Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial.
Brief problem-solving therapy for antenatal depressive symptoms in primary care in rural Ethiopia: protocol for a randomised, controlled feasibility trial.
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DOI：
10.1186/s40814-021-00773-8
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发表时间：
2021-01-30
影响因子：
1.7
通讯作者：
Hanlon C
中科院分区：
文献类型：
--
作者：
Bitew T;Keynejad R;Myers B;Honikman S;Medhin G;Girma F;Howard L;Sorsdahl K;Hanlon C
尽管产前抑郁症在低收入和中等收入国家的发病率很高，但很少有证据表明在非洲农村地区提供了适应环境的心理干预措施。本研究的目的是（1）检查程序的可行性，为未来充分的效力试验的上下文适应简短的问题解决疗法（PST）产前抑郁症在埃塞俄比亚农村，（2）调查的可接受性，保真度和可行性交付PST在常规产前护理。设计：随机、对照、可行性试验和混合方法过程评价。参与者：连续前往埃塞俄比亚农村地区两个初级保健机构产前诊所就诊的妇女。资格标准：（1）抑郁症状的致残水平（患者健康问卷（PHQ-9）评分为5分或以上，第10项残疾项目为阳性）;（2）胎龄12-34周;（3）年龄16岁及以上;（4）计划在研究区域生活至少6个月;（5）无严重的医疗或精神疾病。干预措施：由经过培训和监督的产前护理人员在最长8周的时间内提供四次适应性PST。对照组：加强常规护理（EUC）。样本量：n = 50。随机化：按亲密伴侣暴力（IPV）分层的个体随机化。分配：中央电话分配。结局评估者和统计学家对分配状态设盲。主要可行性试验结局：脱落率。主要未来疗效试验结局：招募后9周评估的PHQ-9评分变化。次要结局：焦虑症状、创伤症状、亲密伴侣暴力、残疾、9周时的医疗保健费用;产后4-6周评估的产后结果（围产期和新生儿并发症、母乳喂养开始、儿童健康）。其他试验可行性指标：招募、参加会议的次数和持续时间。将对随机选择的会议录音和对有目的选择的参与者、医疗保健提供者和监督者的深入访谈进行主题分析，以探讨试验程序的可接受性和可行性以及PST交付的保真度。该研究的结果将用于为埃塞俄比亚农村地区常规护理中的产前抑郁症的短暂PST的充分功效试验的设计提供信息。该方案于2020年8月18日在泛非临床试验注册中心（PACTR）注册：注册号：PACTR 202008712234907; URL：https://pactr.samrc.ac.za/TrialDisplay.aspx? TrialID=9578。在线版本包含补充材料，可通过10.1186/s40814-021-00773-8获得。
Despite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. The aims of this study are (1) to examine the feasibility of procedures for a future fully powered efficacy trial of contextually adapted brief problem solving therapy (PST) for antenatal depression in rural Ethiopia, and (2) to investigate the acceptability, fidelity and feasibility of delivery of PST in routine antenatal care. Design: A randomised, controlled, feasibility trial and mixed method process evaluation. Participants: Consecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: (1) disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) score of five or more and positive for the 10th disability item); (2) gestational age 12–34 weeks; (3) aged 16 years and above; (4) planning to live in the study area for at least 6 months; (5) no severe medical or psychiatric conditions. Intervention: Four sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks. Control: enhanced usual care (EUC). Sample size: n = 50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed 9 weeks after recruitment. Secondary outcomes: anxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4–6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording of randomly selected sessions and in-depth interviews with purposively selected participants, healthcare providers and supervisors will be analysed thematically to explore the acceptability and feasibility of the trial procedures and fidelity of the delivery of PST. The findings of the study will be used to inform the design of a fully powered efficacy trial of brief PST for antenatal depression in routine care in rural Ethiopia. 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 online version contains supplementary material available at 10.1186/s40814-021-00773-8.