Mother-infant Connection Strategy Program

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

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

Study Overview

• Status: Recruiting
• Conditions: Psychological; Mother-Infant Interaction
• Intervention / Treatment: Other: eight-week mindfulness programs; Other: online mindfulness program

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wan-Lin Pan, PHD; Phone Number: 3131 886-2-28227101; Email: wanlimp@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • Wan-Lin Pan
    • Contact: WAN-LIN PAN, PHD; Phone Number: 0933710737; Email: wanlimp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: eight-week mindfulness programs; The intervention consists of 2.5-hour classes per week over a period of eight weeks.	Other: eight-week mindfulness programs; The intervention consists of 2.5-hour classes per week over a period of eight weeks.
Experimental: 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.	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.
No Intervention: care as usual; Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: Wan-Lin Pan, PHD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness, Anxiety, Depression, Mother-Infant Interaction
• Other Study ID Numbers: 111-E-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No