PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be: Identifying and Targeting Cognitive Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum
研究概览
简要总结
The goal of this randomized controlled study is to evaluate whether an online intervention that combines psychoeducation and affective cognitive training can help prevent postpartum depression in pregnant women and co-parents who have been identified as having risk factors for postpartum depression through an online screening tool. A total of 520 expecting parents will be enrolled in the intervention trial.
Researchers will compare the online intervention to care as usual (CAU) in the Danish healthcare system to determine whether the intervention has a better preventive effect. The study also involves a low-risk comparison group (n = 5250) who will not receive the intervention but will complete the same assessments for background comparisons.
The main question is:
- Does the online intervention reduce the number of mothers who develop postpartum depression during the first six months after birth?
Other questions the study addresses include:
- How severe mothers' depressive symptoms are during the first six weeks postpartum, based on weekly online ratings?
- How do parents report their own stress levels and their infant's development six months after birth?
The study will also explore:
- How many co-parents develop postpartum depression during the first six months postpartum.
- Whether mothers experience additional benefit if their co-parent also completes the intervention.
Participants will:
- Complete a 4-5-week online intervention with 8-9 modules that include psychoeducation and cognitive-affective training.
- Complete online questionnaires and outcome assessments from home.
- Participate in a diagnostic interview by phone after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women in their second or third trimester, or co-parents.
- •Age ≥ 18 years.
- •Ability to speak and read Danish.
- •A cut-off score > 96 on a test of negative cognitive bias (scale 0-100), and/or a score > 23 on the Antenatal Risk Questionnaire (ANRQ).
- •Co-parents are categorized as at risk if their partner is identified as having risk factors.
排除标准
- •Current or past mental disorders within ICD-10 categories F00-F29 and F60-F
- •Current substance use.
- •EPDS score ≥ 11 for women or ≥ 10 for men, indicating clinically relevant depressive symptoms at baseline.
研究组 & 干预措施
Online prenatal affective cognitive training
Participants in this arm receive a 4-5-week online intervention consisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed independently on the online platform.
干预措施: Online prenatal affective cognitive training (Behavioral)
Care as usual (CAU)
Participants in this arm receive care-as-usual (CAU) provided within the Danish healthcare system. They do not receive access to the online intervention but complete the same assessments and follow-ups as the intervention group.
结局指标
主要结局
Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum
时间窗: 6 months postpartum
Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether participants meet criteria for postpartum depression.
次要结局
- Self-Reported Parental Stress at 6 Months Postpartum(6 months postpartum)
- Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum(Weekly assessments from birth to 6 weeks postpartum)
- Parent-Reported Infant Development at 6 Months Postpartum(6 months postpartum)
研究者
Kamilla Woznica Miskowiak
Professor
Mental Health Services in the Capital Region, Denmark