Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- Post natal anxiety
研究概览
简要总结
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
- maternal morbidity
- impaired parent-infant bonding
- long-term developmental challenges for the child.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, Care providers, and outcome assessors will be blinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Post natal anxiety
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Arshed Muhammad
PhD studentship
Universiti Putra Malaysia