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11 February 2012
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| [ Print-friendly version ] |
| Feasability study of Enhanced Relapse Prevention (ERP) delivered by Care Coordinators (CCs) to people with Bipolar Disorder (BD) - a cluster randomised controlled trial |
| ISRCTN | ISRCTN41352631 |
| ClinicalTrials.gov identifier | |
| Public title | Feasability study of Enhanced Relapse Prevention (ERP) delivered by Care Coordinators (CCs) to people with Bipolar Disorder (BD) - a cluster randomised controlled trial |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | TP165; G0301042 |
| Study hypothesis |
Aim:
To develop a brief Enhanced Relapse Prevention (ERP) for people with Bipolar Disorder which can be offered by Care Co-ordinators (CCs) in the NHS and to gather specific information required to inform the design of a large multi-site trial to test its effectiveness in comparison to treatment as usual. Objectives: 1. To devise a manual for brief Enhanced Relapse Prevention (ERP) 2. To refine a methodology to train (CCs) in ERP 3. To assess the effectiveness of the training package by assessing CC skills 4. To gain feedback form CCs receiving training in order to identify barriers and solutions in offering such training in a large trial 5. To calculate an estimate of the relationship of between to within cluster variance needed to design a cluster RCT for ERP 6. To compare outcome of patients receiving ERP and those receiving treatment as usual to estimate the effect size of the intervention 7. To estimate rates of recruitment and dropout for a large trial of this intervention 8. To gain feedback from people receiving the intervention in order to identify barriers and solutions to offering this intervention in a large trial |
| Lay summary | |
| Ethics approval | Added as of 30/07/2007: Ethical approval through Central Office for Research Ethics Committees (COREC) and Research & Development (R&D) approval at each Trust has been given. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Bipolar Disorder (Type I and II) |
| Participants - inclusion criteria |
1. Lifetime diagnosis of Bipolar Disorder (I or II)
2. Two or more relapses ever and at least one in the last year or two in the last 3 years 3. Currently in contact with healthcare professional attached to a CMHT 4. Working understanding of English language |
| Participants - exclusion criteria |
1. Substantial cognitive impairment, i.e. moderate/severe learning disability
2. Drug/alcohol abuse/dependence a primary diagnosis, i.e people who use drugs/alcohol are not excluded unless the severity of this would make them unable to engage with the intervention 3. No working understanding of the English language |
| Anticipated start date | 10/01/2005 |
| Anticipated end date | 09/01/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 120 people with bipolar disorder, 40 CCs, 10 CMHTs |
| Interventions |
ERP versus TAU
1. A training package for ERP delivered to CCs who are part of Community Mental Health Teams (CMHTs) and who have current active caseloads of people with BD. The training will include theoretical background and rationale for the approach, detailed analysis of the content of each session in the manual and videoed role play using trained actors. Written materials will accompany all aspects of training, and will take place over six 2-h sessions. 2. Following training, CCs will offer ERP to patients who have a diagnosis of BD. This involves patients and CCs working together to identify prodromal signs of manic and depressive relapse separately and developing and rehearsing an action plan for responding to such signs. As of 14/02/2007: Please note that the anticipated end date of this trial has been extended to 20/01/2007. |
| Primary outcome measure(s) |
1. The effectiveness of the training intervention with CCs assessed by training and CC ratings
2. An estimate of the effect size of the ERP intervention by CCs will be made by comparing patients receiving ERP with those receiving treatment as usual on: a. Time to recurrence to an episode of illness of sufficient severity to reach Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for major depressive, manic, or mixed episode, based on the Structured Clinical Interview for Depression (SCID) interview b. Assessment of coping using the Coping with Manic and Depressive Prodromes checklist c. The Client Service Receipt Schedule (CSRI) to estimate the use of primary, inpatient, outpatient, day patient, community and emergency services The feasibility will be assessed using quantitative and qualitative data. Quantitative data: 1. Recruitment rates of CMHTs: proportion of teams approached who agreed to take part 2. Attendance rates: the number of training and supervision sessions attended by each care coordinator 3. Care coordinator feedback ratings of training and supervision 4. Service user recruitment rates: number of service users recruited within each group - ERP and TAU 5. Service user retention rates: number of service users that completed follow-up at each point 6. Number of relatives taking part (ERP only) Qualitative data: 1. Interview feedback from care coordinators (ERP and TAU) 2. Feedback from service users and relatives (ERP only) identifying barriers to the intervention. An estimate of the effect size of the intervention will be made using time from baseline to recurrence of an episode of major depression , hypomania, mania, or mixed, satisfying DSM-IV criteria, as the main outcome. All outcomes will be reported allowing for design effect. |
| Secondary outcome measure(s) |
1. Longitudinal analysis of symptom severity using the Longitudinal Interval Follow-up Evaluation (LIFE-II) modified to DSM criteria
2. An estimate of recruitment and drop-out rates 3. Qualitative interviews to gather detailed information from CCs of their experience of training and offering ERP, and from patients with BD and their friends/relatives of their experience of therapy |
| Sources of funding |
1. Medical Research Council (MRC) (UK) (ref: G0301042)
2. Mersey Care NHS Trust 2004/28 (UK) |
| Trial website | |
| Publications |
1. 2007 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17274807
2. 2009 qualitative investigation in http://www.ncbi.nlm.nih.gov/pubmed/19203373 3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20044662 |
| Contact name | Dr Fiona Lobban |
| Address |
Department of Clinical Psychology
Ground Floor The Whelan Building The Quadrangle Brownlow Hill |
| City/town | Liverpool |
| Zip/Postcode | L69 3GB |
| Country | United Kingdom |
| Tel | +44 (0)151 794 5528 |
| Fax | +44 (0)151 794 5537 |
| fiona.lobban@liv.ac.uk | |
| Sponsor | The University of Liverpool (UK) |
| Address | P.O. Box 147 |
| City/town | Liverpool |
| Zip/Postcode | L69 3BA |
| Country | United Kingdom |
| Tel | +44 (0)151 794 2000 |
| claire.chandler@liv.ac.uk | |
| Sponsor website: | http://www.liverpool.ac.uk |
| Date applied | 05/09/2005 |
| Last edited | 16/04/2010 |
| Date ISRCTN assigned | 07/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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