Extrait

Background and study aims People who have experienced a first episode of psychosis can have more episodes of psychosis; in fact, about 80% of people will have another episode within 5 years of their first episode. Therefore, this early period of psychosis is a critical period. Factors that put people at higher risk of experiencing more episodes of psychosis include not taking medication as prescribed, feeling criticised by a significant other, misusing substances, and isolating oneself from others. National guidelines for medical care recommend a talking therapy, called Cognitive Behavioural Therapy (CBT), for the treatment of psychosis. Unfortunately, less than 10% of people with psychosis who could benefit have access to this talking therapy. To overcome this problem of getting help, we will develop a mobile phone application (Actissist). We will see if it is possible to deliver CBT through a mobile app. We will also see whether people who have experienced psychosis will like to use the app. We wish to understand whether using the app helps people feel less upset by critical comments, use substances less, reduces the distress caused by psychotic symptoms and helps people get out of the house more often. Who can participate? Adults with early psychosis who are in contact with Early Intervention Services. What does the study involve? Participants will be randomly allocated to one of two groups: the treatment group or the control group. Twenty four people in the treatment group will be asked to use the app Actissist on top their usual treatment, and 12 people to use another smartphone app (ClinTouch). ClinTouch monitors symptoms of psychosis and mood symptoms. People will use these apps for 12 weeks. Before using the app, participants will fill out some questionnaires. People who receive the Actissist app will meet with a researcher to talk about strategies that usually help them cope with upsetting symptoms. This way, we can make the app personal to the participant. Participants will also be offered a training session on how to use the app and will be phoned by a researcher weekly to see how they are getting on with using the app. After 12 weeks of using the apps, participants will be invited to fill out the same questionnaires they filled out before receiving the apps. We would like to know what it's like for people to use the Actissist app and also what it was like for people to be involved in the study. To find this out, a small number of participants will be invited to attend an interview at the end of the 12-week study period at a convenient location and time. What are the possible risks and benefits of participating? We don't know if the Actissist app will improve the areas we hope it will. Our participants will be making an important contribution to the development of a new app that could improve access to treatment for people with experience of psychosis. Some people enjoy completing the tasks involved in research and the opportunity to talk to someone about their experiences. We will ask all participants if they want us to share the information we collect with their care team (participants can choose either way), which they may find useful. The Actissist app may challenge personal beliefs and values, which some people may find difficult. However, CBT is safe when delivered face-to-face and more often than not serves to help people, with little proof that it may have a negative effect. This study is very similar to previous research (e.g. in the development of ClinTouch) and very few people have reported feeling distressed by it. Where is the study run from? The study is being run from the University of Manchester. Working with various different Early Intervention teams based in several trusts, we aim to recruit participants from across the North West of England. When is the study starting and how long is it expected to run for? March 2015 to June 2016. Who is funding the study? Medical Research Council (MRC) (UK). Who is the main contact? Dr Sandra Bucci [email protected]

Critère d'inclusion

• Topic: Mental Health; Subtopic: Psychosis; Disease: Psychosis

Liens

• ictrp
• isrctn