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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ban Leong Sng, FFPMANZCA
- Telefonnummer: 65-6394-1077
- E-Mail: sng.ban.leong@singhealth.com.sg
Studieren Sie die Kontaktsicherung
- Name: Chin Wen Tan, PhD
- Telefonnummer: 65-6394 8436
- E-Mail: Tan.Chin.Wen@kkh.com.sg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The incidence of postnatal depression in both groups
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Selbstwirksamkeit des Stillens in beiden Gruppen
Zeitfenster: 8 Wochen nach der Lieferung (2 Monate)
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Die Selbstwirksamkeit des Stillens wird anhand der Selbstwirksamkeitsskala des Stillens – Kurzform (BSES-SF) – bewertet.
Die Selbstwirksamkeit des Stillens bezieht sich auf das Selbstvertrauen und die Wahrnehmung einer Mutter, wie gut sie ihr Kind stillen kann.
Der 14 Punkte umfassende selbstverwaltete BSES-SF wird auf einer 5-Punkte-Likert-Skala geliefert, wobei 1 „überhaupt kein Selbstvertrauen“ und 5 „immer Selbstvertrauen“ bedeutet.
Die Werte werden summiert, um einen Bereich von 14 bis 70 zu ergeben, wobei höhere Werte auf ein höheres Maß an Selbstwirksamkeit beim Stillen hinweisen.
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8 Wochen nach der Lieferung (2 Monate)
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Postpartale Bindung in beiden Gruppen
Zeitfenster: 8 Wochen nach der Lieferung (2 Monate)
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Die postpartale Bindung wird anhand des Postpartum Bonding Questionnaire (PBQ) bewertet.
Es besteht aus 25 Items auf vier Unterskalen: i) beeinträchtigte Bindung; ii) Ablehnung und Wut; iii) Angst vor der Pflege; und iv) Missbrauchsrisiko.
Die Items basieren auf einer Likert-Skala von 0 (immer) bis 5 (nie) mit einer Gesamtpunktzahl von 0 bis 125, wobei niedrigere PBQ-Werte mit einer besseren Mutter-Kind-Bindung verbunden sind.
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8 Wochen nach der Lieferung (2 Monate)
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Gesundheitszustand in beiden Gruppen
Zeitfenster: 8 Wochen nach der Lieferung (2 Monate)
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Der Gesundheitszustand wird mittels EQ-5D-5L beurteilt, einem standardisierten Instrument zur Messung des allgemeinen Gesundheitszustands.
Es besteht aus zwei Komponenten; Beschreibung und Bewertung des Gesundheitszustandes.
Der Gesundheitszustand wird anhand von fünf Dimensionen (5D) gemessen; Mobilität, Selbstfürsorge, übliche Aktivitäten, Schmerzen/Unwohlsein und Angst/Depression; jede Dimension reicht von 1-5 (5L).
Aus diesen fünf Dimensionen wird der EQ-5D-Index berechnet, der einen Wert zwischen 0 und 1 hat.
Der Bewertungsteil umfasst eine analoge Skala, bei der der Gesundheitszustand am Tag der Befragung auf einer 20 cm langen vertikalen Skala mit den Endpunkten 0 und 100 markiert werden soll.
Null entspricht dem „schlechtesten vorstellbaren Gesundheitszustand“ und Hundert entspricht dem „besten vorstellbaren Gesundheitszustand“.
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8 Wochen nach der Lieferung (2 Monate)
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The incidence of persistent postpartum pain (PPP) in both groups
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ban Leong Sng, FFPMANZCA, KK Women's and Children's Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ECOS Ref 2026-1366
- CSASI25jul-0004 (Andere Zuschuss-/Finanzierungsnummer: NMRC Clinician Scientist Award - Senior Investigator)
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