Randomised Controlled Trial

Participant Information Sheet

What is the aim of this study?

This study aims to develop and test a new free to access web-based self management intervention for people experiencing Bipolar Disorder.

Why are we doing this?

There is evidence that many people with Bipolar Disorder want psychological therapy and that it works well for a great deal of people. However, there are inequalities in access to psychological therapy in the NHS, meaning not everyone is able to receive this kind of help.

By developing a web-based self management intervention we aim to increase access to psychological therapy through a novel web-based interface, which means people can access when and wherever they want and without having to be on a waiting list.

Who can take part?

  • Are aged over 18 years.
  • Have a diagnosis of Bipolar Disorder.
  • Live within the UK and can understand written English.
  • Have access to a computer, email account and printer.

What is a randomised controlled trial?

A randomised controlled trial (RCT) is the best type of research to find out the clinical effectiveness of a new treatment. To find this out we need to compare the new treatment against treatment that people would normally receive. We therefore put people into groups, and give one group the new treatment alongside their normal treatment, and the other only undertake their normal treatment. The results are then compared to see which one is better. To make sure the groups are the same to start with, each participant is put into a group at random (by chance).

The Living with Bipolar randomised controlled trial.

This is the second part of the study where we are looking for participants to take part in a trial to test the clinical effectiveness of the web based self management intervention. We are currently in the final stages of preparing this intervention for the clinical trial.

If you agree to be contacted, you will be contacted by email or letter when we are ready to test the intervention, providing you with more information about the trial and inviting you to take part.

If you then agree to take part you will be placed at random in one of two groups:

  1. A group where you have access to the Living with Bipolar intervention for 6 months alongside your normal treatment.
  2. A group where you do not get access to the intervention but receive your normal treatment. If you are placed in this group you will have access to the intervention at the end of the trial. This should be September 2012.

We will then ask you, whichever group you are in, to complete a number of questionnaires to find out how you are getting on. The results of these measures will be compared to see which treatment is better; either the usual treatment on its own or with access to the intervention.

Why should I register my interest in this trial?

You will have access to a new intervention for Bipolar Disorder that has the potential to improve the lives of others living with Bipolar Disorder as part of the trial or after the study has been completed. This should be September 2012.

What will happen to the results of the research?

The results of this trial will be published in scientific journals, and in magazines for mental health service users, carers and mental health professionals. If the intervention is successful mental health professionals reading the journals will be able to recommend the intervention to their service users. In addition, service users reading the magazines will be able to access the intervention themselves. You will have the option to receive a summary of the findings when we run the trial.

Who is organising and funding this research?

We are a group of three researchers. Nicholas Todd, Dr. Fiona Lobban and Professor Steven Jones and work at Lancaster University. We have been funded by Mersey Care NHS Trust to undertake this research for three years.

How can I contact you for more information?

If you would like any further information about this project, or would like to talk to someone before taking part, please contact Nicholas Todd on the contact details at the bottom of this page.

How can I register my interest in being contacted about the Randomised Controlled Trial?

Register your interest now!

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