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检验一项针对卡塔尔多哈女性的文化适应性循证产后抑郁预防干预措施的可行性、可接受性及初步结果:一项随机对照试验方案

Examining Feasibility, Acceptability, and Preliminary Outcomes of a Culturally Adapted Evidence-Based Postpartum Depression Preventive Intervention for Women in Doha, Qatar: Protocol for a Randomized Controlled Trial.

作者信息

Ahmed Sawssan R, Watt Felice, Mahfoud Ziyad Riyad, Korayem Mona, Buhmaid Sara, Alberry Medhat, Ibrahim Ibrahim Mamoun, Tandon S Darius

机构信息

Department of Psychology, California State University-Fullerton, Fullerton, CA, United States.

Sidra Medicine, Doha, Qatar.

出版信息

JMIR Res Protoc. 2023 Aug 11;12:e11623. doi: 10.2196/11623.

Abstract

BACKGROUND

Postpartum depression and anxiety are the 2 most common perinatal mental health disorders, with prevalence rates higher among women living in the Middle East than in most Western countries. The negative outcomes associated with postpartum depression and anxiety are profound and include less responsive parenting and compromised infant and young child development. Although interventions exist to prevent postpartum depression and anxiety, to date, there have been no studies that have attempted to prevent postpartum depression or anxiety among Arabic-speaking women in the Middle East, including Qatar.

OBJECTIVE

The purpose of this study is to conduct a randomized controlled trial (RCT) of an evidence-based postpartum depression preventive intervention-Mothers and Babies (MB)-culturally adapted for use with Arabic-speaking women in Doha, Qatar. MB is guided by a cognitive behavioral therapy framework that focuses on increasing pleasant activities, promoting healthy thought patterns, and increasing the type and frequency of personal contacts. MB is tailored to specific needs and issues related to pregnancy and the postpartum period.

METHODS

A multidisciplinary and multiethnic investigator team adapted MB to promote cultural and contextual fit for Arabic-speaking women. Intervention concepts were reviewed to ensure core content would be understood by Arabic-speaking women in Qatar. Subsequently, images, activities, and examples in the intervention manuals were adapted, as needed, to make the content more relevant to Arab culture. To deliver the adapted intervention, 30 Arabic-speaking individuals with mental health backgrounds were trained. The adapted intervention was subsequently pilot-tested with 10 pregnant women receiving prenatal care at Sidra Hospital in Doha. We are now conducting an RCT to examine the effectiveness of the adapted intervention. We plan to enroll 210 pregnant individuals who are Arabic-speaking, with 1:1 randomization to the MB intervention or usual prenatal care. Among the enrolled participants, a stratified subsample of 40 pregnant women with diabetes is being recruited. Data collection will take place at baseline and a 6-month follow-up. The primary outcomes are depressive and anxiety symptoms and perceived stress. Diabetes self-care is the exploratory outcome for the subsample of individuals with diabetes. Intervention implementation will be assessed via client and provider surveys during and after intervention delivery. Power and sample size were calculated using a 2-sided 5% effort rate and assumed analyses on the individual level, accounting for attrition of 20%.

RESULTS

The cultural adaptation and pilot study of the adapted MB intervention are completed. A total of 157 women have been enrolled in the RCT as of March 31, 2023.

CONCLUSIONS

This study is highly innovative, as it is the first study to our knowledge to examine the effectiveness of an evidence-based postpartum depression preventive intervention in the Middle East. Limitations include a single follow-up time point and a small subsample of individuals with diabetes.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04442529; https://www.clinicaltrials.gov/study/NCT04442529.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11623.

摘要

背景

产后抑郁和焦虑是两种最常见的围产期心理健康障碍,中东地区女性的患病率高于大多数西方国家。产后抑郁和焦虑带来的负面后果很严重,包括育儿反应性降低以及婴幼儿发育受损。尽管存在预防产后抑郁和焦虑的干预措施,但迄今为止,尚无研究试图在中东地区(包括卡塔尔)预防讲阿拉伯语女性的产后抑郁或焦虑。

目的

本研究旨在开展一项随机对照试验(RCT),对一种循证产后抑郁预防干预措施——母婴(MB)进行文化调适,以用于卡塔尔多哈讲阿拉伯语的女性。MB以认知行为疗法框架为指导,重点是增加愉快活动、促进健康思维模式以及增加人际接触的类型和频率。MB针对与怀孕和产后时期相关的特定需求和问题进行了调整。

方法

一个多学科、多民族的研究团队对MB进行了调适,以促进其与讲阿拉伯语女性的文化和背景相契合。对干预概念进行了审查,以确保卡塔尔讲阿拉伯语的女性能够理解核心内容。随后,根据需要对干预手册中的图片、活动和示例进行了调整,以使内容与阿拉伯文化更相关。为了实施调适后的干预措施,对30名有心理健康背景的讲阿拉伯语人员进行了培训。随后,对在多哈西德拉医院接受产前护理的10名孕妇进行了调适后干预的试点测试。我们目前正在进行一项RCT,以检验调适后干预措施的有效性。我们计划招募210名讲阿拉伯语的孕妇,以1:1的比例随机分配到MB干预组或常规产前护理组。在招募的参与者中,正在招募一个由40名患有糖尿病的孕妇组成的分层子样本。数据收集将在基线和6个月随访时进行。主要结局是抑郁和焦虑症状以及感知压力。糖尿病自我护理是糖尿病患者子样本的探索性结局。将通过干预实施期间和之后的客户和提供者调查来评估干预措施的实施情况。使用双侧5%的效应量率并在个体水平上进行假设分析,同时考虑20%的损耗率来计算功效和样本量。

结果

调适后MB干预措施的文化调适和试点研究已完成。截至2023年3月31日,共有157名女性参加了RCT。

结论

本研究具有高度创新性,据我们所知,这是第一项检验循证产后抑郁预防干预措施在中东地区有效性的研究。局限性包括单一的随访时间点和糖尿病患者的小样本。

试验注册

ClinicalTrials.gov NCT04442529;https://www.clinicaltrials.gov/study/NCT04442529。

国际注册报告标识符(IRRID):DERR1-10.2196/11623。

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