Condition category
Mental and Behavioural Disorders
Date applied
05/09/2005
Date assigned
07/10/2005
Last edited
10/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.liverpool.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0301042)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Additional files

Editorial Notes