Extract

Background and study aims We are carrying out a study to examine the effects of a technique known as “expressive writing”, when used with patients who are undergoing dialysis treatment. This technique has been used with lots of other groups of patients before, such as those with arthritis, and it has been shown to have positive effects on their physical health and psychological well-being. The study’s findings should help us to know whether this technique can be applied to patients with kidney failure and whether it has the same benefits for them. Who can participate? The study aims to screen approximately 200 dialysis patients, with the aim of recruiting 50 patients into the expressive writing part of the study. The participants will all be age > 18 years, under the care of Guy's and St Thomas's renal team and undergoing dialysis treatment in three pre-selected hospital clinics. What does the study involve? Participants will initially be required to complete a series of questionnaires concerning a number of factors linked to psychological well-being (e.g., mood, fatigue, distress and illness beliefs). If they are found to meet the inclusion criteria, they will be asked to take part in an expressive writing exercise and be placed randomly into one of two groups (one is an expressive writing group and one a control group). Both groups will write about aspects of their kidney problem and dialysis treatment for 15 to 20 minutes, whilst dialysing, on three consecutive dialysis days. Participants will be asked to complete the same series of questionnaires following the expressive writing exercise (at one week), after 3 months and finally after 6 months. We will also collect some basic data on certain markers of physical health from the participant’s medical notes. The main aim of the study is to see whether the writing procedure is feasible to use with the dialysis population (i.e., whether people agree to take part, whether they drop out, whether are able to complete the task correctly and whether there are any difficulties). The second aim is to see whether there are any benefits of using an expressive writing procedure over a neutral control procedure. At the end of the study, we will compare the measures of wellbeing and health markers before and after the intervention to see whether there is improvement over time and also between groups to see whether the expressive procedure is more beneficial than the non-expressive procedure. What are the possible benefits and risks of participating? It is possible the expressive writing sessions will improve physical health and some aspects of psychological well-being of those taking part. However, this cannot be guaranteed. If it is found to be beneficial, this study may help researchers to develop this procedure so that it can be used with future patients undergoing dialysis treatment, therefore improving their overall quality of life. Although unlikely, there is a small risk of distress caused by the writing sessions as participants may become aware of an issue that they had not previously thought of. The usual risk management procedure will take place if increased distress is identified by researchers and psychologists attached to the renal unit will be on hand to provide support if required. Where is the study run from? This study is being conducted by academic staff and students at the Institute of Psychiatry (IoP), part of King’s College London, alongside a consultant nephrologist who has given permission to recruit patients at three UK dialysis units run by Guys & St Thomas’ NHS Trust. These are Bostock unit and Astley Cooper unit, which are based at Guy’s and St Thomas’ Hospital and one satellite dialysis unit, which are based in Camberwell, London. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will start early 2013. Participants will be enrolled on the study for a period of six months. Who is funding the study? Funding has been provided by the Institute of Psychiatry (IoP), part of King'’s College London. Who is the main contact? 1. Jennifer Hunt ([email protected]) 2. Project Supervisor: Joe Chilcot ([email protected])

Inclusion criteria

• Depression associated with kidney disease

Links

• isrctn
• ictrp