PsychologicalNCT06237088
Mother-infant Connection Strategy Program
A study testing online mindfulness program and eight-week mindfulness programs in people with Psychological and Mother-Infant Interaction, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological, Mother-Infant Interaction
- What is being tested?
- online mindfulness program and eight-week mindfulness programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jan 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects were at the age over 18
- Could speak and read Chinese fluently
- Willing and be ale to attend the education program
Who cannot join
- Taking medication for diagnosing mental illness
- With complicated or high-risk pregnancies
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Wan-Lin Pan
Taipei, 114
WAN-LIN PAN, PHD, 0933710737, wanlimp@gmail.com
About this study
Official title: 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
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.
- Conditions
- Psychological, Mother-Infant Interaction
- Being tested
- online mindfulness program, eight-week mindfulness programs
- Keywords
- Mindfulness, Anxiety, Depression, Mother-Infant Interaction
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mindfulness programOther
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 programsOther
The intervention consists of 2.5-hour classes per week over a period of eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| eight-week mindfulness programs | Active comparator | The intervention consists of 2.5-hour classes per week over a period of eight weeks. Receives: 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. Receives: Other: online mindfulness program |
| care as usual | No intervention | Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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"
Measured: 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.
Measured: the follow-up at 2 , 4 months postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start30 Jan 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- Wan-Lin Pan, PHD, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237088
- Sponsor's protocol ID
- 111-E-21
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pan WL, Yang CC, Chen YH, Hsieh CH. Asynchronous online versus face-to-face mindfulness training for maternal mental health: A randomised controlled trial. Midwifery. 2026 Jul;158:104807. doi: 10.1016/j.midw.2026.104807. Epub 2026 Apr 2.
PubMed 41966722
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother-infant Connection Strategy Program: Impact on Psychological Distress and Mother-infant Bonding in Women
- ClinicalTrials.gov ID
- NCT06237088
- Acronym / sponsor ID
- 111-E-21
- Conditions
- Psychological, Mother-Infant Interaction
- Keywords
- Mindfulness, Anxiety, Depression, Mother-Infant Interaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the long-term effects of an online mindfulness-based program on the psychological distress and mother-infant bonding of women
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| eight-week mindfulness programs | Active comparator | Other: eight-week mindfulness programsThe intervention consists of 2.5-hour classes per week over a period of eight weeks. |
| online mindfulness program | Experimental | Other: online mindfulness programThe 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. |
| care as usual | No intervention | –Hospital-based antenatal care involves all aspects of pregnancy, childbirth and postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects were at the age over 18
- Could speak and read Chinese fluently
- Willing and be ale to attend the education program
Key exclusion criteria (2 listed)
- Taking medication for diagnosing mental illness
- With complicated or high-risk pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online mindfulness programThe 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 |
| eight-week mindfulness programsThe intervention consists of 2.5-hour classes per week over a period of eight weeks. | Other | eight-week mindfulness programs |
Primary outcome
anxiety
Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
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.
depression
Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
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
mindfulness
Time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
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"
mother-infant bonding
Time frame: the follow-up at 2 , 4 months postpartum.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 41966722Pan WL, Yang CC, Chen YH, Hsieh CH. Asynchronous online versus face-to-face mindfulness training for maternal mental health: A randomised controlled trial. Midwifery. 2026 Jul;158:104807. doi: 10.1016/j.midw.2026.104807. Epub 2026 Apr 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan-Lin Pan, PHD principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online mindfulness program and eight-week mindfulness programs in people with Psychological and Mother-Infant Interaction, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Lin Pan, PHD (886-2-28227101 ext. 3131, wanlimp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.