What is the aim of this study?
The aim of this study is to look at what type of support is best for patients receiving guided self-help. Guided self-help is a recommended treatment for eating disorders that involves reading through a self-help book, with the support of a trained therapist. We are looking at whether this support should be face-to-face (which involves people coming to our department) or provided via e-mail.
There have been very few studies comparing these different types of treatment. We are running a “randomised controlled trial” to try to find out if these treatments have similar effects. The book is called Overcoming Binge Eating and is written by Professor Christopher Fairburn, a leading expert in eating disorders. You will be given your own copy of this to use. The treatment comprises attendance at 10 sessions over a period of 12 weeks, or around the same amount of e-mail contact. You are asked to read the book and follow the self-help programme, and can access support from your therapist.
How many patients are involved?
We are recruiting in Oxfordshire (the ‘main’ site), Buckinghamshire, and Wiltshire and are looking for around 100 people. Male or females who are appropriate for the study will be provided with information and asked if they wish to participate. They will be randomised (see below) to a treatment group, and we will then look at how helpful these treatments are.
What is randomisation?
In this study, we have three groups:
- Patients who receive guided self-help with face-to-face support from a therapist (in person)
- Patients who receive guided self-help with e-mail support from a therapist
- An equivalent (i.e., the same length of time) waiting list
If you agree to take part, a member of our research team will place you at random in one of the three groups. Due to the design of the study, you are not able to choose which treatment you receive, although you will have the right to drop out from the study. All therapists are trained in the treatment given, and are supervised by a senior member of staff. The evidence suggests that treatments (1) and (2) are about as effective as each other. If you are entered into the waiting list condition (3), we will ask you to come back to the Eating Disorder Service in 12 weeks’ time to be reassessed. You will then be put into one of the other two treatments. This means that, if you are randomised to condition (3), you will have to wait at least 12 weeks before you receive treatment. You will then be offered treatment immediately.
Who is leading this research?
This research is being led by Dr. Paul Jenkins, a Clinical Psychologist with the Eating Disorders Service and Honorary Research Fellow at the University of Birmingham.
Who has reviewed this study?
This study has been reviewed and approved by the local Research Ethics Committee (Oxford B). Oxford Health NHS Foundation Trust provides indemnity (liability for harm) the study and also acts as the sponsor, ensuring that proper arrangements have been followed. They may wish to look at your data for monitoring and regulation purposes (e.g., audit).
What will happen to the results of the research?
The results will be shown to the local NHS trust (Oxford Health NHS Foundation Trust) and possibly to the Department of Health. We will also want to publish results in scientific journals, at conferences, and for other professionals who may be interested in the outcomes. Please rest assured that no individual data will be used (results are reported as summaries of the whole group) and your name will not be included. If you want a copy of the results, please indicate this on the Consent Form and we will send it to you when it is completed. We cannot promise that this treatment will help you but the information we get will help us understand how best to help people with eating disorders.
Do I have to participate?
No. It is entirely up to you whether you choose to be in this trial or not. If you decide to participate, we will ask you to sign a Consent Form saying that you understand the aims of the research. If you decide to take part, you will be free to stop at any time (without giving a reason) and this will not affect your care or rights. You can ask to be taken out of the trial, but continue with treatment (i.e., your data will not be used). If you decide not to take part in the study, you will go on to our standard treatment waiting list and will receive treatment as usual. This will probably be individual psychological therapy but we will talk about this with you.
What will happen to me if I agree to participate?
If you agree to participate, you will begin a treatment as soon as possible. You will meet with a researcher shortly before the start of therapy, at the end of therapy, and 6 months after therapy. These meetings should take about 30 minutes. We would like to look at your questionnaires and medical notes for further detail (such as age, your diagnosis, and so on). We will inform your GP of your entry in the study. If the researcher is concerned about your health, or the safety of others, they will discuss this with your therapist, who may wish to speak to you directly. This is to protect your safety, as well as that of others.
Last updated: 17 August, 2017