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NCT Number: NCT06557200

A Virtual Support Intervention for Postnatal Well-being

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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Key information

Conditions

Postnatal Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Mother-Infant Interaction Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Infant- parents support

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.

Primary outcomes

  1. Post natal depression

    Time frame: Post natal Depression measured at baseline and 12 months

    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.

  2. Post natal anxiety

    Time frame: Post natal Anxiety measured at baseline and 12 months

    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).

  3. Intervention usage

    Time frame: Intervention usage measured at 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Raashed Muhammad, Master

CONTACT

[email protected]

03249479263

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • University of Lahore

Registry information

Official study title

Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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