Extrait

Background and study aims People with Eating Disorders (EDs) have socio-emotional difficulties. In particular, they show a bias towards negative information about the self and others’ attitudes. Previous studies from our unit found an attentional bias towards critical and angry faces, and lower implicit self-esteem and self-compassion in EDs than healthy subjects. A computerized training programme has been developed that aims to modify negative cognitive bias to social and self-relevant stimuli. The aim of this study is to test the acceptability and impact of this programme on clinical symptoms, interpersonal functioning (between self and others), and self-evaluation in patients with EDs. Who can participate? Participants suffering from an eating disorder can participate in this study. What does the study involve? Participants will meet the researcher four times, on four different days, over the course of 7-10 days. During the first day (baseline; 60 min), subjects will complete a set of questionnaires. Then, participants will randomly allocated to one of four groups: 1. Attentional Bias intervention (experimental) group 2. Attentional Bias control group 3. Self-Esteem intervention (experimental) group 4. Self-Esteem control group. The experimental groups will receive computerized training (training session 1 - day 2; training session 2 - day 3; training session 3 - day 4) to develop a bias towards others (module 1) and self-related positive information (module 2). Participants in the control groups receive a different version of the training, where both positive and negative information are presented. At the end of the last training session (day 4), all participants will complete follow-up measures of clinical symptoms, implicit and explicit self-esteem, interpersonal functioning, vigilance to social stimuli and interpretation of social situations (45 min). Participants in the control group will be offered the intervention at this stage. What are the possible benefits and risks of participating? We hope that this intervention will be associated with a reduction of negative bias towards self- and others-related information and with improved self-esteem and social functioning in people with eating disorders. We also hope this intervention will be associated with a reduction of the eating disorders symptoms. The study will be testing participants with eating disorders who may be considered as at risk. They may experience mild distress or discomfort in completing some of the questionnaires because of the topics investigated (i.e., symptoms associated with the eating disorder). Also, participants may find it somewhat stressful to be involved in the study for a relatively long period of time (about 1 month). Throughout the study, precautions will be made to ensure that the participants are as protected as possible. If interested in taking part in the study, participants will be able to contact the researcher directly by email or telephone, to schedule an appointment with them. Otherwise, they could choose to let their consultant or primary nurse on the site know so that they contact the researcher by email or phone for the patient to schedule an appointment with them. During the face-to-face meeting with the researcher, the patient will be able to discuss the details of the project. Before agreeing to sign the consent form, the researcher will review the information sheet with the participant, offering them the opportunity to ask questions, and will remind the participant that they are free to withdraw at any time without having to specify a reason. During the screening phase, participants will be interviewed to understand whether they are eligible to take part. While completing the questionnaire materials, participants will be invited to take breaks as needed. Participants will also be invited to express the reasons for their distress so that they can be provided with additional guidance and support to address these issues. They will be reassured and reminded that they can withdraw from the study at any point. In case this reassurance is not sufficient to alleviate participant distress, they will then be asked to speak with Prof. Treasure, who has several years of experience working with people with Eating Disorders. Where is the study run from? The study sessions with volunteers from the local community will take place at King’s College London. The study sessions with outpatients and inpatients will take place at South London and Maudsley NHS Foundation Trust. When is the study starting and how long is it expected to run for? The study started in October 2013 and will run for 2 years. Who is funding the study? The Psychiatry Research Trust, UK. Who is the main contact? Dr Valentina Cardi, [email protected] Miss Charlotte Rhind, [email protected] Prof. Janet Treasure, [email protected]

Critère d'inclusion

• Eating disorders

Liens

• isrctn
• ictrp