Mother-infant Connection Strategy Program

NCT06237088 | Unknown DMC

• 1 other identifier: 111-E-21
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psychological; Mother-Infant Interaction

Keywords

Mindfulness, Anxiety, Depression, Mother-Infant Interaction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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.

Study Arms (3)

eight-week mindfulness programs

ACTIVE COMPARATOR

The intervention consists of 2.5-hour classes per week over a period of eight weeks.

Other: eight-week mindfulness programs

online mindfulness program

EXPERIMENTAL

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

care as usual

NO INTERVENTION

Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum.

Interventions

online mindfulness program OTHER

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.

online mindfulness program

eight-week mindfulness programs OTHER

The intervention consists of 2.5-hour classes per week over a period of eight weeks.

eight-week mindfulness programs

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects were at the age over 18
• Could speak and read Chinese fluently
• Willing and be ale to attend the education program

You may not qualify if:

• Taking medication for diagnosing mental illness
• With complicated or high-risk pregnancies

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Wan-Lin Pan

Taipei, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Wan-Lin Pan, PHD

  assistant professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-Lin Pan, PHD

CONTACT

886-2-28227101; wanlimp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: January 30, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

TW (1)