Steardo Luca, Caivano Vito, Sampogna Gaia, Di Cerbo Arcangelo, Fico Giovanna, Zinno Francesca, Del Vecchio Valeria, Giallonardo Vincenzo, Torella Marco, Luciano Mario, Fiorillo Andrea
Department of Psychiatry, University of Campania Luigi Vanvitelli, Naples, Italy.
Department of Gynecology, University of Campania Luigi Vanvitelli, Naples, Italy.
Front Psychiatry. 2019 Feb 13;10:55. doi: 10.3389/fpsyt.2019.00055. eCollection 2019.
Perinatal depression (PD) is a severe and disabling condition impacting negatively on children in terms of adverse neonatal outcomes and on the well-being of women and their families. All pregnant women attending the unit of Gynecology and Obstetrics Service of the University of Campania "L. Vanvitelli" will be screened for PD using the Edinburgh Postpartum Depression Scale (EPDS). Women with a score ≥10 at the EPDS will be invited to receive a full psychiatric assessment. The required sample size is of 126 women with PD which will be randomly allocated to either an experimental group, receiving a uni-familiar psychoeducational intervention, or to a control group, receiving the Best Treatment Option (BTO). Patients will be evaluated through several assessment instruments: Hamilton Depression Rating Scale (HAM-D), Hamilton Anxiety Rating Scale (HAM-A), Global Assessment of Functioning (GAF), Clinical Global Impression (CGI), Manchester Short Assessment of Quality of Life (MANSA), Family Assessment Device (FAD), Family Coping Questionnaire (FCQ), and Pattern of Care Schedule (PCS). Patients will be evaluated at baseline, 3, 6, 9, and 12 months post-randomization. The severity of depressive symptoms at the HAM-D scale has been selected as primary outcome. Other outcome measures include improvement in the severity of anxiety symptoms, of global and personal functioning, an improvement in family members' coping strategies and in the level of quality of life. It has been highlighted the importance of developing screening and treating programs for PD, and our study will use rigorous study design to evaluate the efficacy of the adaption of a well-known family psychoeducational model to the treatment of PD. The aims of present trial are to: (1) develop an informative package for pregnant women with PD; (2) promote a screening programme for PD; (3) identify those (socio-demographic and pregnancy-related environmental) factors associated with a higher risk to develop a perinatal or postnatal depression; (4) evaluate the efficacy of a new experimental psychoeducational intervention in reducing the depressive symptoms during pregnancy compared to the BTO.
围产期抑郁症（PD）是一种严重且致残的疾病，在新生儿不良结局方面对儿童产生负面影响，同时也影响女性及其家庭的幸福。坎帕尼亚大学“L. 万维泰利”妇产科服务部门接待的所有孕妇都将使用爱丁堡产后抑郁量表（EPDS）进行PD筛查。EPDS得分≥10分的女性将被邀请接受全面的精神科评估。所需样本量为126名患有PD的女性，她们将被随机分配到实验组或对照组，实验组接受单家庭心理教育干预，对照组接受最佳治疗方案（BTO）。患者将通过多种评估工具进行评估：汉密尔顿抑郁评定量表（HAM-D）、汉密尔顿焦虑评定量表（HAM-A）、功能总体评定量表（GAF）、临床总体印象量表（CGI）、曼彻斯特生活质量简短评定量表（MANSA）、家庭评估工具（FAD）、家庭应对问卷（FCQ）和护理模式时间表（PCS）。患者将在随机分组后的基线、3、6、9和12个月进行评估。以HAM-D量表评估的抑郁症状严重程度被选为主要结局。其他结局指标包括焦虑症状严重程度、总体和个人功能的改善，家庭成员应对策略的改善以及生活质量水平的提高。已强调了制定PD筛查和治疗方案的重要性，我们的研究将采用严谨的研究设计来评估一种知名的家庭心理教育模式应用于PD治疗的效果。本试验的目的是：（1）为患有PD的孕妇制定一份信息包；（2）推广PD筛查项目；（3）确定那些（社会人口统计学和与妊娠相关的环境）与发生围产期或产后抑郁症风险较高相关的因素；（4）评估一种新的实验性心理教育干预与BTO相比在减轻孕期抑郁症状方面的疗效。
