AnxietyB³NCT07483515
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
A study testing Group B (Intervention) in people with Anxiety and Pregnancy, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial summary
Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pregnancy, Parenting Self-efficacy
- What is being tested?
- Group B (Intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers:
- 21-50 years of age
- Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment
- Singleton pregnancy
- Nulliparous
- Plan to deliver in Singapore
Show all 17Show fewer
- Proficient and able to respond to questionnaires in English
- Intends for herself and her child to stay in Singapore for the next 2 years
- Access to a smartphone
- Willing to download the study app
- Score of 7 or more in the Edinburgh Postnatal Depression Scale
- Fathers:
- 21-75 years of age
- Proficient and able to respond to questionnaires in English
- Intends for himself and his child to stay in Singapore for the next 2 years
- Access to a smartphone
- Willing to download the study app
Who cannot join
- Mothers:
- Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders
- Currently on oral/IV steroids and/or thyroid medication
- History of thyroid disease
- Pregnant using assisted reproductive technologies
- Multiple pregnancies
Show all 10Show fewer
- Currently enrolled in interventional randomised controlled trials
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Institute for Human Development and Potential (IHDP), Singapore
Singapore, 117609
Santhi Ponmudi, MPh, +65-64070100, santhi_ponmudi@a-star.edu.sg
Michelle Z.L Kee, PhD
About this study
Official title: Bonding Before Birth: A Cluster-randomized, Controlled, mHealth Trial for Developing Mindfulness and Emotional Regulation in Expectant Couples
Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms.
This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.
Read more
Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.
Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.
Read the detailed description
The overall goal of this study is to answer the following main questions:
- Does the intervention improve parents' depressive symptoms scores, using the Edinburgh Postnatal Depression Scale as a proxy?
- Does the intervention improve parents' emotional regulation skills?
The study involves 286 expectant couples (572 individuals) in a two-arm, cluster-randomized controlled trial with longitudinal observational follow-up until the child turns 6 months old. The active intervention comprises of customized, weekly recommendations of short (2-5 minute) audio clips featuring activities such as breathing exercises, meditation, mindful walking. These will be provided to adult participants (expectant couples). Couples enrolling in the study will randomly be allocated to either the control or intervention group by prespecified block sizes of 10. That is, a random number generator will be used to preset the assignments in groups of 10, such that every 10 consecutive enrolments will have exactly 5 controls and 5 interventions (1:1 allocation). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm.
Participants in the control, no-intervention group will have access to a mobile app with similar functions as the participants in the intervention group, except that no personalized modules are given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
Participants in the intervention group will have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Participants will also be re-randomized weekly to different modules within the app. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
The intervention will take place throughout pregnancy, beginning at enrollment ( when the mother is less than 20 gestational weeks of pregnancy), and continuing until the child is born. As gestational duration varies among participants, the total intervention period will range approximately from 17 to 28 weeks, depending on the timing of recruitment and delivery. All study arms will be assessed up to 6 months after birth.
- Conditions
- Anxiety, Pregnancy, Parenting Self-efficacy, Stress (Psychology), Depression, Emotion Regulation
- Being tested
- Group B (Intervention)
- Keywords
- Reinforcement Learning, Micro-randomization, Emotion Regulation, Depression, Pregnancy, Anxiety
- Medical subject headings
- Anxiety Disorders, Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B (Intervention)Behavioural
Participants in the intervention group will receive recommended modules in the mHealth app installed on their phones.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Control) | No intervention | Participants' will have access to a mobile app with similar functions as the participants in the intervention group, except that there are no personalized modules given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
| Group B (Intervention) | Experimental | Participants have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. Receives: Behavioral: Group B (Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents' Depressive Symptoms
Parents' level of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale.
Measured: 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
Secondary outcomes (1)
Parents' emotional regulation skills
Examining self-reported parental emotional regulation skills using the Cognitive Emotion Regulation Questionnaire
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start6 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel, 2-arm, single-centre, cluster-randomized control trial. Eligible expectant couples will be randomized at baseline to either Group 1 (Intervention group) or Group 2 (Control group) based on 1:1 allocation ratio. Participants will received the assigned intervention from baseline until the birth of their child. All participants will be followed up until 6 months after the birth of their child. The mHealth app will be installed on the phones of subjects in both Groups, but only those in Group 1 (Intervention group) will have access ot the intervention components. Each couple in Group 1 will receive randomized intervention components (delivery of self, focus, relationship, or sleep-themed app modules).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, National University of Singapore
- Responsible party
- Principal investigator, Michelle Kee, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Michelle Z.L Kee, PhD, Principal investigator, Institute for Human Development and Potential
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483515
- Sponsor's protocol ID
- 2026-049
- Other IDs
- H22P0M0001, H22P0M0009, NUHSRO/2025/082/NUSMed/024/B3
- Acronym
- B³
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the availability of individual participant data for sharing requires further discussions between the institutes.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bonding Before Birth: A Cluster-randomized, Controlled, mHealth Trial for Developing Mindfulness and Emotional Regulation in Expectant Couples
- ClinicalTrials.gov ID
- NCT07483515
- Acronym / sponsor ID
- B³ / 2026-049
- Conditions
- Anxiety, Pregnancy, Parenting Self-efficacy, Stress (Psychology), Depression, Emotion Regulation
- Keywords
- Reinforcement Learning, Micro-randomization, Emotion Regulation, Depression, Pregnancy, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School, National University of Singapore
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Mar 2026 (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.
