Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
研究概览
简要总结
Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.
The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression. In the study, 226 pregnant women, some of whom are considered high risk due to past mental illness or psycho-social risk factors, will participate. The high-risk women will be divided into two groups. One group will undergo the PACT training, which involves computer and virtual reality exercises spanning five weeks, designed to improve mood and emotional regulation. The other group will receive usual care. The study also involves a low-risk group (n=146), although these individuals are not part of the intervention trial but are merely followed up with the same assessments for background comparisons.The main aim is to observe whether the women who undergo PACT intervention are less prone to depression after childbirth compared to those who do not.
This study has potential to offer a simple, non-invasive method to bolster mental health in expectant mothers, which could also positively impact their infants.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for General Pregnant Population:
- •Second or third trimester pregnancy.
- •Age ≥ 18 years.
- •Ability to speak and read Danish.
- •Inclusion Criteria for High-Risk Pregnant Group:
- •Negative cognitive bias in emotional reactivity to infant distress (cut-off > 96 on a scale from 0-100).
- •High-risk status according to the Antenatal Risk Questionnaire (ANRQ) which means:
- •Personal history of severe mental illness.
- •Experienced childhood emotional, physical, or sexual abuse.
- •Total score on psycho-social risk factors is above the cut-off (> 23).
- •Inclusion Criteria for Low-Risk Pregnant Group:
- •Absence of a personal or family history of mental illness.
- •Absence of negative bias.
- •Three or fewer of the additional risk factors mentioned above.
排除标准
- •Schizophrenia.
- •Current substance use disorder.
- •Score of 9 or more on the Hamilton Depression Rating Scale-6 items (HDRS-6), indicating moderate depression.
- •Pregnant women diagnosed with a personality disorder (note: they will still be included at baseline and follow-up after birth but will be excluded from randomization).
结局指标
主要结局
The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
时间窗: Six months after birth
The primary outcome is the difference between mothers receiving PACT versus CAU in the incidence of PPD during the first six months after birth, assessed by a clinician blind to group status with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
次要结局
- Change in negative cognitive bias(In third trimester of pregnancy)
- Self-rated depressive symptoms(Within six weeks after birth)
- Self-rated parental stress(Six months after birth)