A Virtual Support Intervention for Postnatal Well-being
- Conditions
- Mother-Infant InteractionPostnatal Depression
- Interventions
- Behavioral: Digital Infant- parents support
- Registration Number
- NCT06557200
- Lead Sponsor
- Universiti Putra Malaysia
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1400
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group 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.
- Primary Outcome Measures
Name Time Method Post natal anxiety 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ahmad Hospital
🇵🇰Lahore, Punjab, Pakistan