Source: isrctn - Le promoteur: University of Nottingham (UK)

Evaluation of adjustment groups for people with Multiple Sclerosis Background and study aims? Psychological problems affect the way people cope with their disability. Depression and anxiety are common in people with multiple sclerosis (MS). Improving psychological outcomes may improve quality of life. In addition it could reduce demands on other NHS services. Although drug treatments are available, these are not appropriate for everyone. Psychological treatments may provide an alternative, but there are few high quality randomised controlled trials investigating these for people with MS. Such trials are needed in order to determine whether psychological services should be developed further. The purpose of this study was to find out whether attending group treatment sessions, which offer ways to cope with anxiety and depression, was helpful. We developed a group programme and the feedback from people who attended the groups in our pilot study was very positive. We then wished to conduct a larger study to find out whether these groups should be provided as part of routine clinical practice. The plan was to find out whether the mood of people who were offered a group treatment was better than those who were not offered the treatment and to assess the costs to the NHS of providing the service. Who can participate? People with MS who were known to the MS service in Nottingham What does the study involve? We invited people with MS to complete questionnaires about their mood. Those who had low mood, according to their questionnaire scores, were invited to take part in the study. People were allocated on the basis of chance to attend group treatment sessions or to go on a waiting list. Group A: Everyone was offered 6 fortnightly, group treatment sessions. The sessions lasted about 2 hours, with breaks, and each session had a topic of the day, such as: worry, gloom, relationships, problem solving, and the future. Group B. These people were not offered the group treatment until after the study was completed. They received all other clinical services as usual. At the end of the programme, everyone, both those who attended the group and those who did not, was asked to complete questionnaires. These included measures of mood, quality of life and the impact of MS on their lives to determine the effects of the treatment. These questionnaires were repeated 3 months later to determine whether any benefits were maintained. We also collected information on the costs of providing the service. What are the possible benefits and risks of participating? Participants may have had psychological treatment which would not otherwise have been available. There were no known risks associated with participating in this study. Where is the study run from? The MS service in Nottingham. When is the study starting and how long is it expected to run for? The study started in June 2008 and finished in September 2009 Who is funding the study? Multiple Sclerosis Society (UK) Who is the main contact? Professor Nadina Lincoln [email protected]

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