CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III) (CODEPAD-III)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Pain; Mental Health; Postpartum
• Intervention / Treatment: Other: Collaborative Psychological Model (CPM); Other: Intervention common to both arms; Other: Telephone-based support (Control)

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 Type: Interventional
• Enrollment (Estimated): 3470
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ban Leong Sng, FFPMANZCA; Phone Number: 65-6394-1077; Email: sng.ban.leong@singhealth.com.sg
• Study Contact Backup: Name: Chin Wen Tan, PhD; Phone Number: 65-6394 8436; Email: Tan.Chin.Wen@kkh.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Mothers):

• 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.

Inclusion Criteria (Fathers):

• 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.

Exclusion Criteria (Mothers):

• History of intravenous drug or opioid abuse;
• Previous history of chronic pain syndrome.

Exclusion Criteria (Fathers):

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collaborative Psychological Model (CPM) group; 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.	Other: Collaborative Psychological Model (CPM); 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.; Other: Intervention common to both arms; 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.
Active Comparator: Non- Collaborative Psychological Model (CPM) group; 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.	Other: Intervention common to both arms; 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks after delivery (2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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".	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 postpartum.	8 weeks after delivery (2 months)

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Collaborators: National Medical Research Council (NMRC), Singapore
• Investigators: Principal Investigator: Ban Leong Sng, FFPMANZCA, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 12, 2026
• First Posted (Actual): August 19, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 12, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Personal Satisfaction; Pain; Depression; Psychological Well-Being
• Other Study ID Numbers: ECOS Ref 2026-1366; CSASI25jul-0004 (Other Grant/Funding Number: NMRC Clinician Scientist Award - Senior Investigator)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers in accordance with institutional policies regarding data governance, confidentiality, and the protection of research participants' information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No