Extrait

Background and study aims The aim of the study is to run a small trial of a new, recovery-focused, brief cognitive behavioural therapy (CBT) treatment for people with psychosis: the GOALS study (‘Getting On top of Anxiety and Low mood and So achieving your goals’). The therapy will be delivered by frontline mental health staff over eight weekly sessions, following brief training and ongoing supervision with a clinical psychologist. The intervention (treatment) aims to improve recovery, social inclusion and social functioning and reduce distress, and in this study, will be evaluated in comparison to a “treatment as usual” control group. The will inform the further development of the treatment and training and will provide information for a larger multi-centre trial. Who can participate? The GOALS study aims to recruit around 65 adults with a diagnosis of psychosis and who have difficulties in their daily functioning due to anxiety-related avoidance and/or depression. Participants will be recruited from early intervention and recovery teams within the local National Health Service Trust. What does the study involve? Participants who give their consent to take part in the study will meet with a researcher three times to complete a number of questionnaires asking about thoughts, feelings, beliefs and experiences. Each meeting will last around 1.5 hours and will be at the beginning of the study, 8 weeks later and 16 weeks later. After the first meeting, half of the people taking part will be randomly chosen to receive the therapy straight away and half will be offered therapy in four months. Everybody will be asked to complete all of the questionnaires in order to compare the therapy with usual treatment. Those who have therapy straight away will meet with a trained staff member at their clinical team for 8 weekly one-to-one meetings and one follow-up meeting a month later. The therapy aims to support participants to work towards a personal goal which they are finding difficult to complete due to anxiety or depression. Those who are allocated to the control group will continue to receive their usual care, but will be offered the therapy once they have completed all of the questionnaires. In addition we will ask a quarter of people taking part to give some additional feedback on how they found the meetings with staff and how they could be improved. What are the possible benefits and risks of participating? In a pilot study almost all participants achieved their goals and many showed improvements in mood and wellbeing. All participants will be offered the intervention including those allocated to the treatment as usual group should they wish, after completion of the measures. It is not expected that participation in the study has any risks. The staff who will be delivering the therapy are trained in managing patient distress and will be working within participants’ clinical teams. Participants will be free to take a break at any point during the meetings and are free to withdraw from the study at any point. Where is the study run from? The study has been set up by the Institute of Psychiatry and will be conducted within the South London and Maudsley NHS Foundation Trust. When is the study starting and how long is it expected to run for? The study is due to begin in February 2013 and the end date for the project is August 2015. Who is funding the study? The study is funded by the National Institute for Health Research, Research for Patient Benefit funding stream. Who is the main contact? Dr Helen Waller [email protected]

Critère d'inclusion

• Psychosis ? early intervention and recovery

Liens

• ictrp
• isrctn