Depression, PostpartumCODEPAD-IINCT05285215
Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth
A study testing Integrated psychological program (IPP) in people with Depression, Postpartum, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Integrated psychological program (IPP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,716 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Apr 2022to 1 Dec 2025
- 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 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- healthy (American Society of Anesthesiologists physical status 2)
- parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
- with a singleton fetus;
- to have delivery in this institution.
Who cannot join
- current active psychiatric care;
- history of intravenous drug or opioid abuse;
- previous history of chronic pain syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD - II (Collaborative Outcomes of DEpression and Pain Associated With Delivery- II)
The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).
Read the detailed description
The childbirth process is associated with the risk of developing postnatal depression (PND) and persistent postpartum pain (PPP), which could contribute to maternal morbidity. There is a lack of routine structured and effective programs in current practice to monitor and effectively manage PND and PPP. Pilot study found specific pain and psychological vulnerability factors associated with increased risk of PND after childbirth.
The investigators propose an integrated psychological program (IPP) consisting of mindfulness mobile application, music listening, digital health video counselling and mobile electronic survey to effectively prevent, detect, monitor, and treat PND and PPP. The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth. The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale (EPDS) scores in a subgroup of laboring women (with outcomes of vaginal or emergency Cesarean delivery) that may have increased risk factors for PND. The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes (mother-child bonding, breastfeeding self-efficacy, quality of life). A total of 1716 women undergoing childbirth will be recruited in this randomized controlled trial.
This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP. The IPP will also provide patient-centered care tailored to the individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.
- Conditions
- Depression, Postpartum
- Being tested
- Integrated psychological program (IPP)
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated psychological program (IPP)Procedure or surgery
Patients will listen to the music once they are comfortable after delivery before discharge from hospital. Upon discharge, they will be asked to have music listening at least 30 minutes per day until 2 months postnatal survey.
Mindfulness training via mobile application is administered before discharge from hospital. Upon discharge, they are asked to perform mindfulness training for 10 minutes daily, until last follow-up at 2 months post-delivery.
Mobile electronic survey will be used to assess patients' EPDS scores fortnightly, until the last follow-up at 2 months post-delivery. If the EPDS scoring is found to be equal to or more than 10, video counselling and/or face-to-face consultation will be arranged.
Video counselling sessions will be offered if patients are found to have EPDS score of 10-12. For women found to have EPDS≥13, a face-to-face initial psychiatry consultation will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Integrated psychological program (IPP) group | Experimental | Patients are assigned to have mindfulness training and music listening before discharge from hospital until 2 months after delivery. Video counselling will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery. Receives: Procedure: Integrated psychological program (IPP) |
| Non- Integrated psychological program (IPP) group | No intervention | Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postnatal depression in both groups
Incidence of postnatal depression will be assessed via Edinburgh Postnatal Depression Scale (EPDS) score at week 8 after delivery. EPDS is a 10-item self reporting scale to evaluate the postnatal depression. Participants are asked to respond according to how they have felt in the past seven days. Each item is measured on a 4-point scale (0-3), with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 10 and above indicates clinically significant depressive symptoms.
Measured: 8 weeks after delivery (2 months)
The incidence of persistent postpartum pain (PPP) in both groups
The incidence of PPP is defined as the presence of pain for 8 weeks at the perineal, surgical scar or abdominal region related to childbirth at week 8 after delivery.
Measured: 8 weeks after delivery (2 months)
Secondary outcomes (3)
Breastfeeding self-efficacy in both groups
The breastfeeding self-efficacy will be assessed by breastfeeding self-efficacy scale- short form (BSES-SF). Breastfeeding self-efficacy refers to a mother's confidence and perception of how well she can breastfeed her infant. The 14-item self-administered BSES-SF comes in a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. Scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Measured: 8 weeks after delivery (2 months)
Postpartum bonding in both groups
The postpartum bonding will be assessed by Postpartum Bonding Questionnaire (PBQ). It consists of 25 items on four sub scales: i) impaired bonding; ii) rejection and anger; iii) anxiety about care; and iv) risk of abuse. The items are based on Likert scale ranging from 0 (always) to 5 (never), with a total score ranging from 0 to 125 where lower PBQ scores are associated with better mother-child bonding.
Measured: 8 weeks after delivery (2 months)
Health status in both groups
Health status will be assessed via EQ-5D-5L, a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-5 (5L). From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the survey on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " worst imaginable health state", and hundred corresponds to "best imaginable health state".
Measured: 8 weeks after delivery (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start18 Apr 2022
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- None (open label)
- Enrolment
- 1,716 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285215
- Sponsor's protocol ID
- CSAINV21jun-0008
- Acronym
- CODEPAD-II
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD - II (Collaborative Outcomes of DEpression and Pain Associated With Delivery- II)
- ClinicalTrials.gov ID
- NCT05285215
- Acronym / sponsor ID
- CODEPAD-II / CSAINV21jun-0008
- Conditions
- Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,716 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Mar 2022 (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.
The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).
Detailed description
The childbirth process is associated with the risk of developing postnatal depression (PND) and persistent postpartum pain (PPP), which could contribute to maternal morbidity. There is a lack of routine structured and effective programs in current practice to monitor and effectively manage PND and PPP. Pilot study found specific pain and psychological vulnerability factors associated with increased risk of PND after childbirth.
The investigators propose an integrated psychological program (IPP) consisting of mindfulness mobile application, music listening, digital health video counselling and mobile electronic survey to effectively prevent, detect, monitor, and treat PND and PPP. The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth. The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale (EPDS) scores in a subgroup of laboring women (with outcomes of vaginal or emergency Cesarean delivery) that may have increased risk factors for PND. The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes (mother-child bonding, breastfeeding self-efficacy, quality of life). A total of 1716 women undergoing childbirth will be recruited in this randomized controlled trial.
This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP. The IPP will also provide patient-centered care tailored to the individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated psychological program (IPP) group | Experimental | Procedure: Integrated psychological program (IPP)Patients are assigned to have mindfulness training and music listening before discharge from hospital until 2 months after delivery. Video counselling will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery. |
| Non- Integrated psychological program (IPP) group | No intervention | –Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy (American Society of Anesthesiologists physical status 2)
- parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
- with a singleton fetus;
- to have delivery in this institution.
Key exclusion criteria (3 listed)
- current active psychiatric care;
- history of intravenous drug or opioid abuse;
- previous history of chronic pain syndrome.
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 |
|---|---|---|
| Integrated psychological program (IPP)Patients will listen to the music once they are comfortable after delivery before discharge from hospital. Upon discharge, they will be asked to have music listening at least 30 minutes per day until 2 months postnatal survey. Mindfulness training via mobile application is administered before discharge from hospital. Upon discharge, they are asked to perform mindfulness training for 10 minutes daily, until last follow-up at 2 months post-delivery. Mobile electronic survey will be used to assess patients' EPDS scores fortnightly, until the last follow-up at 2 months post-delivery. If the EPDS scoring is found to be equal to or more than 10, video counselling and/or face-to-face consultation will be arranged. Video counselling sessions will be offered if patients are found to have EPDS score of 10-12. For women found to have EPDS≥13, a face-to-face initial psychiatry consultation will be conducted. | Procedure or surgery | Integrated psychological program (IPP) group |
Primary outcome
The incidence of postnatal depression in both groups
Time frame: 8 weeks after delivery (2 months)
Incidence of postnatal depression will be assessed via Edinburgh Postnatal Depression Scale (EPDS) score at week 8 after delivery. EPDS is a 10-item self reporting scale to evaluate the postnatal depression. Participants are asked to respond according to how they have felt in the past seven days. Each item is measured on a 4-point scale (0-3), with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 10 and above indicates clinically significant depressive symptoms.
The incidence of persistent postpartum pain (PPP) in both groups
Time frame: 8 weeks after delivery (2 months)
The incidence of PPP is defined as the presence of pain for 8 weeks at the perineal, surgical scar or abdominal region related to childbirth at week 8 after delivery.
3 secondary outcomes
Breastfeeding self-efficacy in both groups
Time frame: 8 weeks after delivery (2 months)
Postpartum bonding in both groups
Time frame: 8 weeks after delivery (2 months)
Health status in both groups
Time frame: 8 weeks after delivery (2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Ban Leong Sng principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated psychological program (IPP) in people with Depression, Postpartum, run by KK Women's and Children's Hospital 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postnatal depression in both groups (time frame: 8 weeks after delivery (2 months)). The study lists 2 primary outcomes in all. 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 7 Aug 2026.