Contact information
Type
Scientific
Primary contact
Dr Fiona Lobban
ORCID ID
Contact details
Department of Clinical Psychology
Ground Floor
The Whelan Building
The Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
+44 (0)151 794 5528
fiona.lobban@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TP165; G0301042
Study information
Scientific title
Acronym
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bipolar Disorder (Type I and II)
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
10/01/2005
Overall trial end date
09/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 people with bipolar disorder, 40 CCs, 10 CMHTs
Participant 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
Recruitment start date
10/01/2005
Recruitment end date
09/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Clinical Psychology
Liverpool
L69 3GB
United Kingdom
Sponsor information
Organisation
The University of Liverpool (UK)
Sponsor details
P.O. Box 147
Liverpool
L69 3BA
United Kingdom
+44 (0)151 794 2000
claire.chandler@liv.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0301042)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Mersey Care NHS Trust 2004/28 (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
4. 2011 multi-perspective qualitative study in http://www.ncbi.nlm.nih.gov/pubmed/22044486
Publication citations
-
Protocol
Lobban F, Gamble C, Kinderman P, Taylor L, Chandler C, Tyler E, Peters S, Pontin E, Sellwood W, Morriss RK, 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., BMC Psychiatry, 2007, 7, 6, doi: 10.1186/1471-244X-7-6.
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Qualitative investigation
Pontin E, Peters S, Lobban F, Rogers A, Morriss RK, Enhanced relapse prevention for bipolar disorder: a qualitative investigation of value perceived for service users and care coordinators., Implement Sci, 2009, 4, 4, doi: 10.1186/1748-5908-4-4.
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Results
Lobban F, Taylor L, Chandler C, Tyler E, Kinderman P, Kolamunnage-Dona R, Gamble C, Peters S, Pontin E, Sellwood W, Morriss RK, Enhanced relapse prevention for bipolar disorder by community mental health teams: cluster feasibility randomised trial., Br J Psychiatry, 2010, 196, 1, 59-63, doi: 10.1192/bjp.bp.109.065524.
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Peters S, Pontin E, Lobban F, Morriss R, Involving relatives in relapse prevention for bipolar disorder: a multi-perspective qualitative study of value and barriers., BMC Psychiatry, 2011, 11, 172, doi: 10.1186/1471-244X-11-172.