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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ban Leong Sng, FFPMANZCA
- Número de teléfono: 65-6394-1077
- Correo electrónico: sng.ban.leong@singhealth.com.sg
Copia de seguridad de contactos de estudio
- Nombre: Chin Wen Tan, PhD
- Número de teléfono: 65-6394 8436
- Correo electrónico: Tan.Chin.Wen@kkh.com.sg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The incidence of postnatal depression in both groups
Periodo de tiempo: 8 weeks after delivery (2 months)
|
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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Autoeficacia en lactancia materna en ambos grupos
Periodo de tiempo: 8 semanas después del parto (2 meses)
|
La autoeficacia de la lactancia materna se evaluará mediante la escala abreviada de autoeficacia de la lactancia materna (BSES-SF).
La autoeficacia para amamantar se refiere a la confianza y la percepción de una madre sobre qué tan bien puede amamantar a su bebé.
El BSES-SF autoadministrado de 14 ítems viene en una escala tipo Likert de 5 puntos donde 1 indica nada seguro y 5 indica siempre seguro.
Las puntuaciones se suman para producir un rango de 14 a 70, donde las puntuaciones más altas indican niveles más altos de autoeficacia en la lactancia.
|
8 semanas después del parto (2 meses)
|
|
Vínculo posparto en ambos grupos
Periodo de tiempo: 8 semanas después del parto (2 meses)
|
El vínculo posparto se evaluará mediante el Cuestionario de vínculo posparto (PBQ).
Consta de 25 ítems en cuatro subescalas: i) vinculación deteriorada; ii) rechazo e ira; iii) ansiedad por el cuidado; y iv) riesgo de abuso.
Los ítems se basan en una escala de Likert que va de 0 (siempre) a 5 (nunca), con una puntuación total que va de 0 a 125, donde las puntuaciones más bajas del PBQ se asocian con un mejor vínculo madre-hijo.
|
8 semanas después del parto (2 meses)
|
|
Estado de salud en ambos grupos
Periodo de tiempo: 8 semanas después del parto (2 meses)
|
El estado de salud se evaluará a través de EQ-5D-5L, un instrumento estandarizado para medir el estado de salud genérico.
Está compuesto por dos componentes; descripción y evaluación del estado de salud.
El estado de salud se mide en términos de cinco dimensiones (5D); movilidad, autocuidado, actividades habituales, dolor/malestar y ansiedad/depresión; cada dimensión que va desde 1-5 (5L).
A partir de estas cinco dimensiones se calcula el índice EQ-5D, que tiene un valor entre 0-1.
La parte de evaluación involucra una escala análoga, solicitando marcar el estado de salud el día de la encuesta en una escala vertical de 20 cm con puntos finales de 0 y 100.
Cero corresponde al "peor estado de salud imaginable", y cien corresponde al "mejor estado de salud imaginable".
|
8 semanas después del parto (2 meses)
|
|
The incidence of persistent postpartum pain (PPP) in both groups
Periodo de tiempo: 8 weeks after delivery (2 months)
|
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)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ban Leong Sng, FFPMANZCA, KK Women's and Children's Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ECOS Ref 2026-1366
- CSASI25jul-0004 (Otro número de subvención/financiamiento: NMRC Clinician Scientist Award - Senior Investigator)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .