Pyle Melissa, Corrigan Patrick W, Wood Lisa, Pilling Stephen, Murphy Elizabeth, Macafee Gillian, Kelly Kate, Byrne Rory, Dunbar Eleanor, Jones Emily, Hudson Jemma, Jones Wendy, Hazzard Raj, Larson Jon E, MacLennan Graeme, Swingler James, Peters Sarah, Morrison Anthony P
The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Prestwich, M25 3BL, UK.
Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, M13 9PL, UK.
Psychol Med. 2024 Dec 27;54(16):1-12. doi: 10.1017/S0033291724002605.
Stigma of mental health conditions hinders recovery and well-being. The Honest, Open, Proud (HOP) program shows promise in reducing stigma but there is uncertainty about the feasibility of a randomized trial to evaluate a peer-delivered, individual adaptation of HOP for psychosis (Let's Talk).
A multi-site, Prospective Randomized Open Blinded Evaluation (PROBE) design, feasibility randomised controlled trial (RCT) comparing the peer-delivered intervention (Let's Talk) to treatment as usual (TAU). Follow-up was 2.5 and 6 months. Randomization was via a web-based system, with permuted blocks of random size. Up to 10 sessions of the intervention over 10 weeks were offered. The primary outcome was feasibility data (recruitment, retention, intervention attendance). Primary outcomes were analyzed by intention to treat. Safety outcomes were reported by as treated status. The study was prospectively registered: https://doi.org/10.1186/ISRCTN17197043.
149 patients were referred to the study and 70 were recruited. 35 were randomly assigned to intervention + TAU and 35 to TAU. Recruitment was 93% of the target sample size. Retention rate was high (81% at 2.5 months primary endpoint), and intervention attendance rate was high (83%). 21% of 33 patients in Let's talk + TAU had an adverse event and 16% of 37 patients in TAU. One serious adverse event (pre-randomization) was partially related and expected.
This is the first trial to show that it is feasible and safe to conduct a RCT of HOP adapted for people with psychosis and individual delivery. An adequately powered trial is required to provide robust evidence.
心理健康问题的污名化阻碍康复和幸福。“诚实、开放、自豪”（HOP）项目在减少污名化方面显示出前景，但对于评估针对精神病患者的同伴提供的HOP个体化改编版（“畅所欲言”）进行随机试验的可行性存在不确定性。
一项多中心、前瞻性随机开放盲法评估（PROBE）设计的可行性随机对照试验（RCT），将同伴提供的干预措施（“畅所欲言”）与常规治疗（TAU）进行比较。随访时间为2.5个月和6个月。随机化通过基于网络的系统进行，采用随机大小的置换区组。在10周内提供最多10次干预课程。主要结局是可行性数据（招募、留存、干预课程参与情况）。主要结局采用意向性分析。安全性结局按实际治疗情况报告。该研究已进行前瞻性注册：https://doi.org/10.1186/ISRCTN17197043。
149名患者被转诊至该研究，70名被招募。35名被随机分配至干预+TAU组，35名被分配至TAU组。招募人数达到目标样本量的93%。留存率较高（在2.5个月的主要终点时为81%），干预课程参与率也较高高中心率变异性较高（83%）。在“畅所欲言”+TAU组的33名患者中有21%发生不良事件，在TAU组的37名患者中有16%发生不良事件。1例严重不良事件（随机分组前）部分相关且在意料之中。
这是第一项表明对适用于精神病患者且为个体化提供的HOP进行RCT是可行且安全的试验。需要进行一项有足够效力的试验以提供有力证据。
