consists of 2.5-hour classes per week over a period of eight weeks.

Locations

Country	Name	City	State
Taiwan	Wan-Lin Pan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety	The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety.	baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
Primary	depression	Edinburgh Perinatal Depression Scale, that was 10-question questionnaire provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total score	baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
Primary	mindfulness	The Five Facet Mindfulness Questionnaire, that was 39-item is based on factor analysis. The five facets of the FFMQ include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scoring uses a 5-point Likert scale, with 1 representing "never or very rarely true" and 5 representing "very often or always true"	baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
Primary	mother-infant bonding	The Postpartum Bonding Questionnaire, that was 25 items, with four factors. The first factor was labelled general emotional factor, the second anger towards and rejection of baby; the third infant-focus anxiety; and the fourth, risk of abuse.	the follow-up at 2 , 4 months postpartum.