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Bonding Before Birth: An mHealth Intervention for first-time expectant couples

Bonding Before Birth: a cluster-randomized, controlled, mHealth trial for developing mindfulness and emotional regulation in expectant couples

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15166640
Enrollment
572
Registered
2025-10-29
Start date
2026-07-14
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of first-time parents' depressive symptoms, using Edinburgh Postnatal Depression Scale as a proxy Mental and Behavioural Disorders

Interventions

The proposed study will be a two-arm, cluster-randomized, controlled trial with longitudinal observational follow-up. The active intervention comprises of customized, weekly recommendations of short (

Sponsors

Institute for Human Development and Potential, A*STAR
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 75 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 13/03/2026: Mothers: 1. 21–50 years of age 2. Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment 3. Singleton pregnancy 4. Nulliparous 5. Plan to deliver in Singapore 6. Proficient and able to respond to questionnaires in English 7. Intends for herself and her child to stay in Singapore for the next 2 years 8. Access to a smartphone 9. Willing to download the study app 10. Score of 7 or more in the Edinburgh Postnatal Depression Scale Fathers: 1. 21–75 years of age 2. Proficient and able to respond to questionnaires in English 3. Intends for himself and his child to stay in Singapore for the next 2 years 4. Access to a smartphone 5. Willing to download the study app Previous inclusion criteria: Mothers: 1. 21–50 years of age 2. Less than 15 weeks of pregnancy, confirmed by ultrasonography upon enrolment 3. Singleton pregnancy 4. Nulliparous 5. Plan to deliver in Singapore 6. Proficient and able to respond to questionnaires in English 7. Intends for herself and her child to stay in Singapore for the next 2 years 8. Access to a smartphone 9. Willing to download the study app 10. Score of 7 or more in the Edinburgh Postnatal Depression Scale Fathers: 1. 21–75 years of age 2. Proficient and able to respond to questionnaires in English 3. Intends for himself and his child to stay in Singapore for the next 2 years 4. Access to a smartphone 5. Willing to download the study app

Exclusion criteria

Exclusion criteria: Mothers: 1. Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders 2. Currently on oral/IV steroids and/or thyroid medication 3. History of thyroid disease 4. Pregnant using assisted reproductive technologies 5. Multiple pregnancies 6. Currently enrolled in interventional randomised controlled trials 7. Responded "Yes, quite often" to EPDS item 10 ("The thought of harming myself has occurred to me") Fathers: 1. Currently enrolled in interventional randomised controlled trials

Design outcomes

Primary

MeasureTime frame
Current primary outcomes as of 13/03/2026: Parents' level of depressive symptoms measured using the Edinburgh Postnatal Depression Scale, administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. A composite outcome of the three postnatal EPDS measurements will be used as a primary outcome assessment. Previous primary outcomes: Parents' level of depressive symptoms measured using the Edinburgh Postnatal Depression Scale, administered upon enrollment, once at 16-20 gestation weeks, once at 24-28 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. A composite outcome of the three postnatal EPDS measurements will be used as a primary outcome assessment.

Secondary

MeasureTime frame
Current secondary outcomes as of 13/03/2026: Examining self-reported parental emotional regulation skills measured using the Cognitive Emotion Regulation Questionnaire, administered upon enrollment, once at 21-24 gestation weeks, once at 28-32 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months. Previous secondary outcomes: Examining self-reported parental emotional regulation skills measured using the Cognitive Emotion Regulation Questionnaire, administered upon enrollment, once at 16-20 gestation weeks, once at 24-28 weeks, once at 37-40 gestation weeks, and postnatal 1-, 3-, and 6-months.

Countries

Singapore

Contacts

Public ContactSanthi Ponmudi
b3_study@a-star.edu.sg+65-64070100

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026