Evidence map›Paper›PMID 38971788›Full record

ArticleTrials2024

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).

Melissa Pyle, Lucy Loftus, Richard Emsley, Daniel Freeman, Steven Gillard, Andrew Gumley, Justyna Sierpatowska, Lisa Wood, Rory C O'Connor, Paul Pfeiffer and 14 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Melissa PyleThe Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Lucy LoftusThe Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Richard EmsleyDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Daniel FreemanDepartment of Experimental Psychology, Medical Sciences Division, University of Oxford, Oxford, UK.
Steven GillardSchool of Health & Psychological Sciences, City, University of London, London, UK.
Andrew GumleySchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Justyna SierpatowskaEast London NHS Foundation Trust, London, UK.
Lisa WoodDivision of Psychiatry, University College London, London, UK.
Rory C O'ConnorSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Paul PfeifferDepartment of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, USA.
Sharon Anne SimpsonSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Nicole CockayneBlack Dog Institute, University of New South Wales, Sydney, Australia.
Gemma ShieldsManchester Centre for Health Economics, Division of Population Health, School of Health Sciences, University of Manchester, Manchester, UK.
Ariane BeckleyDepartment of Experimental Psychology, Medical Sciences Division, University of Oxford, Oxford, UK.
Helen BeckwithDepartment of Experimental Psychology, Medical Sciences Division, University of Oxford, Oxford, UK.
Maria FilippidouEast London NHS Foundation Trust, London, UK.
Callum GlenDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.
Stephanie AllanSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Raj HazzardMcPin Foundation, 7-14 Great Dover Street, London, UK.
Eleanor LongdenThe Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Heather PeelThe Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.
Mark LarsenBlack Dog Institute, University of New South Wales, Sydney, Australia.
Sandra BucciDivision of Psychology and Mental Health, University of Manchester, Manchester, UK.
Anthony P MorrisonThe Psychosis Research Unit, Department of Psychology, Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. anthony.p.morrison@manchester.ac.uk.ORCID http://orcid.org/0000-0002-4389-2091

Funding

Health Technology Assessment Programme NIHR132690
6 · The paper itself

Abstract

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). 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 registrationISRCTN33079589. Registered on June 20, 2022.

Indexed as

Cost-Benefit AnalysisMental DisordersPsychosocial InterventionRandomized Controlled Trials as TopicSuicidal IdeationSuicide PreventionAdaptive Clinical Trials as TopicCognitive Behavioral TherapyCrisis InterventionHumansMental HealthMobile ApplicationsMulticenter Studies as TopicTelemedicineTime FactorsTreatment OutcomeAdaptive trial designMulti-armMulti-stagePsychiatric admissionPsychosocial interventionRandomised controlled trialSerious mental health problemsSuicide

Identifiers

PMID38971788
PMCPMC11227697

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.