Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Reduced generalized anxiety disorder
研究概览
简要总结
Anxiety is one of the most frequent disorders during the perinatal stage which is associated with adverse health effects for women and their babies. In spite of this, preventive interventions during this stage are scarce. The National Institute for Health and Clinical Excellence recommends psychological interventions, such as cognitive behavioral therapy, as a first-line treatment for mild and moderate prenatal anxiety. Early detention of anxiety symptoms in the perinatal stage can help prevent the development of more serious mental health problems. However, there are barriers to accessing interventions during this period. A long-distance intervention carried out during the pregnancy can be an effective and accessible resource to help improve women's emotional state. The primary objective of the current study is to determine whether a preventive psychological intervention developed through videoconferencing is superior to the usual care during pregnancy (attendance at pregnancy follow-up consultations and information and answers to frequently asked questions provided by the midwife) to prevent anxious symptoms during pregnancy. The secondary objective is to examine whether this same intervention is more effective than usual care in preventing depressive symptoms during pregnancy, as well as anxious and depressive symptoms in the postpartum.
A random clinical trial will be carried out among pregnant women in Spain. A recruitment of 130 participants is proposed with random assignment to one of two conditions (65 per group): (a) the experimental group will receive the cognitive-behavioral intervention via videoconference or (b) the control group will receive usual care pregnancy (attendance at pregnancy follow-up consultations and information and answers to frequently asked questions provided by the midwife).
The psychological intervention will take place via videoconference in seven weekly sessions, lasting one hour each, with groups of 6 - 8 pregnant women. A blinded assessment will be conducted through online self-administered testing at baseline, post-intervention, and at follow-up at one month, 3 and 6 months. A clinical interview will also be conducted to evaluate generalized anxiety disorder (GAD), at the same time times. Our primary hypothesis is that the intervention will decrease the frequency of women who present anxious symptomatology during pregnancy. The second objective is to analyze the effectiveness of this intervention to prevent depressive symptomatology during pregnancy, as well as postpartum anxious and depressive symptomatology.
详细描述
Anxiety is one of the most frequent disorders during the perinatal stage. Its prevalence is between 15% and 23% during the pregnancy, and between 3,7% and 15,0% during postpartum. In Spain, the prevalence of anxiety ranges from 16.8% to 19.5% throughout pregnancy. Additionally, one in ten women will experience comorbid anxiety and depression during pregnancy and one in twelve during the postpartum period. Although its prevalence is high, research in treating anxiety during this period is recent.
Perinatal anxiety is associated with adverse health effects for women and their babies. Regarding mothers, it has been associated to an increased probability of developing postpartum depression, a higher risk of preeclampsia, obstetric complications and bonding problems. As for newborns, they have been found to be more likely to have lower birth weight and poor cognitive development, among others. Hence the importance of detecting and intervening early in prenatal anxiety to promote the well-being of mothers and children, because despite the negative consequences associated with perinatal anxiety, the majority of women are not detected or treated, as less than 15% receive treatment. Given the high prevalence of prenatal anxiety and the potential for adverse consequences, early treatment is recommended. Evidence on the effectiveness of psychological interventions during pregnancy is scarce highlighting the importance of having specific interventions.
The National Institute for Health and Clinical Excellence recommends psychological interventions, such as cognitive behavioral therapy, as a first-line treatment for mild and moderate prenatal anxiety. Early detention of anxiety symptoms in the perinatal stage can help prevent the development of more serious mental health problems.
During pregnancy, women frequently go to health services and are more willing to receive help because they believe it will have a positive impact on their baby. However, there are barriers to accessing interventions during this period, such as lack of information about emotional problems, available and effective intervention options, as well as practical limitations of access to in-person treatment, such as costs, geographical distance, waiting lists or logistical problems such as attending appointments. Furthermore, due to the stigmatization of mental health, especially during the perinatal period, women are reluctant to attend specialized mental health clinics in person.
The advances in information and communication technologies make it possible to have interventions via the internet, which can be carried out through computers, tablets or smartphones. They have the advantage of helping to overcome the aforementioned barriers, since they improve the acceptance of the intervention, are more flexible and accessible. Systematic reviews of internet-based interventions during the perinatal period conclude that these interventions can reduce anxiety among mothers and improve depressive and anxious symptoms.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women over 18 years of age living in the Region of Galicia (Spain)
- •Pregnant with a gestational age ≤ 16
- •Understand and speak Spanish fluently
- •Informed consent to participate in the study
- •Accessibility to the internet and a digital device ( computer, tablet or smartphone)
排除标准
- •High-risk pregnancy or twins
- •Being pharmacological treatment for anxiety and/or depression
- •Not giving their consent
结局指标
主要结局
Reduced generalized anxiety disorder
时间窗: pre-intervention (baseline: t0), post-intervention (baseline: t1), follow-up at 1 month (t2), follow-up at 3 months (t3) and follow-up at 6 months (t4).
The SCID is a semi-structured interview that determines formal diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). To diagnose generalized anxiety, you need to have had anxiety on most days in the last 6 months in at least three contexts of your daily life and show 3 of the 6 anxiety symptoms that are described in the manual. The use of such interviews improves diagnostic reliability by standardizing the assessment process and increases the diagnostic validity by facilitating the application of DSM diagnostic criteria and the systematic enquiry of symptoms that might otherwise go unnoticed.
Reduced anxiety
时间窗: pre-intervention (baseline: t0), post-intervention (baseline: t1), follow-up at 1 month (t2), follow-up at 3 months (t3) and follow-up at 6 months (t4).
The Edinburgh Depression Scale - Anxiety Subscale (EDS-3A) is the anxiety subscale of the Edinburgh Postnatal Depression Scale (EPDS). Three items (3, 4, 5) can detect anxiety in women during the perinatal period. Each of the three items has four response options (0= none, 1= somewhat, 2= quite a bit, and 3= a lot). The total score of the subscale ranges from 0 to 9. The cut-off point used in the EDS-3A to detect anxious symptomatology will be ≥ 5.
次要结局
- Reduced depression(pre-intervention (baseline: t0), post-intervention (baseline: t1), follow-up at 1 month (t2), follow-up at 3 months (t3) and follow-up at 6 months (t4).)
研究者
Alba Val Noguerol
Doctoranda
University of Santiago de Compostela
