Pilot and feasibility studies · 2025
Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: a randomised, controlled feasibility trial in (an) antenatal care setting in rural Ethiopia.
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Bitew Tesera, Keynejad Roxanne, Sorsdahl Katherine, Myers Bronwyn, Honikman Simone, Medhin Girmay, Fekadu Eshcolewyine, Mulushoa Adiyam, Howard Louise M, Girma Fikirte, Hanlon Charlotte
Аннотация
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 .
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 .