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一项针对法医精神病住院服务中患有严重精神疾病的成年人的多学科体重管理干预措施(Motiv8):一项单盲整群随机等待名单对照可行性试验。

A multidisciplinary weight management intervention for adults with severe mental illness in forensic psychiatric inpatient services (Motiv8): a single blind cluster-randomised wait-list controlled feasibility trial.

作者信息

Carney Rebekah, Law Heather, El-Metaal Hany, Hann Mark, Shields Gemma, Savage Siobhan, Small Ingrid, Jones Richard, Shiers David, Macafee Gillian, Parker Sophie

机构信息

Youth Mental Health Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester, United Kingdom.

Division of Psychology and Mental Health, University of Manchester, Manchester, United Kingdom.

出版信息

Front Psychiatry. 2024 Nov 18;15:1457864. doi: 10.3389/fpsyt.2024.1457864. eCollection 2024.

Abstract

BACKGROUND

People with severe mental illness experience physical health inequalities and a 15-20-year premature mortality rate. Forensic inpatients are particularly affected by restrictions on movement, long admissions, and obesogenic/sedative psychotropic medication. We aimed to establish the feasibility and acceptability of Motiv8, a multidisciplinary weight management intervention co-produced with service users for forensic inpatients.

METHODS

A randomised waitlist-controlled trial of Motiv8(+Treatment-As-Usual) vs.TAU was conducted in medium-secure forensic services in Greater Manchester. Motiv8 is a 9-week programme of exercise sessions, diet/cooking classes, psychology, physical health/sleep education, and peer support. Physical and mental health assessments were conducted at baseline/10-weeks/3-months. A nested qualitative study captured participant experiences. A staff sub-study explored ward environment.

RESULTS

We aimed to recruit 32 participants (four cohorts). The trial met recruitment targets (n=29, 90.9%; 4 cohorts, 100%), participants were randomised to Motiv8+TAU (n=12) or waitlist (control) (n=17). Acceptable retention rates were observed (93.1%, 10-weeks; 72.4%, 3-months), and participants engaged well with the intervention. The blind was maintained, and no safety concerns raised. Assessment completion was high suggesting acceptability (>90% for people retained and engaged in the study). Participants reported high levels of satisfaction.

CONCLUSIONS

The trial was not powered to detect group differences. However, data suggests it is feasible to conduct a rigorous, methodologically robust study of Motiv8 vs.TAU for adults on forensic inpatient units. Motiv8 was acceptable with potential promise providing evidence to proceed to a definitive trial for males. A larger trial is needed to explore potential effectiveness and reduce physical health inequalities for people with SMI.

CLINICAL TRIAL REGISTRATION

https://doi.org/10.1186/ISRCTN13539285, identifier ISRCTN13539285.

摘要

背景

患有严重精神疾病的人群存在身体健康不平等问题,且过早死亡率达15 - 20年。法医住院患者尤其受到行动限制、长期住院以及致胖/镇静类精神药物的影响。我们旨在确定Motiv8的可行性和可接受性,Motiv8是一项与服务使用者共同制定的针对法医住院患者的多学科体重管理干预措施。

方法

在大曼彻斯特的中等安全级别的法医服务机构中进行了一项Motiv8(+常规治疗)与常规治疗(TAU)的随机等待列表对照试验。Motiv8是一个为期9周的项目,包括锻炼课程、饮食/烹饪课程、心理学、身体健康/睡眠教育以及同伴支持。在基线/10周/3个月时进行身心健康评估。一项嵌套的定性研究记录了参与者的经历。一项工作人员子研究探讨了病房环境。

结果

我们的目标是招募32名参与者(四个队列)。该试验达到了招募目标(n = 29,90.9%;4个队列,100%),参与者被随机分配到Motiv8 + TAU组(n = 12)或等待列表(对照组)(n = 17)。观察到了可接受的保留率(10周时为93.1%;3个月时为72.4%),并且参与者对干预措施的参与度良好。保持了盲法,未提出安全问题。评估完成率很高,表明可接受性(对于参与并留在研究中的人>90%)。参与者报告了高度的满意度。

结论

该试验没有足够的效力来检测组间差异。然而,数据表明,对法医住院单元的成年人进行Motiv8与TAU的严格、方法学上稳健的研究是可行的。Motiv8是可接受的,具有潜在前景,为男性进行确定性试验提供了证据。需要进行更大规模的试验来探索潜在效果,并减少患有严重精神疾病人群的身体健康不平等问题。

临床试验注册

https://doi.org/10.1186/ISRCTN13539285,标识符ISRCTN13539285。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e82/11609147/1e5379e6fec6/fpsyt-15-1457864-g001.jpg

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