Emotional regulation is a key component of reducing parenting stress, a sense of self-efficacy, and thus successful parenting, child outcomes, and productivity amongst working parents. However, few interventions begin building these necessary components in pregnancy prior to the extremely stressful period immediately post-partum, where little trait and behavioural modification occurs. More importantly, most interventions overlook the importance of having both partners, despite fathers/partners playing a significant role in influencing maternal stress and mood symptoms.
This goal of this study is to examine whether short weekly exercises delivered through a mobile app can help first-time parents feel better emotionally during pregnancy. These exercises are designed to help people manage their emotions and stress. Researchers want to know if doing these exercises, along with getting weekly feedback and encouragement, can reduce signs of depression and improve emotional control.
Expecting mothers and fathers who are having their first child may be able to join the study if they meet certain conditions. Participants should be planning to stay in Singapore for the next two years and be comfortable using a smartphone and answering questions in English. Participants may benefit from learning new ways to manage stress and emotions, which could help improve their mental health.
Participants will wear a Fitbit watch to track activity. They will complete a short weekly survey about their well-being during pregnancy and a monthly survey about their work productivity until six months after the baby is born. They will also answer online surveys about their health, relationships, and background at the start, three times during pregnancy, and three times after birth. In addition, they will visit the research lab twice to take part in tasks that measure thinking and behaviour.
Detailed description
The overall goal of this study is to answer the following main questions:
- Does the intervention improve parents' depressive symptoms scores, using the Edinburgh Postnatal Depression Scale as a proxy?
- Does the intervention improve parents' emotional regulation skills?
The study involves 286 expectant couples (572 individuals) in a two-arm, cluster-randomized controlled trial with longitudinal observational follow-up until the child turns 6 months old. The active intervention comprises of customized, weekly recommendations of short (2-5 minute) audio clips featuring activities such as breathing exercises, meditation, mindful walking. These will be provided to adult participants (expectant couples). Couples enrolling in the study will randomly be allocated to either the control or intervention group by prespecified block sizes of 10. That is, a random number generator will be used to preset the assignments in groups of 10, such that every 10 consecutive enrolments will have exactly 5 controls and 5 interventions (1:1 allocation). While it is not possible to blind operational staff to assignments (different protocols to follow, highly unbalanced assignment), scheduling of enrolment visits will be done by different staff than those conducting the enrolment visits, and the assignment will only be made known to enrolment staff while conducting the visit itself and they will also not have access to the blocking and randomization algorithm.
Participants in the control, no-intervention group will have access to a mobile app with similar functions as the participants in the intervention group, except that no personalized modules are given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
Participants in the intervention group will have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Participants will also be re-randomized weekly to different modules within the app. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch.
The intervention will take place throughout pregnancy, beginning at enrollment ( when the mother is less than 20 gestational weeks of pregnancy), and continuing until the child is born. As gestational duration varies among participants, the total intervention period will range approximately from 17 to 28 weeks, depending on the timing of recruitment and delivery. All study arms will be assessed up to 6 months after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a parallel, 2-arm, single-centre, cluster-randomized control trial. Eligible expectant couples will be randomized at baseline to either Group 1 (Intervention group) or Group 2 (Control group) based on 1:1 allocation ratio. Participants will received the assigned intervention from baseline until the birth of their child. All participants will be followed up until 6 months after the birth of their child. The mHealth app will be installed on the phones of subjects in both Groups, but only those in Group 1 (Intervention group) will have access ot the intervention components. Each couple in Group 1 will receive randomized intervention components (delivery of self, focus, relationship, or sleep-themed app modules).
| Arm | Type | Receives |
|---|---|---|
| Group A (Control) | No intervention | –Participants' will have access to a mobile app with similar functions as the participants in the intervention group, except that there are no personalized modules given. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
| Group B (Intervention) | Experimental | Behavioral: Group B (Intervention)Participants have access to the mHealth app that will be installed on their mobile devices and have access to weekly personalized recommendations. Data will also be collected from online and in-app surveys, as well as via the Fitbit watch. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 21-50 years of age
- Less than 20 weeks of pregnancy, confirmed by ultrasonography upon enrolment
- Singleton pregnancy
- Nulliparous
- Plan to deliver in Singapore
Key exclusion criteria (10 listed)
- Any pre-existing or history of psychotic depression, schizophrenia, and bipolar disorders
- Currently on oral/IV steroids and/or thyroid medication
- History of thyroid disease
- Pregnant using assisted reproductive technologies
- Multiple 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 |
|---|---|---|
| Group B (Intervention)Participants in the intervention group will receive recommended modules in the mHealth app installed on their phones. | Behavioural | Group B (Intervention) |
Primary outcome
Parents' Depressive Symptoms
Time frame: 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
Parents' level of depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale.
1 secondary outcome
Parents' emotional regulation skills
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding the availability of individual participant data for sharing requires further discussions between the institutes.
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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.
Michelle Z.L Kee, PhD principal investigator
Institute for Human Development and Potential
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group B (Intervention) in people with Anxiety and Pregnancy, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
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 17 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santhi Ponmudi, MPh (+65-64070100, santhi_ponmudi@a-star.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents' Depressive Symptoms (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.