Cargando…
Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder
BACKGROUND: Bipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2007
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1797163/ https://www.ncbi.nlm.nih.gov/pubmed/17274807 http://dx.doi.org/10.1186/1471-244X-7-6 |
_version_ | 1782132300673187840 |
---|---|
author | Lobban, Fiona Gamble, Carol Kinderman, Peter Taylor, Lee Chandler, Claire Tyler, Elizabeth Peters, Sarah Pontin, Eleanor Sellwood, William Morriss, Richard K |
author_facet | Lobban, Fiona Gamble, Carol Kinderman, Peter Taylor, Lee Chandler, Claire Tyler, Elizabeth Peters, Sarah Pontin, Eleanor Sellwood, William Morriss, Richard K |
author_sort | Lobban, Fiona |
collection | PubMed |
description | BACKGROUND: Bipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS) interventions in ways that will enhance dissemination. METHODS AND DESIGN: This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs) in community mental health teams (CMHTs) to offer Enhanced Relapse Prevention (ERP) to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU). The main aims of the study are (1) to determine the acceptability of the intervention, training and outcome measures (2) to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3) to estimate the design effect of clustering for key outcome variables (4) to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. DISCUSSION: This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular cluster randomised controlled trials. |
format | Text |
id | pubmed-1797163 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2007 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-17971632007-02-14 Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder Lobban, Fiona Gamble, Carol Kinderman, Peter Taylor, Lee Chandler, Claire Tyler, Elizabeth Peters, Sarah Pontin, Eleanor Sellwood, William Morriss, Richard K BMC Psychiatry Study Protocol BACKGROUND: Bipolar Disorder (BD) is a common and severe form of mental illness characterised by repeated relapses of mania or depression. Pharmacotherapy is the main treatment currently offered, but this has only limited effectiveness. A recent Cochrane review has reported that adding psycho-social interventions that train people to recognise and manage the early warning signs of their relapses is effective in increasing time to recurrence, improving social functioning and in reducing hospitalisations. However, the review also highlights the difficulties in offering these interventions within standard mental health services due to the need for highly trained therapists and extensive input of time. There is a need to explore the potential for developing Early Warning Sign (EWS) interventions in ways that will enhance dissemination. METHODS AND DESIGN: This article describes a cluster-randomised trial to assess the feasibility of training care coordinators (CCs) in community mental health teams (CMHTs) to offer Enhanced Relapse Prevention (ERP) to people with Bipolar Disorder. CMHTs in the North West of England are randomised to either receive training in ERP and to offer this to their clients, or to continue to offer treatment as usual (TAU). The main aims of the study are (1) to determine the acceptability of the intervention, training and outcome measures (2) to assess the feasibility of the design as measured by rates of recruitment, retention, attendance and direct feedback from participants (3) to estimate the design effect of clustering for key outcome variables (4) to estimate the effect size of the impact of the intervention on outcome. In this paper we provide a rationale for the study design, briefly outline the ERP intervention, and describe in detail the study protocol. DISCUSSION: This information will be useful to researchers attempting to carry out similar feasibility assessments of clinical effectiveness trials and in particular cluster randomised controlled trials. BioMed Central 2007-02-02 /pmc/articles/PMC1797163/ /pubmed/17274807 http://dx.doi.org/10.1186/1471-244X-7-6 Text en Copyright © 2007 Lobban et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Study Protocol Lobban, Fiona Gamble, Carol Kinderman, Peter Taylor, Lee Chandler, Claire Tyler, Elizabeth Peters, Sarah Pontin, Eleanor Sellwood, William Morriss, Richard K Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
title | Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
title_full | Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
title_fullStr | Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
title_full_unstemmed | Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
title_short | Enhanced relapse prevention for bipolar disorder – ERP trial. A cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
title_sort | enhanced relapse prevention for bipolar disorder – erp trial. a cluster randomised controlled trial to assess the feasibility of training care coordinators to offer enhanced relapse prevention for bipolar disorder |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1797163/ https://www.ncbi.nlm.nih.gov/pubmed/17274807 http://dx.doi.org/10.1186/1471-244X-7-6 |
work_keys_str_mv | AT lobbanfiona enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT gamblecarol enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT kindermanpeter enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT taylorlee enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT chandlerclaire enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT tylerelizabeth enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT peterssarah enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT pontineleanor enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT sellwoodwilliam enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder AT morrissrichardk enhancedrelapsepreventionforbipolardisordererptrialaclusterrandomisedcontrolledtrialtoassessthefeasibilityoftrainingcarecoordinatorstoofferenhancedrelapsepreventionforbipolardisorder |