Aggression following traumatic brain injury: effectiveness of Risperidone (AFTER): study protocol for a feasibility randomised controlled trial

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Deb, S., Leeson, V., Aimola, L., Bodani, M., Li, L., Weaver, T., Sharp, D. and Crawford, M. 2018. Aggression following traumatic brain injury: effectiveness of Risperidone (AFTER): study protocol for a feasibility randomised controlled trial. Trials. 19. https://doi.org/10.1186/s13063-018-2601-z
TypeArticle
TitleAggression following traumatic brain injury: effectiveness of Risperidone (AFTER): study protocol for a feasibility randomised controlled trial
AuthorsDeb, S., Leeson, V., Aimola, L., Bodani, M., Li, L., Weaver, T., Sharp, D. and Crawford, M.
Abstract

Background: Traumatic brain injury (TBI) is a major public health concern and many people develop long-lasting physical and neuropsychiatric consequences following a TBI. Despite the emphasis on physical rehabilitation, it is the emotional and behavioural consequences that have greater impact on people with TBI and their families. One such problem behaviour is aggression which can be directed towards others, towards property or towards the self.Aggression is reported to be common after TBI (37–71%) and causes major stress for patients and their families.Both drug and non-drug interventions are used to manage this challenging behaviour, but the evidence-base for these interventions is poor and no drugs are currently licensed for the treatment of aggression following TBI. The most commonly used drugs for this purpose are antipsychotics, particularly second-generation drugs such as risperidone. Despite this widespread use, randomised controlled trials (RCTs) of antipsychotic drugs, including risperidone, have not been conducted. We have, therefore, set out to test the feasibility of conducting an RCT of this drug for people who have aggressive behaviour following TBI.
Methods/design: We will examine the feasibility of conducting a placebo-controlled, double-blind RCT of risperidone for the management of aggression in adults with TBI and also assess participants’ views about their experience of taking part in the study. We will randomise 50 TBI patients from secondary care services in four centres in London and Kent to up to 4 mg of risperidone orally or an inert placebo and follow them up 12 weeks later. Participants will be randomised to active or control treatment in a 1:1 ratio via an external and remote web-based randomisation service. Participants will be assessed at baseline and 12-week follow-up using a battery of assessment scales to measure changes in aggressive behaviour (MOAS, IRQ) as well as global functioning (GOS-E, CGI), quality of life (EQ-5D-5L, SF-12) and mental health (HADS). We will also assess the adverse effect profile with a standard scale (UKU) and collect available data from medical records on blood tests (serum glucose/HbA1c, lipid profile, prolactin), and check body weight and blood pressure. In addition completion of the MOAS and a check for any new or worsening side-effect will be completed weekly and used by the prescribing clinician to determine continuing dosage. Family carers’ well being will be assessed with CWSQ. Service use will be recorded using CSRI. A process evaluation will be carried out at theend of the trial using both qualitative and quantitative methodology.
Discussion: Aggressive behaviour causes immense distress among some people with TBI and their families. By examining the feasibility of a double-blind, placebo-controlled RCT, we aim to discover whether this approach can successfully be used to test the effects of risperidone for the treatment of aggressive behaviour among people with aggression following TBI and improve the evidence base for the treatment of these symptoms. Our criteria for demonstrating success of the feasibility study are: (1) recruitment of at least 80% of the study sample, (2) uptake of intervention by at least 80% of participants in the active arm of the trial and (3) completion of follow-up interviews at 12 weeks by at least 75% of the study participants.

