NCT06557200

Brief Summary

Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of

  1. 1.maternal morbidity
  2. 2.impaired parent-infant bonding
  3. 3.long-term developmental challenges for the child.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 13, 2024

Last Update Submit

August 13, 2024

Conditions

Postnatal DepressionMother-Infant Interaction

Outcome Measures

Primary Outcomes (3)

  • Post natal depression

    Edinburgh Postnatal Depression Scale (EPDS): A standardized self-report questionnaire to assess symptoms of postnatal depression. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Scores of 13 indicate an 80% chance that the mother has depression.

    Post natal Depression measured at baseline and 12 months

  • Post natal anxiety

    Generalized Anxiety Disorder-7 (GAD-7): A self-report measure to assess symptoms of generalized anxiety disorder. The GAD-7 scores were also represented with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).

    Post natal Anxiety measured at baseline and 12 months

  • Intervention usage

    Intervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform.

    Intervention usage measured at 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.

Behavioral: Digital Infant- parents support

Control

NO INTERVENTION

No intervention will be provided except usual care

Interventions

Digital Infant- parents supportBEHAVIORAL

A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pakistani female aged 18-45 years
  • Recent childbirth (within 0-6 weeks)
  • Access to a smartphone or computer with internet connectivity
  • Able to understand and communicate in Urdu or English
  • Willing to provide informed consent

You may not qualify if:

  • Pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder)
  • Current substance abuse or dependence
  • Limited or no access to the internet or smartphone
  • Inability to understand or communicate in Urdu or English
  • Pregnancy complications requiring intensive care
  • Infants with severe medical conditions requiring hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad Hospital

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (5)

  • Woody CA, Ferrari AJ, Siskind DJ, Whiteford HA, Harris MG. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. J Affect Disord. 2017 Sep;219:86-92. doi: 10.1016/j.jad.2017.05.003. Epub 2017 May 8.

    PMID: 28531848BACKGROUND

  • Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.

    PMID: 29449816BACKGROUND

  • Coo S, Garcia MI, Mira A, Valdes V. The Role of Perinatal Anxiety and Depression in Breastfeeding Practices. Breastfeed Med. 2020 Aug;15(8):495-500. doi: 10.1089/bfm.2020.0091. Epub 2020 Jun 9.

    PMID: 32522015BACKGROUND

  • Rojas G. Análisis de La Situación de Uso de Servicios y Acceso a Tratamiento de La Depresión Posparto En Centros APS de La Región Metropolitana. Santiago, Chile: Universidad de Chile, http://www.crececontigo.gob.cl/wp-content/uploads/2015/11/5-Informe-Final-Analisis-de-lasituacion-de-uso-de-servicio-y-acceso-a-tratamiento-de-la-depresion-posparto.pdf (2013, accessed 15 January 2022).

    BACKGROUND

  • Priel A, Djalovski A, Zagoory-Sharon O, Feldman R. Maternal depression impacts child psychopathology across the first decade of life: Oxytocin and synchrony as markers of resilience. J Child Psychol Psychiatry. 2019 Jan;60(1):30-42. doi: 10.1111/jcpp.12880. Epub 2018 Feb 27.

    PMID: 29484656BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Raashed Muhammad, Master

CONTACT

03249479263stunning003@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, Care providers, and outcome assessors will be blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD studentship

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 16, 2024

Study Start

August 15, 2024

Primary Completion

July 15, 2025

Study Completion

August 10, 2025

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Study protocol, Statistical plan, Results will be desseminated through publications

Locations

PA(1)