Extrait

Background and study aims Anorexia nervosa is a serious mental health condition where a person keeps their body weight as low as possible. Individuals with anorexia nervosa have been found to have difficulties with cognitive flexibility. Cognitive flexibility is the ability to shift attention. Shifting attention allows individuals to change their thinking and/or behaviour to adapt to changes in the environment. Cognitive Remediation Therapy was designed to improve cognitive flexibility, memory and planning skills through the use of mental exercises, reflection on thinking styles and exploring new ways of thinking in everyday life. Mental exercises include tasks that involve switching attention and estimating. The aims of this study are to investigate the effectiveness and acceptability of Cognitive Remediation Therapy as a component of treatment for anorexia nervosa, and to examine whether Cognitive Remediation Therapy enhances the effectiveness of Cognitive Behavioural Therapy. Who can participate? Women aged between 18 and 65 with anorexia nervosa What does the study involve? Participants are randomly allocated to either Group 1 or Group 2. Participants in Group 1 receive 6 individual sessions of Cognitive Remediation Therapy followed by 6 individual sessions of Cognitive Behavioural Therapy. They also undergo assessments at the start of the study, after the 6 individual sessions of Cognitive Remediation Therapy, and after the 6 sessions of Cognitive Behavioural Therapy. Group 2 receive 6 individual sessions of Cognitive Behavioural Therapy. They also undergo assessments at the start of the study and after the 6 sessions of Cognitive Behavioural Therapy. What are the possible benefits and risks of participating? Participants may feel positive about being involved in research investigating the effectiveness of a new treatment that could benefit future patients. It is hoped that the information gathered will be of value in improving treatment for anorexia nervosa. The time required to participate in the tests may be inconvenient for some participants, but previous studies have found that participants enjoy the tests. Concentration and attention are required throughout the tests and participants’ performance could be adversely affected by fatigue. To reduce the effect of fatigue, participants are offered a break between the tests. Another identified risk is the potential distress of participants. During the tests participants are asked about their eating behaviour and their thoughts/concerns about body shape and weight. The questionnaires are widely used in research and clinical practice with eating disorder patients. There is no evidence to suggest that these tests cause distress, but it is possible that focusing on psychological difficulties may result in some participants experiencing a degree of distress. In the unlikely event that this happens, participants will be encouraged to discuss any upsetting issues with clinical staff within NHS Tayside Eating Disorders Service who are involved in their routine outpatient care. The researcher will liaise with clinical staff and rely on their judgement as to whether specific patients are too emotionally or physically frail to participate. Participation in the study will be confidential, but if there is a risk to the participant or others the researcher will inform a named clinical member of staff within NHS Tayside Eating Disorders Service. This would be discussed with the participant prior to disclosing the information. Only the researcher and her supervisor will have access to identifiable data. Data stored on a computer will be anonymised and password protected. Where is the study run from? NHS Tayside (UK) When is study starting and how long is it expected to run for? April 2012 to July 2013 Who is funding the study? NHS Tayside and University of Edinburgh (UK) Who is the main contact? Moira Cook

Critère d'inclusion

• Anorexia nervosa

Liens

• ictrp
• isrctn