一项适应性、多臂、多阶段（MAMS）随机对照试验的研究方案，针对近期经历过自杀危机的严重精神健康问题患者，提供简短的远程心理社会干预：远程心理社会干预传递方法（RAPID）。

Study protocol for an adaptive, multi-arm, multi-stage (MAMS) randomised controlled trial of brief remotely delivered psychosocial interventions for people with serious mental health problems who have experienced a recent suicidal crisis: Remote Approaches to Psychosocial Intervention Delivery (RAPID).

机构信息

The Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.

Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

出版信息

Trials. 2024 Jul 6;25(1):460. doi: 10.1186/s13063-024-08293-5.

DOI:10.1186/s13063-024-08293-5

PMID:38971788

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11227697/

Abstract

BACKGROUND

People with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Admissions can have significant personal costs, be traumatic and are the most expensive form of mental health care. There is an urgent need for treatments to reduce suicidal thoughts and behaviours and reduce avoidable psychiatric admissions.

METHODS

A multi-stage, multi-arm (MAMS) randomised controlled trial (RCT) with four arms conducted over two stages to determine the clinical and cost effectiveness of three psychosocial treatments, compared to treatment as usual (TAU), for people with SMHP who have had recent suicidal crisis. Primary outcome is any psychiatric hospital admissions over a 6-month period. We will assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression. The remote treatments delivered over 3 months are structured peer support (PREVAIL); a safety planning approach (SAFETEL) delivered by assistant psychologists; and a CBT-based suicide prevention app accessed via a smartphone (BrighterSide). Recruitment is at five UK sites. Stage 1 includes an internal pilot with a priori progression criteria. In stage 1, the randomisation ratio was 1:1:1:2 in favour of TAU. This has been amended to 2:2:3 in favour of TAU following an unplanned change to remove the BrighterSide arm following the release of efficacy data from an independent RCT. Randomisation is via an independent remote web-based randomisation system using randomly permuted blocks, stratified by site. An interim analysis will be performed using data from the first 385 participants from PREVAIL, SAFETEL and TAU with outcome data at 6 months. If one arm is dropped for lack of benefit in stage 2, the allocation ratio of future participants will be 1:1. The expected total sample size is 1064 participants (1118 inclusive of BrighterSide participants).

DISCUSSION

There is a need for evidence-based interventions to reduce psychiatric admissions, via reduction of suicidality. Our focus on remote delivery of established brief psychosocial interventions, utilisation of different modalities of delivery that can provide sustainable and scalable solutions, which are also suitable for a pandemic or national crisis context, will significantly advance treatment options.

TRIAL REGISTRATION

ISRCTN33079589. Registered on June 20, 2022.

摘要

背景

有严重精神健康问题的人（SMHP）在与危机服务机构接触后更有可能被送进精神病院。住院治疗会带来重大的个人成本，带来创伤，而且是最昂贵的精神健康护理形式。因此，我们急需治疗方法来减少自杀念头和行为，减少不必要的精神病住院治疗。

方法

这是一项多阶段、多臂（MAMS）随机对照试验（RCT），分两个阶段进行，共有四个组，旨在确定三种心理社会治疗方法与常规治疗（TAU）相比，对近期有自杀危机的 SMHP 患者的临床和成本效益。主要结局是在 6 个月内任何精神病院的入院情况。我们将评估对自杀念头和行为、希望、康复、焦虑和抑郁的影响。为期 3 个月的远程治疗方法是结构化同伴支持（PREVAIL）；由助理心理学家提供的安全计划方法（SAFETEL）；以及通过智能手机访问的基于 CBT 的自杀预防应用程序（BrighterSide）。研究在英国五个地点进行。第一阶段包括一个预先设定了进展标准的内部试验。在第一阶段，随机分组的比例是 1:1:1:2，有利于 TAU。在 BrighterSide 臂由于一项独立 RCT 的疗效数据公布后被取消后，这一比例已更改为 2:2:3，有利于 TAU。随机分组是通过一个独立的远程网络随机分组系统进行的，使用随机排列的块，按地点分层。如果在第二阶段发现某一组没有效果，将进行中期分析，分析数据来自 PREVAIL、SAFETEL 和 TAU 的前 385 名参与者，结局数据为 6 个月。如果在第二阶段有一组因无效而被淘汰，未来参与者的分配比例将为 1:1。预计总样本量为 1064 名参与者（包括 BrighterSide 参与者在内共 1118 名）。