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

2026年8月12日 更新者：Sng Ban Leong、KK Women's and Children's Hospital

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

3470

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：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.
其他：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.
有源比较器：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.
其他：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.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The incidence of postnatal depression in both groups
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
两组的母乳喂养自我效能
大体时间：产后8周（2个月）
母乳喂养自我效能将通过母乳喂养自我效能量表简表（BSES-SF）进行评估。 母乳喂养自我效能是指母亲对自己母乳喂养婴儿的信心和看法。 14 项自我管理的 BSES-SF 采用 5 点李克特式量表，其中 1 表示完全没有信心，5 表示始终有信心。 分数相加产生 14 到 70 的范围，分数越高表明母乳喂养的自我效能水平越高。
产后8周（2个月）
两组产后结合
大体时间：产后8周（2个月）
产后结合将通过产后结合问卷 (PBQ) 进行评估。 它由四个子量表的 25 个项目组成：i) 受损的结合； ii) 拒绝和愤怒； iii) 对护理的焦虑； iv) 滥用风险。 这些项目基于 Likert 量表，从 0（总是）到 5（从不），总分从 0 到 125，其中较低的 PBQ 分数与更好的母子关系相关。
产后8周（2个月）
两组健康状况
大体时间：产后8周（2个月）
健康状况将通过 EQ-5D-5L 进行评估，EQ-5D-5L 是一种用于测量一般健康状况的标准化仪器。 它由两个部分组成；健康状况描述和评价。 健康状况从五个维度（5D）来衡量；行动不便、自理、日常活动、疼痛/不适和焦虑/抑郁；每个维度从1-5（5L）不等。 从这五个维度计算出 EQ-5D 指数，其值介于 0-1 之间。 评价部分涉及模拟量表，要求在20厘米的垂直刻度上标注调查当天的健康状况，终点为0和100。 零对应“可想象的最差健康状态”，百对应“可想象的最佳健康状态”。
产后8周（2个月）
The incidence of persistent postpartum pain (PPP) in both groups
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

KK Women's and Children's Hospital

合作者

National Medical Research Council (NMRC), Singapore

调查人员

  • 首席研究员：Ban Leong Sng, FFPMANZCA、KK Women's and Children's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2031年3月1日

研究完成 (估计的)

2031年12月1日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ECOS Ref 2026-1366
  • CSASI25jul-0004 (其他赠款/资助编号：NMRC Clinician Scientist Award - Senior Investigator)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

IPD will not be shared with other researchers in accordance with institutional policies regarding data governance, confidentiality, and the protection of research participants' information.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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