KeywordsTraumatic brain injury ; Aggression; Pharmacological intervention; Risperidone; Feasibility; RCT
PublisherBMC
JournalTrials
ISSN1745-6215
Publication dates
Online21 Jun 2018
Print01 Dec 2018
Publication process dates
Deposited03 Jan 2019
Accepted19 Mar 2018
Output statusPublished
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© The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Article number = 325

Digital Object Identifier (DOI)https://doi.org/10.1186/s13063-018-2601-z
Web of Science identifierWOS:000435865800001
LanguageEnglish
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Völlm, B., Edworthy, R., Huband, N., Talbot, E., Majid, S., Holley, J., Furtado, V., Weaver, T., McDonald, R. and Duggan, C. 2018. Characteristics and pathways of long-stay patients in high and medium secure settings in England; a secondary publication from a large mixed-methods study. Frontiers in Psychiatry. 9. https://doi.org/10.3389/fpsyt.2018.00140
Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol
Johnson, S., Mason, O., Osborn, D., Milton, A., Henderson, C., Marston, L., Ambler, G., Hunter, R., Pilling, S., Morant, N., Gray, R., Weaver, T., Nolan, F. and Lloyd-Evans, B. 2017. Randomised controlled trial of the clinical and cost-effectiveness of a peer-delivered self-management intervention to prevent relapse in crisis resolution team users: study protocol. BMJ Open. 7 (10). https://doi.org/10.1136/bmjopen-2016-015665
Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme
Day, C., Briskman, J., Crawford, M., Harris, L., McCrone, P., McMurran, M., Moran, P., Morgan, L., Scott, S., Stahl, D., Ramchandani, P. and Weaver, T. 2017. Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme. Contemporary Clinical Trials Communications. 8, pp. 67-74. https://doi.org/10.1016/j.conctc.2017.08.002
A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial
Johnson, S., Rains, L., Marwaha, S., Strang, J., Craig, T., Weaver, T., McCrone, P., King, M., Fowler, D., Pilling, S., Marston, L., Omar, R., Craig, M. and Hinton, M. 2016. A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial. Trials. 17 (1). https://doi.org/10.1186/s13063-016-1620-x
Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial
Lingford-Hughes, A., Patel, Y., Bowden-Jones, O., Crawford, M., Dargan, P., Gordon, F., Parrott, S., Weaver, T. and Wood, D. 2016. Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial. Trials. 17. https://doi.org/10.1186/s13063-016-1593-9
Mind how you cross the gap! Outcomes for young people who failed to make the transition from child to adult services: the TRACK study
Islam, Z., Ford, T., Kramer, T., Paul, M., Parsons, H., Harley, K., Weaver, T., McLaren, S. and Singh, S. 2016. Mind how you cross the gap! Outcomes for young people who failed to make the transition from child to adult services: the TRACK study. BJPsych Bulletin. 40 (3), pp. 142-148. https://doi.org/10.1192/pb.bp.115.050690
An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence
Rafia, R., Dodd, P., Brennan, A., Meier, P., Hope, V., Ncube, F., Byford, S., Tie, H., Metrebian, N., Hellier, J., Weaver, T. and Strang, J. 2016. An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence. Addiction. 111 (9), pp. 1616-1627. https://doi.org/10.1111/add.13385
Hearing voices simulation: Process and outcomes of training
Patterson, S., Goulter, N. and Weaver, T. 2014. Hearing voices simulation: Process and outcomes of training. Journal of Mental Health Training, Education and Practice. 9 (1), pp. 46-58. https://doi.org/10.1108/JMHTEP-01-2013-0003
Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial
Weaver, T., Metrebian, N., Hellier, J., Pilling, S., Charles, V., Little, N., Poovendran, D., Mitcheson, L., Ryan, F., Bowden-Jones, O., Dunn, J., Glasper, A., Finch, E. and Strang, J. 2014. Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial. The Lancet. 384 (9938), pp. 153-163. https://doi.org/10.1016/S0140-6736(14)60196-3
Activity and views of service users involved in mental health research: UK survey
Patterson, S., Trite, J. and Weaver, T. 2014. Activity and views of service users involved in mental health research: UK survey. The British Journal of Psychiatry. 205 (1), pp. 68-75. https://doi.org/10.1192/bjp.bp.113.128637
Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network
Borschmann, R., Patterson, S., Poovendran, D., Wilson, D. and Weaver, T. 2014. Influences on recruitment to randomised controlled trials in mental health settings in England: a national cross-sectional survey of researchers working for the Mental Health Research Network. BMC Medical Research Methodology. 14 (1), p. 23. https://doi.org/10.1186/1471-2288-14-23
Monitoring and management of metabolic abnormalities: mixed-method evaluation of a successful intervention
Wilson, E., Randall, C., Patterson, S., Emmerson, B., Moudgil, V. and Weaver, T. 2014. Monitoring and management of metabolic abnormalities: mixed-method evaluation of a successful intervention. Australasian Psychiatry. 22 (3), pp. 248-253. https://doi.org/10.1177/1039856214529000
The effect of organisational resources and eligibility issues on transition from child and adolescent to adult mental health services
Belling, R., McLaren, S., Paul, M., Ford, T., Kramer, T., Weaver, T., Hovish, K., Islam, Z., White, S. and Singh, S. 2014. The effect of organisational resources and eligibility issues on transition from child and adolescent to adult mental health services. Journal of Health Services Research & Policy. 19 (3), pp. 169-176. https://doi.org/10.1177/1355819614527439
Multi-method Evaluation of the Management, Organisation and Staffing (MEMOS) in high security treatment services for people with Dangerous and Severe Personality Disorder (DSPD)
Trebilcock, J. and Weaver, T. 2010. Multi-method Evaluation of the Management, Organisation and Staffing (MEMOS) in high security treatment services for people with Dangerous and Severe Personality Disorder (DSPD). Personality Disorder Team.
