Kingston Dawn, McDonald Sheila, Biringer Anne, Austin Marie-Paule, Hegadoren Kathy, McDonald Sarah, Giallo Rebecca, Ohinmaa Arto, Lasiuk Gerri, MacQueen Glenda, Sword Wendy, Lane-Smith Marie, van Zanten Sander Veldhuyzen
University of Alberta, 11405-87th Avenue, Edmonton, T6G 1C9, Canada.
Trials. 2014 Jan 2;15:3. doi: 10.1186/1745-6215-15-3.
Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed.
METHODS/DESIGN: The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening.
ClinicalTrials.gov Identifier: NCT01899534.
压力、抑郁和焦虑影响着15%至25%的孕妇。然而，心理社会评估存在重大障碍，导致不到20%的产前护理提供者对心理健康问题进行评估和治疗。此外，孕妇通常不愿向医疗服务提供者透露其心理健康问题。因此，需要确定对女性和服务提供者都可接受、具有成本效益且具有临床实用性的筛查和评估工具及程序。
方法/设计：这项随机、平行组、优效性试验的主要目的是评估基于电脑平板电脑的产前心理社会评估（电子筛查）与纸质筛查相比的可行性和可接受性。次要目的是比较两种筛查方式在以下方面的情况：（1）产前抑郁和焦虑症状及心理社会风险的检测水平；（2）症状的披露程度；（3）与可行性、可接受性和披露相关的因素；（4）评估工具电子版的心理测量特性；（5）成本效益。将从加拿大一个城市的大型初级保健产科诊所和高危产前病房招募542名女性作为样本。符合以下条件的孕妇有资格参与：（1）在其中一个招募地点接受护理；（2）能够说/读英语；（3）愿意被随机分配到电子筛查组；（4）愿意在招募后1周内参加后续诊断访谈。通过计算机生成随机数进行分配。干预组的女性将在电脑平板电脑上完成在线心理社会评估，而对照组的女性将以纸质形式完成相同评估。所有女性在招募时都将完成基线问卷，并在招募后1周内参加诊断访谈。进行诊断访谈的研究助理和医生将处于盲态。一项涉及招募地点的医疗服务提供者和女性的定性描述性研究将提供关于干预措施可行性和可接受性的数据。我们假设，与纸质筛查相比，在初级保健产科环境和高危产前病房进行心理健康电子筛查将同样或更具可行性、可接受性，并且能够检测出抑郁、焦虑和心理社会风险。
ClinicalTrials.gov标识符：NCT01899534。
