A web-based Enhanced Relapse Prevention (ERP-online) intervention for bipolar disorder
| ISRCTN | ISRCTN56908625 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56908625 |
| Secondary identifying numbers | 13957 |
- Submission date
- 26/03/2013
- Registration date
- 26/03/2013
- Last edited
- 26/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 September 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
Contact information
Scientific
Spectrum Centre for Mental Health Research
Lancaster University
Lancaster
LA1 4YG
United Kingdom
| f.lobban@lancaster.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at http://www.erponline.co.uk/participant_information |
| Scientific title | A pilot study to assess the feasibility of a web-based intervention for prevention of relapse in bipolar disorder (ERP-Online) |
| Study acronym | ERP-online |
| Study hypothesis | ERP Online will be feasible, acceptable and effective for individuals with bipolar disorder. |
| Ethics approval(s) | Lancaster NHS Research Ethics Committee and Lancaster University Research Ethics Committee, First MREC approval date 14/08/2012, ref: 12/NW/0594 |
| 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 |
| Primary outcome measure | From 10/10/2017: Feasibility and acceptability (recruitment, retention, data completion, ERPonline website usage, adverse events, participant feedback). Prior to 10/10/2017: Weeks well; Timepoint(s): 12, 24, 36, 48 weeks |
| Secondary outcome measures | From 10/10/2017: Estimates of impact on participant outcomes [weeks well (time spent euthymic), relapse, depression, mania, quality of life, functioning, personal recovery) and potential mechanisms of change (medication adherence, illness perceptions, early warning signs monitoring)]. Prior to 10/10/2017: No secondary outcome measures. |
| Overall study start date | 01/10/2012 |
| Overall study end date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 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 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 | 12/04/2013 |
| Recruitment end date | 30/04/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LA1 4YG
United Kingdom
Sponsor information
University/education
Clinical Anatomy Learning Centre
Lancaster
LA1 4YT
England
United Kingdom
| Website | http://www.lancs.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04f2nsd36 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Fiona Lobban, email: f.lobban@lancaster.ac.uk. The type of data available is anonymised quantitative datasets only, as participants gave consent for publication of anonymised data. Any requests will be reviewed by the ERPonline team and independent Trial Steering Committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/03/2017 | Yes | No |
Editorial Notes
26/10/2017: The trial start/end dates and the recruitment start/end date have been clarified and corrected. The PI confirmed the following: “The study started on 01/10/2012 (trial start date), the consent of first person in the trial was 12/04/2013 (recruitment start date), the last person consented was on 30/04/2014 (recruitment end date), the study ended on 30/09/2015 – (trial end date).”
17/10/2017: Internal review.
10/10/2017: Outcomes and IPD statement clarified. The PI explained the following: "We want to highlight that recruitment in the sense of allowing participants to give their consent to take part did not open until all NHS approvals and registration, which happened in tandem. This is a feasibility trial and as such the primary outcomes were feasibility and acceptability, as stated in the Plain English summary. Quantitative outcome data was examined to inform the selection of measures sensitive to change, and to identify potential positive and negative impacts that should be further tested in a large scale definitive trial. This study was not powered to test for a statistically significant impact, and as such we did not specify a primary clinical outcome. Therefore, we wish to clarify that all clinical process and outcome measures are secondary outcomes, consistent with the published protocol paper. At this stage we are not intending to run a main trial of the same ERPonline intervention, but are reviewing what we have learnt from this study to inform our next steps.”
28/03/2017: Publication reference added.
07/05/2013: The target number of participants was changed from 80 to 125.
