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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ban Leong Sng, FFPMANZCA
- Telefonnummer: 65-6394-1077
- E-post: sng.ban.leong@singhealth.com.sg
Studera Kontakt Backup
- Namn: Chin Wen Tan, PhD
- Telefonnummer: 65-6394 8436
- E-post: Tan.Chin.Wen@kkh.com.sg
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The incidence of postnatal depression in both groups
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Amningsförmåga i båda grupperna
Tidsram: 8 veckor efter leverans (2 månader)
|
Amningsegenskapen kommer att bedömas med skala för amning, kort form (BSES-SF).
Amningsförmåga hänvisar till en mammas självförtroende och uppfattning om hur väl hon kan amma sitt spädbarn.
Den självadministrerade BSES-SF med 14 artiklar kommer i en 5-gradig Likert-skala där 1 indikerar inte alls säker och 5 indikerar alltid säker.
Poängen summeras för att ge ett intervall från 14 till 70, med högre poäng som indikerar högre nivåer av amningseffektivitet.
|
8 veckor efter leverans (2 månader)
|
|
Postpartum bindning i båda grupperna
Tidsram: 8 veckor efter leverans (2 månader)
|
Postpartum bonding kommer att bedömas av Postpartum Bonding Questionnaire (PBQ).
Den består av 25 poster i fyra underskalor: i) försämrad bindning; ii) avvisande och ilska; iii) oro för vården; och iv) risk för missbruk.
Objekten är baserade på Likert-skala från 0 (alltid) till 5 (aldrig), med en totalpoäng som sträcker sig från 0 till 125 där lägre PBQ-poäng är förknippade med bättre mamma-barnbindning.
|
8 veckor efter leverans (2 månader)
|
|
Hälsostatus i båda grupperna
Tidsram: 8 veckor efter leverans (2 månader)
|
Hälsostatus kommer att bedömas via EQ-5D-5L, ett standardiserat instrument för att mäta generiskt hälsotillstånd.
Den består av två komponenter; hälsotillståndsbeskrivning och utvärdering.
Hälsotillståndet mäts i termer av fem dimensioner (5D); rörlighet, egenvård, vanliga aktiviteter, smärta/obehag och ångest/depression; varje dimension varierar från 1-5 (5L).
Från dessa fem dimensioner beräknas EQ-5D-index med ett värde mellan 0-1.
Utvärderingsdelen omfattar en analog skala, som ber att markera hälsostatus på undersökningsdagen på en 20 cm vertikal skala med slutpunkterna 0 och 100.
Noll motsvarar "sämsta tänkbara hälsotillstånd" och hundra motsvarar "bästa tänkbara hälsotillstånd".
|
8 veckor efter leverans (2 månader)
|
|
The incidence of persistent postpartum pain (PPP) in both groups
Tidsram: 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)
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Ban Leong Sng, FFPMANZCA, KK Women's and Children's Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ECOS Ref 2026-1366
- CSASI25jul-0004 (Annat bidrag/finansieringsnummer: NMRC Clinician Scientist Award - Senior Investigator)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .