Clinical trial NCT06557200: A Virtual Support Intervention for Postnatal Well-being
Official title: Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postnatal Depression
Mother-Infant Interaction
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: University of Lahore
First posted: 2024-08-16
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Post natal depression
timeFrame: Post natal Depression measured at baseline and 12 months
measure: Post natal anxiety
timeFrame: Post natal Anxiety measured at baseline and 12 months
measure: Intervention usage
timeFrame: Intervention usage measured at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ahmad Hospital
state: Punjab
Study officials:
References:
citation: Woody CA, Ferrari AJ, Siskind DJ, Whiteford HA, Harris MG. A systematic review and meta-regression of the prevalence and incidence of perinatal depression. J Affect Disord. 2017 Sep;219:86-92. doi: 10.1016/j.jad.2017.05.003. Epub 2017 May 8.
citation: Hahn-Holbrook J, Cornwell-Hinrichs T, Anaya I. Economic and Health Predictors of National Postpartum Depression Prevalence: A Systematic Review, Meta-analysis, and Meta-Regression of 291 Studies from 56 Countries. Front Psychiatry. 2018 Feb 1;8:248. doi: 10.3389/fpsyt.2017.00248. eCollection 2017.
citation: Coo S, Garcia MI, Mira A, Valdes V. The Role of Perinatal Anxiety and Depression in Breastfeeding Practices. Breastfeed Med. 2020 Aug;15(8):495-500. doi: 10.1089/bfm.2020.0091. Epub 2020 Jun 9.
citation: Rojas G. Análisis de La Situación de Uso de Servicios y Acceso a Tratamiento de La Depresión Posparto En Centros APS de La Región Metropolitana. Santiago, Chile: Universidad de Chile, http://www.crececontigo.gob.cl/wp-content/uploads/2015/11/5-Informe-Final-Analisis-de-lasituacion-de-uso-de-servicio-y-acceso-a-tratamiento-de-la-depresion-posparto.pdf (2013, accessed 15 January 2022).
citation: Priel A, Djalovski A, Zagoory-Sharon O, Feldman R. Maternal depression impacts child psychopathology across the first decade of life: Oxytocin and synchrony as markers of resilience. J Child Psychol Psychiatry. 2019 Jan;60(1):30-42. doi: 10.1111/jcpp.12880. Epub 2018 Feb 27.