Keyan Dharani, Habashneh Rand, El-Dardery Hafsa, Faroun Muhannad, Al-Johary Feda'a, Abualhaija Adnan, Aqel Ibrahim Said, Akhtar Aemal, Dardas Latefa Ali, Bryant Richard A
School of Psychology, University of New South Wales, Sydney, New South Wales, Australia
Institute for Family Health, King Hussein Foundation, Amman, Jordan.
BMJ Open. 2025 Aug 25;15(8):e098188. doi: 10.1136/bmjopen-2024-098188.
To pilot test a stepped care intervention and examine trial procedures in advance of a definitive randomised controlled trial (RCT). We aimed to evaluate safety, acceptability and adherence to interventions.A two-arm, single-blind, parallel, pilot RCT.Multicentre primary healthcare settings.
Adults with significant psychological distress (K10 (Kessler Psychological Distress Scale) score ≥20) were recruited in Jordan between September 2022 and February 2023.
Participants were randomised to one of two arms. The intervention arm received a stepped care programme consisting of a guided self-help programme (Doing What Matters; DWM), followed by a more intensive group programme (group Problem Management Plus; gPM+). The control arm received a guided self-help programme alone. Both intervention arms also received Enhanced Treatment as Usual that comprised referral to available community support services.
A mixed methods approach was used to examine trial procedures in preparation for a definitive RCT, evaluate safety, acceptability and adherence to interventions and examine the pattern of quantitative outcomes. The primary clinical outcome was assessor-reported depression and anxiety symptoms (Hopkins Symptom Checklist-25) at week 12.
145 distressed adults (meeting Kessler Distress Score-10 score of ≥20) were randomised to either the stepped care or the single intervention arm (86% female) on a 1:1 allocation basis. DWM was delivered over 5 weeks by trained non-specialist helpers, where participants attended on average 2.6 support calls. Those randomised to gPM+attended on average 3.3 sessions. The study demonstrated feasibility and acceptability for DWM and gPM+interventions as delivered by trained non-specialists. Although the trial was not powered to detect clinical effectiveness, the stepped care arm relative to the single intervention arm demonstrated significantly lower depression symptoms immediately after and at 3 months following intervention delivery. The study and trial procedures were acceptable to participants, non-specialists and programme staff and demonstrated feasibility of implementing such a framework in Jordan.
Findings from this trial informed a fully powered definitive RCT seeking to evaluate the clinical and cost-effectiveness of a stepped model of care in Jordan.
ACTRN12621000189820p.
在开展一项确定性随机对照试验（RCT）之前，对一种逐步护理干预措施进行预试验，并检验试验程序。我们旨在评估安全性、可接受性以及对干预措施的依从性。这是一项双臂、单盲、平行的预试验RCT，在多中心初级卫生保健机构开展。
2022年9月至2023年2月期间，在约旦招募了有显著心理困扰（凯斯勒心理困扰量表（K10）得分≥20）的成年人。
参与者被随机分配到两个组之一。干预组接受一项逐步护理计划，该计划包括一个引导式自助计划（《做重要的事》；DWM），随后是一个更强化的团体计划（团体问题管理加强版；gPM+）。对照组仅接受引导式自助计划。两个干预组还都接受了常规强化治疗，包括转介到现有的社区支持服务机构。
采用混合方法来检验试验程序，为确定性RCT做准备，评估安全性、可接受性以及对干预措施的依从性，并研究定量结局的模式。主要临床结局是第12周时评估者报告的抑郁和焦虑症状（霍普金斯症状清单-25）。
145名有心理困扰的成年人（凯斯勒心理困扰量表-10得分≥20）按1:1的比例被随机分配到逐步护理组或单一干预组（86%为女性）。DWM由经过培训的非专业助手在5周内实施，参与者平均参加了2.6次支持性电话咨询。被随机分配到gPM+的参与者平均参加了3.3次课程。该研究证明了由经过培训的非专业人员实施DWM和gPM+干预措施的可行性和可接受性。尽管该试验没有足够的效力来检测临床疗效，但与单一干预组相比，逐步护理组在干预实施后立即以及3个月时的抑郁症状明显更低。该研究和试验程序为参与者、非专业人员和项目工作人员所接受，并证明了在约旦实施这样一个框架的可行性。
该试验的结果为一项有充分效力的确定性RCT提供了信息，该RCT旨在评估约旦一种逐步护理模式的临床和成本效益。
ACTRN12621000189
