Skip to main content
Clinical Trials/NCT06557200
NCT06557200
Not Yet Recruiting
N/A

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

Universiti Putra Malaysia1 site in 1 country1,400 target enrollmentAugust 15, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postnatal Depression
Sponsor
Universiti Putra Malaysia
Enrollment
1400
Locations
1
Primary Endpoint
Post natal anxiety
Status
Not Yet Recruiting
Last Updated
last year

Overview

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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 15, 2024
End Date
August 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arshed Muhammad

PhD studentship

Universiti Putra Malaysia

Eligibility Criteria

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

Outcomes

Primary Outcomes

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).

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.

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 Sites (1)

Loading locations...

Similar Trials