Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Mental Disorders
研究概览
简要总结
The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals.
Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers.
Participants will:
- Take baseline questionnaires at 2-4 weeks postpartum
- Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum
- Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up
- Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous women
- •Given birth a healthy, full-term baby in the preceding 2 weeks
- •Receiving postpartum healthcare at Atenció a la salut sexual i reproductiva (ASSIR) of Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
- •Over 18 years of age
- •Give consent to participate in the study
排除标准
- •If are unable to complete the questionnaires due to language or literacy barriers
结局指标
主要结局
Mental Disorders
时间窗: 3 and 6 months postpartum (follow-up)
The Mini-International Neuropsychiatric Interview (MINI) is a brief structured interview designed for the detection and diagnostic guidance of major Axis I psychiatric disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) and the International Classification of Diseases, 10th Edition (ICD-10). It has an administration time of approximately 15 minutes and is divided into 16 modules, identified by letters, each corresponding to a diagnostic category.
Anxiety symptoms
时间窗: Baseline, 3 and 6 months follow-up
The Generalised Anxiety Disorder Screener (GAD-7) is a 7-item self-report scale used as a screening instrument measuring symptoms of generalized anxiety disorder that has been recommended as brief screening measure for perinatal anxiety. Item scores are summed up to a total score (from 0 to 21 points), with higher scores indicating a higher anxiety symptom burden. There are no cut-off points established for the Spanish version. In the original version, the authors propose a cut-off point of greater than or equal to 10. For the Spanish version, a Cronbach's alpha coefficient of 0.93 was obtained. Considering the 10-point cutoff, sensitivity values of 86.8% and specificity of 93.4% were found.
Depressive symptoms
时间窗: Baseline, 3 and 6 months follow-up
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire that is used as a screening instrument and for research purposes. Item scores are summed up to a total score (from 0 to 30 points), with higher scores indicating a higher depressive symptom burden. At a cutoff value of 11 (EPDS ≥ 11), the sensitivity of detecting a clinically significant depression is 0.79, the specificity is 0.95, and the positive predictive value is 0.63. The scale has a good internal consistency (Cronbach's α = 0.81).
次要结局
- Parenting self-regulation(Baseline, 3 and 6 months follow-up)
- Maternal postpartum bonding(Baseline, 3 and 6 months follow-up)
- Satisfaction survey(Intervention group participants immediately after completing the WWWT psychoeducative group.)
- Marital Adjustment(Baseline, 3 and 6 months follow-up)
研究者
Alba Roca
Doctor
Fundacion Clinic per a la Recerca Biomédica