A Virtual Support Intervention for Postnatal Well-being

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-08-10

Brief Summary

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

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Detailed Description

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Despite the prevalence and impact of PND and anxiety, access to timely and effective mental health care for postpartum women remains limited, particularly in resource-constrained settings.

Limited Research: There has been a historical underinvestment in mental health research in Pakistan, especially in maternal mental health.

Cultural Stigma: Mental health issues, particularly postpartum depression, are often stigmatized, leading to underreporting.

Data Infrastructure: Robust data collection and analysis systems for mental health are still developing in Pakistan The rationale for this study is grounded in the significant public health burden imposed by postnatal depression (PND) and anxiety, coupled with the limitations of traditional care models. Despite advancements in maternal and child health, postpartum mental health remains a neglected area in many countries, including Pakistan.

Conditions

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Postnatal Depression Mother-Infant Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants, Care providers, and outcome assessors will be blinded

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Digital Infant- parents support

Intervention Type BEHAVIORAL

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.

Control

No intervention will be provided except usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Infant- parents support

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes