Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: a randomised, controlled feasibility trial in (an) antenatal care setting in rural Ethiopia.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Tesera Bitew, Roxanne Keynejad, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Eshcolewyine Fekadu, Adiyam Mulushoa, Louise M Howard, Fikirte Girma, Charlotte Hanlon
{"title":"Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: a randomised, controlled feasibility trial in (an) antenatal care setting in rural Ethiopia.","authors":"Tesera Bitew, Roxanne Keynejad, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Eshcolewyine Fekadu, Adiyam Mulushoa, Louise M Howard, Fikirte Girma, Charlotte Hanlon","doi":"10.1186/s40814-025-01672-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>We adapted non-specialist healthcare worker (HCW) delivered problem-solving therapy (PST) to support improved treatment of antenatal depression in maternal healthcare platforms in rural Ethiopia. In this study, we aimed to evaluate the feasibility, fidelity, and acceptability of PST for antenatal depression and the procedures required for the implementation of a fully-powered randomised controlled trial (RCT).</p><p><strong>Methods: </strong>Participants were consecutive antenatal care (ANC) attendees in two primary healthcare (PHC)-based healthcare facilities, based on pre-established eligibility criteria. We employed a randomised, controlled feasibility trial design with two parallel groups. Participants in the intervention arm received four sessions of a contextually adapted version of PST; the control group received enhanced usual care (EUC) that involved routine antenatal care and information about sources of support. Assessments were conducted at baseline (T<sub>0</sub>) and at 9 weeks after randomisation (T<sub>1</sub>). Assessment at T<sub>1</sub> mainly comprised of preliminary clinical outcomes and hypothesized mediators. At T<sub>2</sub>, feasibility parameters were assessed in addition to T<sub>1</sub> assessments. A recruitment rate of 80% of the expected sample size within a month, retention rate of ≥ 50%, provider competence of ≥ 60%, less than 10% adverse events and mean session duration of 30 min were assumed for feasibility success. We summarised participant characteristics, feasibility outcomes, and preliminary clinical outcomes using descriptive statistics.</p><p><strong>Results: </strong>After screening and the consent process, we randomised 50 eligible women to PST and EUC arms. Trial procedures such as participant recruitment and allocation concealment were feasible. Most (64%) completed all four sessions of the intervention. About 58% of HCWs attained expected scores on Enhancing Assessment of Common Therapeutic factors (ENACT) scale. No adverse events occurred during the trial. Supervision reports indicated that HCWs appreciated skills gained from PST and adhered to most of the PST content, except challenging women who reported not having problems or worries. However, they recommended pre-recorded videos of role play demonstrations and shorter trainer demonstrations, to increase trainees' opportunities to practise skills.</p><p><strong>Conclusions: </strong>Participant recruitment, screening, randomisation, masking, as well as the intervention delivery process, were feasible. Future training should prioritise opportunities for HCWs to practise skills as much as possible. https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8 TRIAL REGISTRATION: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 . The protocol has also been published: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"121"},"PeriodicalIF":1.6000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01672-y","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: We adapted non-specialist healthcare worker (HCW) delivered problem-solving therapy (PST) to support improved treatment of antenatal depression in maternal healthcare platforms in rural Ethiopia. In this study, we aimed to evaluate the feasibility, fidelity, and acceptability of PST for antenatal depression and the procedures required for the implementation of a fully-powered randomised controlled trial (RCT).

Methods: Participants were consecutive antenatal care (ANC) attendees in two primary healthcare (PHC)-based healthcare facilities, based on pre-established eligibility criteria. We employed a randomised, controlled feasibility trial design with two parallel groups. Participants in the intervention arm received four sessions of a contextually adapted version of PST; the control group received enhanced usual care (EUC) that involved routine antenatal care and information about sources of support. Assessments were conducted at baseline (T0) and at 9 weeks after randomisation (T1). Assessment at T1 mainly comprised of preliminary clinical outcomes and hypothesized mediators. At T2, feasibility parameters were assessed in addition to T1 assessments. A recruitment rate of 80% of the expected sample size within a month, retention rate of ≥ 50%, provider competence of ≥ 60%, less than 10% adverse events and mean session duration of 30 min were assumed for feasibility success. We summarised participant characteristics, feasibility outcomes, and preliminary clinical outcomes using descriptive statistics.

Results: After screening and the consent process, we randomised 50 eligible women to PST and EUC arms. Trial procedures such as participant recruitment and allocation concealment were feasible. Most (64%) completed all four sessions of the intervention. About 58% of HCWs attained expected scores on Enhancing Assessment of Common Therapeutic factors (ENACT) scale. No adverse events occurred during the trial. Supervision reports indicated that HCWs appreciated skills gained from PST and adhered to most of the PST content, except challenging women who reported not having problems or worries. However, they recommended pre-recorded videos of role play demonstrations and shorter trainer demonstrations, to increase trainees' opportunities to practise skills.

Conclusions: Participant recruitment, screening, randomisation, masking, as well as the intervention delivery process, were feasible. Future training should prioritise opportunities for HCWs to practise skills as much as possible. https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8 TRIAL REGISTRATION: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 . The protocol has also been published: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8 .

对出现产前抑郁症状的妇女进行简短问题解决疗法(PST):在埃塞俄比亚农村产前保健机构进行的一项随机对照可行性试验
背景:我们采用非专业医护人员(HCW)提供的问题解决疗法(PST)来支持改善埃塞俄比亚农村孕产妇保健平台对产前抑郁症的治疗。在这项研究中,我们旨在评估PST治疗产前抑郁症的可行性、保真度和可接受性,以及实施一项全功率随机对照试验(RCT)所需的程序。方法:参与者是连续产前保健(ANC)参与者在两个初级卫生保健(PHC)为基础的卫生保健设施,基于预先建立的资格标准。我们采用随机对照可行性试验设计,分为两个平行组。干预组的参与者接受了四次情境改编版PST;对照组接受强化常规护理(EUC),包括常规产前护理和有关支持来源的信息。在基线(T0)和随机化后9周(T1)进行评估。T1时的评估主要包括初步临床结果和假设的介质。在T2时,除T1评估外,还评估了可行性参数。假设在一个月内招募率达到预期样本量的80%,保留率≥50%,提供者能力≥60%,不良事件少于10%,平均疗程持续时间为30分钟,即可获得可行性成功。我们使用描述性统计总结了参与者的特征、可行性结果和初步临床结果。结果:经过筛选和同意程序,我们将50名符合条件的妇女随机分配到PST和EUC组。试验程序如参与者招募和分配隐藏是可行的。大多数(64%)完成了所有四个疗程的干预。约58%的医护人员达到了共同治疗因素强化评估(ENACT)量表的预期得分。试验期间未发生不良事件。监督报告表明,卫生保健工作者欣赏从PST中获得的技能,并遵守大部分PST内容,除了挑战那些报告没有问题或担忧的妇女。然而,他们推荐预先录制的角色扮演示范视频和较短的培训师示范,以增加学员练习技能的机会。结论:参与者招募、筛选、随机化、屏蔽以及干预递送过程是可行的。未来的培训应优先为卫生工作者提供尽可能多的练习技能的机会。https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8试验注册:该方案已于2020年8月18日在泛非临床试验注册中心(PACTR)注册:PACTR202008712234907;网址:https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578。该议定书也已公布:https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信