CClinicalTrials.gg
RecruitingNCT06237088Updated Feb 1, 2024

Mother-infant Connection Strategy Program

An interventional study of online mindfulness program and eight-week mindfulness programs in Psychological and Mother-Infant Interaction, sponsored by National Taipei University of Nursing and Health Sciences. Recruiting at 1 site in Taiwan. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.

Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Registered 11 months after the study started (first participant enrolled Jan 2023, registered Jan 2024).
  • Started Jan 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Psychological
  • Mother-Infant Interaction

Keywords

  • Mindfulness, Anxiety, Depression, Mother-Infant Interaction
03

In context

Lead sponsor

National Taipei University of Nursing and Health Sciences is the lead sponsor of 119 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Taking medication for diagnosing mental illness
  • With complicated or high-risk pregnancies
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
142 participants (estimated)

Study arms

  • 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

  • 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

  • No intervention
    care as usual

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

Interventions

  • Otheronline 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.

  • Othereight-week mindfulness programs

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

  2. 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

    Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

  3. 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"

    Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

  4. 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.

    Time frame: the follow-up at 2 , 4 months postpartum.

07

Study locations

1 of 1 sites recruiting
  • Wan-Lin Pan
    Taipei, 114, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06237088
Lead sponsor
National Taipei University of Nursing and Health Sciences
Responsible party
Wan-Lin Pan (Assistant Professor, National Taipei University of Nursing and Health Sciences) — Principal investigator
First posted
Feb 1, 2024
Start date
Jan 30, 2023
Primary completion
Jan 30, 2025 (estimated)
Completion
Jan 30, 2026 (estimated)
Last update
Feb 1, 2024

Study contacts

Wan-Lin Pan, PHD
Contact
wanlimp@gmail.com
886-2-28227101 ext. 3131
Wan-Lin Pan, PHD
principal investigator · assistant professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion