DepressionCODEPAD-IIINCT07773259
CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)
A study testing Collaborative Psychological Model (CPM) and Intervention common to both arms in people with Depression and Postpartum, run by KK Women's and Children's Hospital.
Trial summary
The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Depression, Postpartum, Pain
- What is being tested?
- Collaborative Psychological Model (CPM) and Intervention common to both arms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,470 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2031
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy (American Society of Anesthesiologists (ASA) physical status II);
- Parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
- With a singleton fetus;
- Planning to have childbirth and delivery at study site;
- Patients with prior mental health history, and current active psychiatric care will also be recruited.
- Identified partner (e.g., husband or significant other) of the enrolled pregnant patient;
- Aged 21 years and above;
- Able to understand the study procedures and willing to participate in the 8 weeks postpartum assessment.
Who cannot join
- History of intravenous drug or opioid abuse;
- Previous history of chronic pain syndrome.
- Unable to provide informed consent (e.g., cognitive impairment, language barriers without available translation support);
- Any condition that, in the opinion of the investigators, would make participation inappropriate (e.g., severe psychiatric or medical condition).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Collaborative Psychological Model for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)
The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after childbirth.
The study site proposes a Collaborative Psychological Model (CPM) consisting of music listening, customized mobile application on psychological strategies, telephone-based support, with monitoring (mobile electronic surveys, wearable-based vital sign monitoring) to effectively prevent, detect, monitor, and treat depression and persistent pain after childbirth. The study will determine if using the CPM will reduce the risk of having depression associated with childbirth. The study will also find out whether the CPM will reduce the depressive symptoms in women who undergo labor that may have increased depression risk. This clinical study will involve 2042 women undergoing childbirth at KK Hospital. In addition, up to 1428 patients' partners (fathers) will also be recruited for the week 8 postpartum assessment.
The study findings will improve healthcare for women in the community by incorporating digital psychological strategies to manage depression and persistent pain after childbirth. The CPM will also guide future directions to customize an individual's healthcare needs and to improve transition from hospital to community care for women after childbirth.
Read the detailed description
Postnatal depression (PND) represents a substantial burden, contributing to adverse outcomes for mothers, their infants, and families. The global incidence of PND has been reported to be about 17%, with Southeast Asia countries having a pooled incidence of 22%. Established risk factors include the severity of pain experienced during childbirth, analgesic techniques employed, and underlying psychological vulnerabilities.
Cesarean delivery, especially emergency Cesarean delivery, has been associated with an increased risk of PND. Childbirth often results in substantial tissue trauma, which may lead to persistent postpartum pain (PPP) that affects up to 20% of women globally. Both PND and PPP could contribute to a significant socioeconomic burden and diminished quality of life. Non-pharmacological interventions have demonstrated effectiveness in reducing depression and pain in postpartum women, as well as in populations with depression, and chronic pain. However, it remains uncertain whether delivering these interventions as part of a structured Collaborative Psychological Model (CPM) can effectively reduce the incidence of both PND and PPP. Currently, there is a lack of standardized and effective programs, with high risk PND stratification, addressing these outcomes in routine clinical care.
The proposed CPM in this study addresses these gaps through electronic surveys and mobile apps that enable mothers to manage their mental health without reliance on pharmacological therapy in a comfortable and private manner. By integrating multiple evidence-based interventions into a single program, we aim to leverage upon their individual efficacies and achieve a synergistic effect to improve outcomes related to PND and PPP.
- Conditions
- Depression, Postpartum, Pain, Mental Health
- Being tested
- Collaborative Psychological Model (CPM), Intervention common to both arms, Telephone-based support (Control)
- Medical subject headings
- Depression, Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Psychological Model (CPM)Other
Participants assigned to the interventional arm will receive the following psychological therapies:
- Participants will be provided with a 2-month Spotify subscription for music listening for at least 30 minutes daily until week 8 postpartum follow-up survey. Data on the duration of music listening, preferred genres, and patient satisfaction will be collected at week 8 postpartum.
- A customized mobile app incorporating artificial-intelligence-powered chatbot for personalized support, in-app guidance on mindfulness exercises, coping strategies with pain and mood, and educational resources will be provided to patients for use from after delivery till week 8 postpartum.
- Telephone-based support session by a team of assigned research coordinators will be offered for all patients with high risk of postnatal depression; or patients with low risk of postnatal depression and having Edinburgh Postnatal Depression Scale (EPDS) ≥ 10, throughout the fortnightly EPDS monitoring.
Intervention common to both armsOther
Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum.
Telephone-based support (Control)Other
Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Psychological Model (CPM) group | Experimental | Patients are assigned to have mindfulness training through customised mobile app on psychological strategies, and music listening before discharge from hospital until week 8 postpartum. Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10 (low risk of postnatal depression), or all patients of high risk of postnatal depression. Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum. Receives: Other: Collaborative Psychological Model (CPM); Other: Intervention common to both arms |
| Non- Collaborative Psychological Model (CPM) group | Active comparator | Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum. Receives: Other: Intervention common to both arms; Other: Telephone-based support (Control) |
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 postpartum. 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)
Secondary outcomes (4)
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 postpartum.
Measured: 8 weeks after delivery (2 months)
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 posted19 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Ban Leong Sng, FFPMANZCA, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773259
- Sponsor's protocol ID
- ECOS Ref 2026-1366
- Other IDs
- CSASI25jul-0004
- Acronym
- CODEPAD-III
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers in accordance with institutional policies regarding data governance, confidentiality, and the protection of research participants' information.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Psychological Model for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)
- ClinicalTrials.gov ID
- NCT07773259
- Acronym / sponsor ID
- CODEPAD-III / ECOS Ref 2026-1366
- Conditions
- Depression, Postpartum, Pain, Mental Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,470 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 19 Aug 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.
The childbirth process is associated with increased risk of having depression and persistent pain which may have adverse effects to mothers and their babies. There is a lack of routine effective programs in current healthcare practice to address, risk stratify and reduce depression and persistent pain after childbirth.
The study site proposes a Collaborative Psychological Model (CPM) consisting of music listening, customized mobile application on psychological strategies, telephone-based support, with monitoring (mobile electronic surveys, wearable-based vital sign monitoring) to effectively prevent, detect, monitor, and treat depression and persistent pain after childbirth. The study will determine if using the CPM will reduce the risk of having depression associated with childbirth. The study will also find out whether the CPM will reduce the depressive symptoms in women who undergo labor that may have increased depression risk. This clinical study will involve 2042 women undergoing childbirth at KK Hospital. In addition, up to 1428 patients' partners (fathers) will also be recruited for the week 8 postpartum assessment.
The study findings will improve healthcare for women in the community by incorporating digital psychological strategies to manage depression and persistent pain after childbirth. The CPM will also guide future directions to customize an individual's healthcare needs and to improve transition from hospital to community care for women after childbirth.
Detailed description
Postnatal depression (PND) represents a substantial burden, contributing to adverse outcomes for mothers, their infants, and families. The global incidence of PND has been reported to be about 17%, with Southeast Asia countries having a pooled incidence of 22%. Established risk factors include the severity of pain experienced during childbirth, analgesic techniques employed, and underlying psychological vulnerabilities.
Cesarean delivery, especially emergency Cesarean delivery, has been associated with an increased risk of PND. Childbirth often results in substantial tissue trauma, which may lead to persistent postpartum pain (PPP) that affects up to 20% of women globally. Both PND and PPP could contribute to a significant socioeconomic burden and diminished quality of life. Non-pharmacological interventions have demonstrated effectiveness in reducing depression and pain in postpartum women, as well as in populations with depression, and chronic pain. However, it remains uncertain whether delivering these interventions as part of a structured Collaborative Psychological Model (CPM) can effectively reduce the incidence of both PND and PPP. Currently, there is a lack of standardized and effective programs, with high risk PND stratification, addressing these outcomes in routine clinical care.
The proposed CPM in this study addresses these gaps through electronic surveys and mobile apps that enable mothers to manage their mental health without reliance on pharmacological therapy in a comfortable and private manner. By integrating multiple evidence-based interventions into a single program, we aim to leverage upon their individual efficacies and achieve a synergistic effect to improve outcomes related to PND and PPP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Psychological Model (CPM) group | Experimental | Other: Collaborative Psychological Model (CPM), Other: Intervention common to both armsPatients are assigned to have mindfulness training through customised mobile app on psychological strategies, and music listening before discharge from hospital until week 8 postpartum. Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10 (low risk of postnatal depression), or all patients of high risk of postnatal depression. Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum. |
| Non- Collaborative Psychological Model (CPM) group | Active comparator | Other: Intervention common to both arms, Other: Telephone-based support (Control)Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Patients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy (American Society of Anesthesiologists (ASA) physical status II);
- Parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
- With a singleton fetus;
- Planning to have childbirth and delivery at study site;
- Patients with prior mental health history, and current active psychiatric care will also be recruited.
Key exclusion criteria (4 listed)
- History of intravenous drug or opioid abuse;
- Previous history of chronic pain syndrome.
- Unable to provide informed consent (e.g., cognitive impairment, language barriers without available translation support);
- Any condition that, in the opinion of the investigators, would make participation inappropriate (e.g., severe psychiatric or medical condition).
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 |
|---|---|---|
| Collaborative Psychological Model (CPM)Participants assigned to the interventional arm will receive the following psychological therapies: 1. Participants will be provided with a 2-month Spotify subscription for music listening for at least 30 minutes daily until week 8 postpartum follow-up survey. Data on the duration of music listening, preferred genres, and patient satisfaction will be collected at week 8 postpartum. 2. A customized mobile app incorporating artificial-intelligence-powered chatbot for personalized support, in-app guidance on mindfulness exercises, coping strategies with pain and mood, and educational resources will be provided to patients for use from after delivery till week 8 postpartum. 3. Telephone-based support session by a team of assigned research coordinators will be offered for all patients with high risk of postnatal depression; or patients with low risk of postnatal depression and having Edinburgh Postnatal Depression Scale (EPDS) ≥ 10, throughout the fortnightly EPDS monitoring. | Other | Collaborative Psychological Model (CPM) group |
| Intervention common to both armsPatients will receive a wearable device to monitor heart rate variability, sleep patterns, activity metrics (steps, distance, calories) from delivery until week 8 postpartum. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being week 8 postpartum. | Other | Collaborative Psychological Model (CPM) group, Non- Collaborative Psychological Model (CPM) group |
| Telephone-based support (Control)Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. | Other | Non- Collaborative Psychological Model (CPM) 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 postpartum. 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.
4 secondary outcomes
The incidence of persistent postpartum pain (PPP) in both groups
Time frame: 8 weeks after delivery (2 months)
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
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 19 Aug 2026.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers in accordance with institutional policies regarding data governance, confidentiality, and the protection of research participants' information.
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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.
Ban Leong Sng, FFPMANZCA principal investigator
KK Women's and Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Psychological Model (CPM) and Intervention common to both arms in people with Depression and Postpartum, run by KK Women's and Children's Hospital.
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ban Leong Sng, FFPMANZCA (65-6394-1077, sng.ban.leong@singhealth.com.sg), or a site near the patient. 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)). 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 19 Aug 2026.