Everybody knows that the prisoner is going nowhere: Parole Board members’ views about dangerous and severe personality disorder in England and Wales
Trebilcock, J. and Weaver, T. 2012. Everybody knows that the prisoner is going nowhere: Parole Board members’ views about dangerous and severe personality disorder in England and Wales. International Journal of Criminology and Sociology. 1, pp. 141-150. https://doi.org/10.6000/1929-4409.2012.01.14
‘Talking a different language’: an exploration of the influence of organizational cultures and working practices on transition from child to adult mental health services
McLaren, S., Belling, R., Paul, M., Ford, T., Kramer, T., Weaver, T., Hovish, K., Islam, Z., White, S. and Singh, S. 2013. ‘Talking a different language’: an exploration of the influence of organizational cultures and working practices on transition from child to adult mental health services. BMC Health Services Research. 13. https://doi.org/10.1186/1472-6963-13-254
The commissioning and provision of advocacy for problem drug users in English DATS; a cross sectional survey
Cargill, T., Weaver, T. and Patterson, S. 2012. The commissioning and provision of advocacy for problem drug users in English DATS; a cross sectional survey. Drugs: Education, Prevention, and Policy. 19 (2), pp. 163-170. https://doi.org/10.3109/09687637.2011.609204
Changing legal characteristics of dangerous and severe personality disorder (DSPD) patients and prisoners
Trebilcock, J. and Weaver, T. 2012. Changing legal characteristics of dangerous and severe personality disorder (DSPD) patients and prisoners. The Journal of Forensic Psychiatry & Psychology. 23 (2), pp. 237-243. https://doi.org/10.1080/14789949.2012.668212
‘It doesn't have to be treatable’: Mental Health Review Tribunal (MHRT) members’ views about Dangerous and Severe Personality Disorder (DSPD)
Trebilcock, J. and Weaver, T. 2012. ‘It doesn't have to be treatable’: Mental Health Review Tribunal (MHRT) members’ views about Dangerous and Severe Personality Disorder (DSPD). The Journal of Forensic Psychiatry & Psychology. 23 (2), pp. 244-260. https://doi.org/10.1080/14789949.2012.668208
Residents’ perceptions of water quality improvements following remediation work in the Pymme’s Brook catchment, north London, UK
Faulkner, H., Green, A., Pellaumail, K. and Weaver, T. 2001. Residents’ perceptions of water quality improvements following remediation work in the Pymme’s Brook catchment, north London, UK. Journal of Environmental Management. 62 (3), pp. 239-254. https://doi.org/10.1006/jema.2001.0435
Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study
Singh, S., Paul, M., Ford, T., Kramer, T., Weaver, T., McLaren, S., Hovish, K., Islam, Z., Belling, R. and White, S. 2010. Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study. The British Journal of Psychiatry. 197 (4), pp. 305-312. https://doi.org/10.1192/bjp.bp.109.075135
The Bentham unit: a pilot remand and assessment service for male mentally disordered remand prisoners. II: Report of an independent evaluation
Weaver, T., Taylor, F., Cunningham, B. and Maden, A. 1997. The Bentham unit: a pilot remand and assessment service for male mentally disordered remand prisoners. II: Report of an independent evaluation. The British Journal of Psychiatry. 170 (5), pp. 462-466. https://doi.org/10.1192/bjp.170.5.462