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

ConditionsDepression Postpartum Pain Mental Health

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorKK Women's and Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Collaborative Psychological Model (CPM)
Other intervention
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.
Intervention common to both arms
Other intervention
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 intervention
Telephone-based support will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10.

Treatment groups

3,470 Participants

are divided into 2 treatment groups

Group A: Collaborative Psychological Model (CPM) groupExperimental treatment 2 interventions

Group B: Non- Collaborative Psychological Model (CPM) groupActive comparator 2 interventions

Trial outcomes

Primary outcomes

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.

Time frame