A Virtual Support Intervention for Postnatal Well-being

University of Putra Malaysia (UPM)

Status: Not yet enrolling

Conditions: Mother-Infant Interaction; Postnatal Depression

Treatments: Behavioral: Digital Infant- parents support

Study type: Interventional

Funder types: Other

Identifiers

NCT06557200

UIPT

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,400 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Digital Infant- parents support

Control

No Intervention group

Description:

No intervention will be provided except usual care