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; Sharon Anne Simpson; Nicole Cockayne; Gemma Shields; Ariane Beckley; Helen Beckwith; Maria Filippidou; Callum Glen; Stephanie Allan; Raj Hazzard; Eleanor Longden; Heather Peel; Mark Larsen; Sandra Bucci; Anthony P Morrison

doi:10.1186/s13063-024-08293-5

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, Sharon Anne Simpson, Nicole Cockayne, Gemma Shields, Ariane Beckley, Helen Beckwith, Maria Filippidou, Callum Glen, Stephanie Allan, Raj Hazzard, Eleanor LongdenHeather Peel, Mark Larsen, Sandra Bucci, Anthony P Morrison

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	460
Pages (from-to)	460
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08293-5
Publication status	Published - 6 Jul 2024

Keywords

Humans
Suicidal Ideation
Suicide Prevention
Randomized Controlled Trials as Topic
Psychosocial Intervention/methods
Mental Disorders/therapy
Cost-Benefit Analysis
Treatment Outcome
Multicenter Studies as Topic
Time Factors
Mental Health
Telemedicine
Cognitive Behavioral Therapy/methods
Mobile Applications
Crisis Intervention/methods

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Pyle, M., Loftus, L., Emsley, R., Freeman, D., Gillard, S., Gumley, A., Sierpatowska, J., Wood, L., O'Connor, R. C., Pfeiffer, P., Simpson, S. A., Cockayne, N., Shields, G., Beckley, A., Beckwith, H., Filippidou, M., Glen, C., Allan, S., Hazzard, R., ... Morrison, A. P. (2024). 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). Trials, 25(1), 460. Article 460. https://doi.org/10.1186/s13063-024-08293-5

Pyle, Melissa ; Loftus, Lucy ; Emsley, Richard et al. / 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). In: Trials. 2024 ; Vol. 25, No. 1. pp. 460.

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title = "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)",

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.",

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author = "Melissa Pyle and Lucy Loftus and Richard Emsley and Daniel Freeman and Steven Gillard and Andrew Gumley and Justyna Sierpatowska and Lisa Wood and O'Connor, {Rory C} and Paul Pfeiffer and Simpson, {Sharon Anne} and Nicole Cockayne and Gemma Shields and Ariane Beckley and Helen Beckwith and Maria Filippidou and Callum Glen and Stephanie Allan and Raj Hazzard and Eleanor Longden and Heather Peel and Mark Larsen and Sandra Bucci and Morrison, {Anthony P}",

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year = "2024",

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doi = "10.1186/s13063-024-08293-5",

language = "English",

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journal = "Trials",

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Pyle, M, Loftus, L, Emsley, R, Freeman, D, Gillard, S, Gumley, A, Sierpatowska, J, Wood, L, O'Connor, RC, Pfeiffer, P, Simpson, SA, Cockayne, N, Shields, G, Beckley, A, Beckwith, H, Filippidou, M, Glen, C, Allan, S, Hazzard, R, Longden, E, Peel, H, Larsen, M, Bucci, S & Morrison, AP 2024, '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)', Trials, vol. 25, no. 1, 460, pp. 460. https://doi.org/10.1186/s13063-024-08293-5

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). / Pyle, Melissa; Loftus, Lucy; Emsley, Richard et al.
In: Trials, Vol. 25, No. 1, 460, 06.07.2024, p. 460.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

T2 - Remote Approaches to Psychosocial Intervention Delivery (RAPID)

AU - Pyle, Melissa

AU - Loftus, Lucy

AU - Emsley, Richard

AU - Freeman, Daniel

AU - Gillard, Steven

AU - Gumley, Andrew

AU - Sierpatowska, Justyna

AU - Wood, Lisa

AU - O'Connor, Rory C

AU - Pfeiffer, Paul

AU - Simpson, Sharon Anne

AU - Cockayne, Nicole

AU - Shields, Gemma

AU - Beckley, Ariane

AU - Beckwith, Helen

AU - Filippidou, Maria

AU - Glen, Callum

AU - Allan, Stephanie

AU - Hazzard, Raj

AU - Longden, Eleanor

AU - Peel, Heather

AU - Larsen, Mark

AU - Bucci, Sandra

AU - Morrison, Anthony P

N1 - Publisher Copyright: © The Author(s) 2024.

PY - 2024/7/6

Y1 - 2024/7/6

N2 - 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.

AB - 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.

KW - Humans

KW - Suicidal Ideation

KW - Suicide Prevention

KW - Randomized Controlled Trials as Topic

KW - Psychosocial Intervention/methods

KW - Mental Disorders/therapy

KW - Cost-Benefit Analysis

KW - Treatment Outcome

KW - Multicenter Studies as Topic

KW - Time Factors

KW - Mental Health

KW - Telemedicine

KW - Cognitive Behavioral Therapy/methods

KW - Mobile Applications

KW - Crisis Intervention/methods

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DO - 10.1186/s13063-024-08293-5

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JF - Trials

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