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

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 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.

Conditions

• Depression
• Postpartum
• Pain
• Mental Health

Interventions

OTHER

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

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.

Sponsors & Collaborators

• National Medical Research Council (NMRC), Singapore

  collaborator OTHER_GOV

• KK Women's and Children's Hospital

  lead OTHER_GOV

Principal Investigators

• Ban Leong Sng, FFPMANZCA · KK Women's and Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2031-03-31

Completion

2031-12-31