Tesera Bitew, Roxanne Keynejad, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Eshcolewyine Fekadu, Adiyam Mulushoa, Louise M Howard, Fikirte Girma, Charlotte Hanlon
{"title":"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","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":"{\"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}","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}
Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: a randomised, controlled feasibility trial in (an) antenatal care setting in rural Ethiopia.
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 .
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.