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Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth (CODEPAD-II)

Primary Purpose

Depression, Postpartum

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Integrated psychological program (IPP)
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Postpartum

Eligibility Criteria

21 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • healthy (American Society of Anesthesiologists physical status 2)
  • parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
  • with a singleton fetus;
  • to have delivery in this institution.

Exclusion Criteria:

  • current active psychiatric care;
  • history of intravenous drug or opioid abuse;
  • previous history of chronic pain syndrome.

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated psychological program (IPP) group

Non- Integrated psychological program (IPP) group

Arm Description

Patients are assigned to have mindfulness training and music listening before and after delivery. Video counselling will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.

Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.

Outcomes

Primary Outcome Measures

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 after delivery. 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.
The incidence of persistent postpartum pain (PPP) in both groups
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 after delivery.

Secondary Outcome Measures

Breastfeeding self-efficacy in both groups
The breastfeeding self-efficacy will be assessed by breastfeeding self-efficacy scale- short form (BSES-SF). Breastfeeding self-efficacy refers to a mother's confidence and perception of how well she can breastfeed her infant. The 14-item self-administered BSES-SF comes in a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. Scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Postpartum bonding in both groups
The postpartum bonding will be assessed by Postpartum Bonding Questionnaire (PBQ). It consists of 25 items on four sub scales: i) impaired bonding; ii) rejection and anger; iii) anxiety about care; and iv) risk of abuse. The items are based on Likert scale ranging from 0 (always) to 5 (never), with a total score ranging from 0 to 125 where lower PBQ scores are associated with better mother-child bonding.
Health status in both groups
Health status will be assessed via EQ-5D-5L, a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-5 (5L). From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the survey on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " worst imaginable health state", and hundred corresponds to "best imaginable health state".

Full Information

First Posted
March 9, 2022
Last Updated
August 8, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05285215
Brief Title
Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth
Acronym
CODEPAD-II
Official Title
Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD - II (Collaborative Outcomes of DEpression and Pain Associated With Delivery- II)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).
Detailed Description
The childbirth process is associated with the risk of developing postnatal depression (PND) and persistent postpartum pain (PPP), which could contribute to maternal morbidity. There is a lack of routine structured and effective programs in current practice to monitor and effectively manage PND and PPP. Pilot study found specific pain and psychological vulnerability factors associated with increased risk of PND after childbirth. The investigators propose an integrated psychological program (IPP) consisting of mindfulness mobile application, music listening, digital health video counselling and mobile electronic survey to effectively prevent, detect, monitor, and treat PND and PPP. The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth. The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale (EPDS) scores in a subgroup of laboring women (with outcomes of vaginal or emergency Cesarean delivery) that may have increased risk factors for PND. The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes (mother-child bonding, breastfeeding self-efficacy, quality of life). A total of 1480 women undergoing childbirth will be recruited in this randomized controlled trial. This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP. The IPP will also provide patient-centered care tailored to the individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated psychological program (IPP) group
Arm Type
Experimental
Arm Description
Patients are assigned to have mindfulness training and music listening before and after delivery. Video counselling will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.
Arm Title
Non- Integrated psychological program (IPP) group
Arm Type
No Intervention
Arm Description
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.
Intervention Type
Procedure
Intervention Name(s)
Integrated psychological program (IPP)
Intervention Description
Patients will listen to the music for 30 minutes before delivery, and resume music listening once they are comfortable after delivery. Upon discharge, they will be asked to have music listening at least 30 minutes per day until 8 weeks postnatal survey. Mindfulness training via mobile application is administered before delivery. After delivery, they are asked to perform mindfulness training for 10 minutes daily, until last follow-up at 8 weeks post-delivery. Mobile electronic survey will be used to assess patients' EPDS scores fortnightly, until the last follow-up at week 8 post-delivery. If the EPDS scoring is found to be equal to or more than 10, video counselling and/or face-to-face consultation will be arranged. Video counselling sessions will be offered if patients are found to have EPDS score of 10-12. For women found to have EPDS≥13, a face-to-face initial psychiatry consultation will be conducted.
Primary Outcome Measure Information:
Title
The incidence of postnatal depression in both groups
Description
Incidence of postnatal depression will be assessed via Edinburgh Postnatal Depression Scale (EPDS) score at week 8 after delivery. 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
8 weeks after delivery (2 months)
Title
The incidence of persistent postpartum pain (PPP) in both groups
Description
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 after delivery.
Time Frame
8 weeks after delivery (2 months)
Secondary Outcome Measure Information:
Title
Breastfeeding self-efficacy in both groups
Description
The breastfeeding self-efficacy will be assessed by breastfeeding self-efficacy scale- short form (BSES-SF). Breastfeeding self-efficacy refers to a mother's confidence and perception of how well she can breastfeed her infant. The 14-item self-administered BSES-SF comes in a 5-point Likert-type scale where 1 indicates not at all confident and 5 indicates always confident. Scores are summed to produce a range from 14 to 70, with higher scores indicating higher levels of breastfeeding self-efficacy.
Time Frame
8 weeks after delivery (2 months)
Title
Postpartum bonding in both groups
Description
The postpartum bonding will be assessed by Postpartum Bonding Questionnaire (PBQ). It consists of 25 items on four sub scales: i) impaired bonding; ii) rejection and anger; iii) anxiety about care; and iv) risk of abuse. The items are based on Likert scale ranging from 0 (always) to 5 (never), with a total score ranging from 0 to 125 where lower PBQ scores are associated with better mother-child bonding.
Time Frame
8 weeks after delivery (2 months)
Title
Health status in both groups
Description
Health status will be assessed via EQ-5D-5L, a standardized instrument for measuring generic health status. It is made up for two components; health state description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-5 (5L). From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves an analogue scale, asking to mark health status on the day of the survey on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " worst imaginable health state", and hundred corresponds to "best imaginable health state".
Time Frame
8 weeks after delivery (2 months)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only pregnant patients giving birth in the institution will be recruited.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: healthy (American Society of Anesthesiologists physical status 2) parturient women at term (36 weeks' gestation or more, nulliparous and multiparous); with a singleton fetus; to have delivery in this institution. Exclusion Criteria: current active psychiatric care; history of intravenous drug or opioid abuse; previous history of chronic pain syndrome.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Leong Sng
Phone
+65 6394 1077
Email
sng.ban.leong@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ban Leong Sng

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth

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