Participant Information

 
We would like to invite you to take part in this research study to evaluate a web-based intervention to prevent relapse in bipolar disorder. Before you decide whether or not to take part, it is important that you understand why this research is being done and what it will involve. Please take the time to read the following information carefully. You may download this information and print it off to read at your own convenience and discuss with others if you wish. If there is anything which is not clear or that you would like more information about please feel free to contact us. Contact details for the research team are at the end of the page.
 

Contents

  1. Background to the Research
  2. What is the aim of the study?
  3. Why do this research?
  4. Who is organising the research?
  5. Who will be taking part in this study?
  6. What will taking part involve for me?
  7. Do I have to take part?
  8. Will my personal details be kept confidential?
  9. Will I receive payment for taking part in the study?
  10. What are the potential advantages and disadvantages of taking part?
  11. What will happen to the results of the research?
  12. Who has reviewed the study?
  13. What if something goes wrong?

Background to the Research

Spectrum Centre researchers in collaboration with clinicians and researchers from other institutions developed a psychological approach for individuals with Bipolar Disorder called Enhanced Relapse Prevention (ERP). This approach is designed to be used by people with experience of bipolar disorder in partnership with support people, including relatives, friends and mental health professionals. In a previous study ERP was found to be effective in reducing relapse and improving functioning for people with bipolar disorder. We have been looking at ways in which we can make ERP available to more people with bipolar disorder who may benefit from it. The Spectrum Centre and Cumbria Partnership NHS Trust have recently been awarded funding from the National Institute for Health Research to develop ERP into an online web-based version, and to assess how well an online version works. ERP-online was developed in the first stage of this research by researchers and clinicians in collaboration with service users.

What is the aim of the study?

This study aims to find out how well ERP online works for the prevention of relapse among individuals with bipolar disorder and how acceptable it is to use. We will explore if individuals with bipolar disorder are interested in receiving Enhanced Relapse Prevention online (ERP-online), how many participants take part in the trial, and if participants participate for the whole of the study. We will also explore how effective the intervention is in reducing relapse for individuals with bipolar disorder compared to participants who continue to receive only their usual treatment. Service users have been involved in designing the study and will be involved in carrying out the research.

Why do this research?

Treatment development studies such as this one are useful to enable the development of psychological interventions which aim to improve quality of life, and reduce associated problems in bipolar disorder, including relapse.

Who is organising the research?

This study is being run by a team of researchers, university academics, a service user researcher, and clinicians from Cumbria Partnership NHS Foundation Trust, the Universities of Lancaster and Nottingham. The team also includes a Service User Reference Group (SURG), whose members are service users and carers from across the North West. The role of the SURG will be to ensure that service user and carer views are central to the study and how it is run.

Who will be taking part in this study?

Up to a total of 125 participants from across the UK will take part in this study. Participants will be aged over 18, will have experience of bipolar disorder and will have had 3 relapses (episodes of mania, hypomania, and/or depression) in their lifetime, with 1 falling in the preceding 2 years. Participants will also need access to a computer and the internet and the ability to understand written and spoken English. Participants must not have a physical cause for their bipolar disorder (e.g., brain injury), have a primary diagnosis of substance or alcohol misuse, currently be in a mood episode and/or being treated under a section of the Mental Health Act, or currently be taking part in another intervention study (including follow-up assessments).

What will taking part involve for me?

If you decide to take part, a Research Assistant will contact you by phone to explain more about the study and to ask some preliminary questions about your history of mood episodes and current mood, to ensure that this is the right study for you. If you are eligible for the study, we will arrange a time to phone you for a further interview about your recent mood experiences. You can have as many breaks as you like during these interviews, and you can stop at any time. We will then ask you to complete some questionnaire measures online. These will ask about your current treatment for bipolar disorder, quality of life, functioning, medication use, and health status.

Following this, you will be randomly allocated to receive either the ERP Online intervention for bipolar disorder plus your current treatment as usual, or you will continue to receive your current treatment plan only, with all existing support remaining in place. This group will be the ‘waitlist control’ group because they will be given access to ERP Online at the end of the study, when all follow-up assessments have been completed. It is important to emphasise that whilst we hope ERP Online will be helpful to people who have recently (within the past 2 years) experienced relapse in bipolar disorder, we do not know this definitively. For this reason, participants in both the intervention and the waitlist control arms of this trial are equally important.

ERP Online is a web-based psychological intervention and includes a series of modules on identifying triggers and early warning signs of mania/depression, developing effective coping strategies to manage these ‘triggers’, and overcoming barriers and care planning.  You will also receive advice on managing your routine, including regulating sleep. The face-to-face version of ERP involves 6 one hour sessions, and we expect working through the ERP Online modules to also take around 6 hours; however, it may take less or more time depending on the individual.  Participants in the intervention arm will receive access to ERP Online after their initial assessment, and will continue to have access to ERP Online once the study has finished.  Those in the waitlist control arm will be given access to ERP Online only after they have completed the study, which will take approximately 12 months.

In order to test the feasibility and effectiveness of this intervention, we plan to conduct follow-up appointments with all research participants every 12 weeks, for a maximum period of 48 weeks. Follow-up appointments will be conducted over the phone and will include an interview about your mood. We expect each interview to take around 1 hour.  You will also be asked to complete online questionnaires after 24 weeks and again at 48 weeks which should take about 30 minutes to complete.  We will also ask for your consent for us to review your clinical notes for additional information about any relapses you may have had. If you are under the care of a mental health NHS trust, a copy of your consent form will be copied into your usual medical notes and this copy may be reviewed by the Trust Clinical Audit Department to confirm that you have given written consent to take part. If you are not under the care of a mental health NHS Trust, we will notify your GP about your participation.

We would also like to explore how acceptable participants in the intervention arm find ERP Online.  For example, we would like to find out how easy you found it to use, the strengths and weaknesses, what changed for you as a result of using it etc. For this purpose, we will contact 20 individuals from the intervention arm to take part in interviews about their experience of using ERP Online. On the study consent form we will ask whether you consent to be contacted about taking part this phase of the study.  Please note that you are under no obligation to take part in the interview even if you indicate that you would like to be contacted about this.  If you decide to involve a relative or health professional in supporting you in using ERP Online, then we may wish to invite them to be interviewed too to find out how they experienced this role. However, we would only contact them if you were happy for us to do so and gave us their contact details.

Do I have to take part?

You are under no obligation to take part in the study.  If you would like to hear more about the study, you can register your details on the website, complete a self-referral form and post this to the research team, or ask your GP or care co-ordinator to complete a referral form on your behalf.  If you do decide to take part, before you begin the study, you will be asked to complete some initial questions on our project website to see whether or not this is the right project for you.  If you answer yes to these questions, you will be asked to complete an online consent form. If you change your mind after giving consent you are free to withdraw from the study at any time. If you do decide not to take part, or to withdraw, this will not affect the standard of care you receive, or your ability to take part in any future research. If you choose to leave the study, you will also continue to receive access to ERP Online (or will still gain access at the end of the study if you are in the waitlist control group). You will be asked to complete a form giving your reason for withdrawing, but do not have to do so.

Will my personal details be kept confidential?

All information (data) that is collected about you during the research will be kept strictly confidential and will be stored securely. All data collected will be anonymised prior to analysis and no participants will be indentified in the write up or publication of the results. We will ask for your consent for audio recordings to be made of your interviews. These recordings will not bear your name, and will only be accessed by the research team. All of your data, including audio recordings, will be stored on a secure folder that only the research team can access. Any data on portable devices (e.g., a USB stick) will be encrypted and password-protected. All files will be password-protected. It is important for us you are assured that all measures will be taken to guarantee the confidentiality and anonymity of your participation. However, you may disclose information that is relevant to safeguarding vulnerable individuals. If such information is disclosed, the data collection will cease, a member of the research team will discuss with you that confidentiality will be broken on this occasion, and the relevant bodies or individuals will be informed.

Will I receive payment for taking part in the study?

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).

What are the potential advantages and disadvantages of taking part?

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. It is our experience of conducting similar research that participants value 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. 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.

What will happen to the results of the research?

If you participate in this study you will be informed of the results at the end of the study. The findings will be presented at appropriate conferences and events and will be published in mental health journals and other publications with the aim of reaching a wide audience of mental health professionals and service users. If the findings of this study indicate that the intervention works well for participants and is effective in reducing relapse in bipolar disorder, we will use these results to seek funding for a larger scale clinical trial of ERP-online. Our eventual aim is to make ERP-online available to all those people in the UK who may benefit from using it.

Who has reviewed the study?

This study has been reviewed and approved by an NHS Research Ethics Committee.

What if something goes wrong?

It is unlikely that you will be harmed by participating in this study. However, if you are harmed by taking part in this research, there are no special compensation arrangements. If you are harmed due to someone’s negligence, then you may have grounds for legal action but you may have to pay for it. The study will be overseen by a Trial Steering Committee. In the event of any possible negative impact that could be directly due to the intervention, the TSC will have the power to withdraw the intervention.

If you do wish to make a complaint, or have concerns about any aspect of the way you have been approached or treated during the course of this study, then in the first instance please contact:

Prof Susan Cartwright, Professor in Organisational Health, Centre for Organisational Health & Well-being, Lancaster University, Lancaster, LA1 4WY.
Telephone: 01524 592430
Email: susan.cartwright@lancaster.ac.uk

Patient Experience Team, Cumbria Partnership NHS Foundation Trust, Carleton Clinic, Cumwhinton Drive, Carlisle, Cumbria, CA1 3SX.
Telephone: 01228 608257/0800 633 5547
Email: PET@cumbria.nhs.uk

Patient Advice and Liaison Service, Blackpool, Fylde and Wyre Teaching Hospitals NHS Foundation Trust, PALS Information Centre, Victoria Hospital, Whinney Heys Road, Blackpool, FY3 8NR.
Telephone: 01253 655588/89
Web: www.bfwh.nhs.uk/visiting/pals/contact.asp

If you would like any further information or have any questions, please contact one of our research assistants:

Adam Sawczuk
Spectrum Centre for Mental Health Research
Division of Health Research
Faculty of Health & Medicine
Lancaster University
LA1 4YG

Telephone: 01524 592977
Email: a.sawczuk@lancaster.ac.uk