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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ban Leong Sng, FFPMANZCA
- Telefoonnummer: 65-6394-1077
- E-mail: sng.ban.leong@singhealth.com.sg
Studie Contact Back-up
- Naam: Chin Wen Tan, PhD
- Telefoonnummer: 65-6394 8436
- E-mail: Tan.Chin.Wen@kkh.com.sg
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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Participants assigned to the interventional arm will receive the following psychological therapies:
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.
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Actieve vergelijker: 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.
|
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 will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The incidence of postnatal depression in both groups
Tijdsspanne: 8 weeks after delivery (2 months)
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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.
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8 weeks after delivery (2 months)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Borstvoeding self-efficacy in beide groepen
Tijdsspanne: 8 weken na bevalling (2 maanden)
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De self-efficacy van borstvoeding zal worden beoordeeld door middel van de borstvoeding self-efficacy scale-short form (BSES-SF).
Borstvoeding self-efficacy verwijst naar het vertrouwen en de perceptie van een moeder van hoe goed ze haar baby borstvoeding kan geven.
De 14-item zelf-toegediende BSES-SF wordt geleverd in een 5-punts Likert-type schaal waarbij 1 staat voor helemaal geen vertrouwen en 5 voor altijd vertrouwen.
Scores worden opgeteld om een bereik van 14 tot 70 te produceren, waarbij hogere scores wijzen op hogere niveaus van zelfredzaamheid bij het geven van borstvoeding.
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8 weken na bevalling (2 maanden)
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Postpartum hechting in beide groepen
Tijdsspanne: 8 weken na bevalling (2 maanden)
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De hechting na de bevalling wordt beoordeeld aan de hand van de Postpartum Bonding Questionnaire (PBQ).
Het bestaat uit 25 items op vier subschalen: i) verminderde hechting; ii) afwijzing en woede; iii) angst voor zorg; en iv) risico op misbruik.
De items zijn gebaseerd op een Likert-schaal van 0 (altijd) tot 5 (nooit), met een totaalscore van 0 tot 125, waarbij lagere PBQ-scores worden geassocieerd met een betere hechting tussen moeder en kind.
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8 weken na bevalling (2 maanden)
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Gezondheidstoestand in beide groepen
Tijdsspanne: 8 weken na bevalling (2 maanden)
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De gezondheidstoestand wordt beoordeeld via EQ-5D-5L, een gestandaardiseerd instrument voor het meten van de generieke gezondheidstoestand.
Het bestaat uit twee componenten; beschrijving en evaluatie van de gezondheidstoestand.
De gezondheidstoestand wordt gemeten aan de hand van vijf dimensies (5D); mobiliteit, zelfzorg, gebruikelijke activiteiten, pijn/ongemak en angst/depressie; elke afmeting variërend van 1-5 (5L).
Uit deze vijf dimensies wordt de EQ-5D-index berekend, met een waarde tussen 0-1.
Het evaluatiegedeelte omvat een analoge schaal, die vraagt om de gezondheidsstatus op de dag van de enquête aan te geven op een verticale schaal van 20 cm met eindpunten van 0 en 100.
Nul komt overeen met "slechtst denkbare gezondheidstoestand", en honderd komt overeen met "best denkbare gezondheidstoestand".
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8 weken na bevalling (2 maanden)
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The incidence of persistent postpartum pain (PPP) in both groups
Tijdsspanne: 8 weeks after delivery (2 months)
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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.
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8 weeks after delivery (2 months)
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Ban Leong Sng, FFPMANZCA, KK Women's and Children's Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ECOS Ref 2026-1366
- CSASI25jul-0004 (Ander subsidie-/financieringsnummer: NMRC Clinician Scientist Award - Senior Investigator)
Plan Individuele Deelnemersgegevens (IPD)
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