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

Article

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
PublisherBioMed Central (BMC)
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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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
Selecting outcome measures in mental health: the views of service users
Crawford, M.J., Robotham, D., Thana, L., Patterson, S., Weaver, T., Barber, R., Wykes, T. and Rose, D. 2011. Selecting outcome measures in mental health: the views of service users. Journal of Mental Health. 20 (4), pp. 336-346. https://doi.org/10.3109/09638237.2011.577114
Siblings of young people with Duchenne muscular dystrophy -- a qualitative study of impact and coping
Read, J., Kinali, M., Muntoni, F., Weaver, T. and Garralda, E. 2011. Siblings of young people with Duchenne muscular dystrophy -- a qualitative study of impact and coping. European Journal of Paediatric Neurology. 15 (1), pp. 21-28. https://doi.org/10.1016/j.ejpn.2010.07.006
Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study
Singh, S.P., 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
Drug service user groups: only a partial solution to the problem of developing user involvement
Patterson, S., Weaver, T. and Crawford, M. 2010. Drug service user groups: only a partial solution to the problem of developing user involvement. Drugs: Education, Prevention, and Policy. 17 (1), pp. 84-97. https://doi.org/10.3109/09687630802225495
The prevalence of personality disorder, its comorbidity with mental state disorders, and its clinical significance in community mental health teams
Newton-Howes, G., Tyrer, P., Anagnostakis, K., Cooper, S., Bowden-Jones, O. and Weaver, T. 2010. The prevalence of personality disorder, its comorbidity with mental state disorders, and its clinical significance in community mental health teams. Social Psychiatry and Psychiatric Epidemiology. 45 (4), pp. 453-460. https://doi.org/10.1007/s00127-009-0084-7
A qualitative study of illicit and non-prescribed drug use amongst people with psychotic disorders
Charles, V. and Weaver, T. 2010. A qualitative study of illicit and non-prescribed drug use amongst people with psychotic disorders. Journal of Mental Health. 19 (1), pp. 99-106. https://doi.org/10.3109/09638230802523039
Child involvement in the paediatric consultation: a qualitative study of children and carers' views
Taylor, S., Haase-Casanovas, S., Weaver, T., Kidd, J. and Garralda, E.M. 2010. Child involvement in the paediatric consultation: a qualitative study of children and carers' views. Child: Care, Health & Development. 36 (5), pp. 678-685. https://doi.org/10.1111/j.1365-2214.2010.01076.x
Delusions and qualitative confusions: a dialogic collaborative exploration
Patterson, S., Hart, J. and Weaver, T. 2010. Delusions and qualitative confusions: a dialogic collaborative exploration. Qualitative Health Research. 20 (7), pp. 1008-1018. https://doi.org/10.1177/1049732310363805
Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used
Pope, A., Adams, C., Paton, C., Weaver, T. and Barnes, T.R.E. 2010. Assessment of adverse effects in clinical studies of antipsychotic medication: survey of methods used. The British Journal of Psychiatry. 197 (1), pp. 67-72. https://doi.org/10.1192/bjp.bp.109.070961
User involvement in efforts to improve the quality of drug misuse services in England: a national survey
Patterson, S., Weaver, T., Agath, K., Rutter, D., Albert, E. and Crawford, M. 2009. User involvement in efforts to improve the quality of drug misuse services in England: a national survey. Drugs: Education, Prevention, and Policy. 16 (4), pp. 364-377. https://doi.org/10.1080/09687630802061544
Dedicated personality disorder services: a qualitative analysis of service structure and treatment process
Price, K., Gillespie, S., Rutter, D., Dhillon, K., Gibson, S., Faulkner, A., Weaver, T. and Crawford, M.J. 2009. Dedicated personality disorder services: a qualitative analysis of service structure and treatment process. Journal of Mental Health. 18 (6), pp. 467-475. https://doi.org/10.3109/09638230902968191
'They can't solve the problem without us': a qualitative study of stakeholder perspectives on user involvement in drug treatment services in England
Patterson, S., Weaver, T., Agath, K., Albert, E., Rhodes, T., Rutter, D. and Crawford, M. 2009. 'They can't solve the problem without us': a qualitative study of stakeholder perspectives on user involvement in drug treatment services in England. Health and Social Care in the Community. 17 (1), pp. 54-62. https://doi.org/10.1111/j.1365-2524.2008.00797.x
Transitions of care from child and adolescent mental health services to adult mental health services (TRACK study): a study of protocols in Greater London
Singh, S., Paul, M., Ford, T., Kramer, T. and Weaver, T. 2008. Transitions of care from child and adolescent mental health services to adult mental health services (TRACK study): a study of protocols in Greater London. BMC Health Services Research. 8 (1), pp. 1-7. https://doi.org/10.1186/1472-6963-8-135
Attitudes of staff towards patients with personality disorder in community mental health teams
Newton-Howes, G., Weaver, T. and Tyrer, P. 2008. Attitudes of staff towards patients with personality disorder in community mental health teams. Australian & New Zealand Journal of Psychiatry. 42 (7), pp. 572-577. https://doi.org/10.1080/00048670802119739
Social functioning of patients with personality disorder in secondary care
Newton-Howes, G., Tyrer, P. and Weaver, T. 2008. Social functioning of patients with personality disorder in secondary care. Psychiatric Services. 59 (9), pp. 1033-1037. https://doi.org/10.1176/ps.2008.59.9.1033
Dedicated community-based services for adults with personality disorder: Delphi study
Crawford, M.J., Price, K., Rutter, D., Moran, P., Tyrer, P., Bateman, A., Fonagy, P. and Weaver, T. 2008. Dedicated community-based services for adults with personality disorder: Delphi study. The British Journal of Psychiatry. 193 (4), pp. 342-343. https://doi.org/10.1192/bjp.bp.107.043042
Qualitative investigation of the mental health of migrants from former Yugoslavia: implications for epidemiological research
Djuretic, T., Crawford, M. and Weaver, T. 2007. Qualitative investigation of the mental health of migrants from former Yugoslavia: implications for epidemiological research. Journal of Mental Health. 16 (6), pp. 743-755. https://doi.org/10.1080/09638230701496394
Prevalence of personality disorder in alcohol and drug services and associated comorbidity
Bowden-Jones, O., Iqbal, M., Tyrer, P., Seivewright, N., Cooper, S., Judd, A., Weaver, T. and the COSMIC study team 2004. Prevalence of personality disorder in alcohol and drug services and associated comorbidity. Addiction. 99 (10), pp. 1306-1314. https://doi.org/10.1111/j.1360-0443.2004.00813.x
User involvement in the planning and delivery of mental health services: a cross-sectional survey of service users and providers
Crawford, M.J., Aldridge, T., Bhui, K., Rutter, D., Manley, C., Weaver, T., Tyrer, P. and Fulop, N. 2003. User involvement in the planning and delivery of mental health services: a cross-sectional survey of service users and providers. Acta Psychiatrica Scandinavica. 107 (6), pp. 410-414. https://doi.org/10.1034/j.1600-0447.2003.00049.x
Assessing the value of assertive outreach: Qualitative study of process and outcome generation in the UK700 trial
Weaver, T., Tyrer, P., Ritchie, J. and Renton, A. 2003. Assessing the value of assertive outreach: Qualitative study of process and outcome generation in the UK700 trial. The British Journal of Psychiatry. 183 (5), pp. 437-435. https://doi.org/10.1192/bjp.183.5.437
Results of a screening survey for co-morbid substance misuse amongst patients in treatment for psychotic disorders: prevalence and service needs in an inner London borough
Weaver, T., Rutter, D., Madden, P., Ward, J., Stimson, G. and Renton, A. 2001. Results of a screening survey for co-morbid substance misuse amongst patients in treatment for psychotic disorders: prevalence and service needs in an inner London borough. Social Psychiatry and Psychiatric Epidemiology. 36 (8), pp. 399-406. https://doi.org/10.1007/s001270170030
The prevalence and management of co-morbid substance misuse and mental illness: results of a screening survey in substance misuse and mental health treatment populations
Weaver, T., Hickman, M., Rutter, D., Ward, J., Stimson, G. and Renton, A. 2001. The prevalence and management of co-morbid substance misuse and mental illness: results of a screening survey in substance misuse and mental health treatment populations. Drug and Alcohol Review. 20 (4), pp. 407-416. https://doi.org/10.1080/09595230120092724
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
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