Condition category
Mental and Behavioural Disorders
Date applied
26/03/2013
Date assigned
26/03/2013
Last edited
19/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Individuals with bipolar disorder (BD) typically experience periods of extreme high and low mood (mania and depression). BD is treated with medication, yet many people continue to experience relapses. Enhanced Relapse Prevention (ERP) is a psychological approach developed by members of our research team and found effective in reducing relapse and improving functioning in BD. Limited NHS resources restrict the availability of face-to-face ERP. This study will translate ERP into an interactive web resource (ERP online), which has the potential to increase accessibility. The main purpose of this study is to assess the feasibility and acceptability of ERP online.

Who can participate?
We will ask 125 individuals with BD (who have had 3 relapses in their lifetime, with 1 falling in the past 2 years and access to the internet) to take part.

What does the study involve?
Half of the individuals with bipolar disorder will use ERP online for 12 months alongside current treatment, and we will compare their outcome with the other half, who will receive current treatment only. Individuals that experience crisis may access support services in their usual way via their care team/GP. National crisis support services will also be signposted on ERP online.
Outcome measures include observer-rated mood (assessed using telephone interviews at 12 week intervals for a total of 48 weeks) and self-report questionnaires on functioning, quality of life, medication adherence and use of health services (delivered online every 24 weeks for a total of 48 weeks). Twenty participants who have used ERP online will be invited to an interview to provide feedback on whether ERP online is an acceptable intervention they want to use. We may also interview friends or health professionals who participants have chosen to involve in the intervention as a way of understanding their experiences of this process.

What are the possible benefits and risks of participating?
Participants who are allocated to the intervention arm of the trial will receive ERP Online which we hope will be helpful in reducing relapse and improving functioning and quality of life for individuals with bipolar disorder. In addition to this, all participants will have regular appointments with the research team to talk about their own mood experiences. In our experience of conducting similar research, participants valued sharing their personal experiences. All individuals taking part in this study will be making a valuable contribution to understanding the experiences of bipolar disorder and this knowledge will then be used to help design specific and appropriate treatment interventions for people with bipolar disorder. Participants will be paid £10 in vouchers (Amazon.co.uk) per assessment as a token of appreciation for their time and effort (at the beginning of the study and again at 12, 24, 36 and 48 weeks).
It is possible that talking about personal experiences may cause distress. The researcher will be sensitive to this. Participants will have the opportunity to discuss any concerns at the end of the assessments and will be free to stop the process at any point. Following each assessment appointment the researcher will also offer the opportunity for a follow-up phone call the next day to ensure participants are feeling okay and to check whether there are any issues relating to the research which the participant wishes to discuss.

Where is the study run from?
The project is led by the Spectrum Centre for Mental Health Research at Lancaster University in collaboration with Cumbria Partnership NHS Foundation Trust and the University of Nottingham.

When is the study starting and how long is it expected to run for?
The study started in October 2012 and will be completed by October 2015.

Who is funding the study?
This study is funded by the National Institute for Health Research and a collaboration between Lancaster University, Cumbria Partnership NHS Foundation Trust, and the University of Nottingham.

Who is the main contact?
Adam Sawczuk, ERP Research Assistant
a.sawczuk@lancaster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fiona Lobban

ORCID ID

Contact details

Spectrum Centre for Mental Health Research
Lancaster University
Lancaster
LA1 4YG
United Kingdom
-
f.lobban@lancaster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

13957

Study information

Scientific title

A pilot study to assess the feasibility of a web-based intervention for prevention of relapse in bipolar disorder (ERP-Online)

Acronym

ERP-online

Study hypothesis

ERP Online will be feasible, acceptable and effective for individuals with bipolar disorder.

Ethics approval

Lancaster NHS Research Ethics Committee and Lancaster University Research Ethics Committee, First MREC approval date 14/08/2012, ref: 12/NW/0594

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at http://www.erponline.co.uk/participant_information

Condition

Topic: Mental Health Research Network; Subtopic: Bipolar affective disorder; Disease: Bipolar affective disorder

Intervention

1. ERP Online, Web-based Psychological Intervention
2. Current treatment only

Follow Up Length: 12 month(s)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Weeks well; Timepoint(s): 12, 24, 36, 48 weeks

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2012

Overall trial end date

01/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female, over 18 years of age
2. Access to a computer and the internet. ERP-online will only be accessible via the internet, so computer and internet access is necessary. However, it is up to individual participants where they wish to access the intervention, so we have not stipulated that they must own a computer, in order to allow those who access computers in public areas or at the homes of friends/family to take part.
3. Meet SCID research diagnostic criteria for bipolar disorder type 1 or 2. ERP in face-to-face form has been evaluated among individuals with this diagnosis, and it was specifically developed to help service users to identify the triggers and early warning signs of mania/depression (symptoms of bipolar disorder), and how to manage these.
4. Have had 3 relapses in their lifetime, with 1 falling in the preceding 2 years. This is to ensure we have a sample considered high risk for relapse for which this kind of intervention is most appropriate.
5. Unfortunately our budget is not sufficient to cover the costs of a translating the online intervention content and some of the questionnaire measures used in this study are not validated in other languages. For this reason we have made one of our inclusion criteria the ability to understand spoken and written English.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 125; UK Sample Size: 125; Description: The sample size may increase if there is a high rate of attrition.

Participant exclusion criteria

1. An organic cause for the disorder
2. Primary diagnosis of alcohol or substance misuse
3. Unable/unwilling to give informed consent
4. In current episode (or in episode within previous 4 weeks) this is because the intervention focuses on the identification and management of early warning signs of relapse and therefore is not intended for those currently in episode who would benefit from a different kind of approach.
5 Currently taking part in another intervention study (or follow-up period). This is to reduce burden of research participation on any one individual and to control for the effects of involvement in another intervention study at the same time.
6. Currently being treated under a section of the mental health act.

Recruitment start date

01/10/2012

Recruitment end date

01/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lancaster University
Lancaster
LA1 4YG
United Kingdom

Sponsor information

Organisation

Lancaster University (UK)

Sponsor details

Clinical Anatomy Learning Centre
Lancaster
LA1 4YT
United Kingdom

Sponsor type

University/education

Website

http://www.lancs.ac.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-10001

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

Publication citations

Additional files

Editorial Notes

07/05/2013: the target number of participants was changed from 80 to 125.