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)

被引：0

作者：

Pyle, Melissa ^{[1
]}

Loftus, Lucy ^{[1
]}

Emsley, Richard ^{[2
]}

Freeman, Daniel ^{[3
,4
]}

Gillard, Steven ^{[5
]}

Gumley, Andrew ^{[6
]}

Sierpatowska, Justyna ^{[7
]}

Wood, Lisa ^{[8
,9
]}

O'Connor, Rory C. ^{[6
]}

Pfeiffer, Paul ^{[10
,11
]}

Simpson, Sharon Anne ^{[6
]}

Cockayne, Nicole ^{[12
]}

Shields, Gemma ^{[13
]}

Beckley, Ariane ^{[3
]}

Beckwith, Helen ^{[3
,4
]}

Filippidou, Maria ^{[7
]}

Glen, Callum ^{[2
]}

Allan, Stephanie ^{[6
]}

Hazzard, Raj ^{[14
]}

Longden, Eleanor ^{[1
,15
]}

Peel, Heather ^{[1
]}

Larsen, Mark ^{[12
,16
]}

Bucci, Sandra ^{[15
]}

Morrison, Anthony P. ^{[1
,15
]}

机构：

[1] Greater Manchester Mental Hlth NHS Fdn Trust, Dept Psychol, Psychosis Res Unit, Manchester, England

[2] Kings Coll London, Inst Psychiat Psychol & Neurosci, Inst Psychiat Psychol & Neurosci, London, England

[3] Univ Oxford, Dept Expt Psychol, Med Sci Div, Oxford, England

[4] Oxford Hlth NHS Fdn Trust, Oxford, England

[5] City Univ London, Sch Hlth & Psychol Sci, London, England

[6] Univ Glasgow, Sch Hlth & Wellbeing, Glasgow, Scotland

[7] East London NHS Fdn Trust, London, England

[8] UCL, Div Psychiat, London, England

[9] Northeast London NHS Fdn Trust, Res & Dev, Rainham, Essex, England

[10] Univ Michigan, Med Sch, Dept Psychiat, Ann Arbor, MI USA

[11] VA Ctr Clin Management Res, Ann Arbor, MI USA

[12] Univ New South Wales, Black Dog Inst, Sydney, Australia

[13] Univ Manchester, Manchester Ctr Hlth Econ, Sch Hlth Sci, Div Populat Hlth, Manchester, England

[14] McPin Fdn, 7-14 Great Dover St, London, England

[15] Univ Manchester, Div Psychol & Mental Hlth, Manchester, England

[16] Univ New South Wales, Ctr Big Data Res Hlth, Sydney, Australia

来源：

TRIALS | 2024年 / 25卷 / 01期

基金：

美国国家卫生研究院;

关键词：

Serious mental health problems; Suicide; Psychiatric admission; Psychosocial intervention; Adaptive trial design; Multi-arm; Multi-stage; Randomised controlled trial; ADMISSION; METAANALYSIS; PREVALENCE; VALIDITY; ILLNESS;

D O I：

10.1186/s13063-024-08293-5

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundPeople 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.MethodsA 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).DiscussionThere 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 registrationISRCTN33079589. Registered on June 20, 2022.

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页数：18