Cognitive therapy Or Medication for Psychosis: A Randomised Evaluation
Research type
Research Study
Full title
A pilot study of a randomised controlled trial of antipsychotic medication in comparison to cognitive behaviour therapy and a combined treatment in adults with psychosis
IRAS ID
137559
Contact name
Anthony Morrison
Contact email
Sponsor organisation
Greater Manchester Mental Health NHS Foundation Trust
Research summary
Psychosis is a mental health problem, which often lasts many years. It affects behaviour, thinking and perception, as well as a person’s ability to socialise, work and carry out tasks of daily life. Common symptoms of psychosis are unusual beliefs (‘delusions’) and hallucinations (most often, hearing voices). The standard medication (’antipsychotics’ or ‘APs’) for these problems is often helpful but can have serious side effects. There is also evidence that having a talking therapy (‘cognitive behaviour therapy’ or ‘CBT’) can help reduce such symptoms. However, there is little evidence to support the use of one treatment over the other in terms of symptom reduction, especially in early phases. Also, other important results of treatment have not been measured, such as recovery defined by service-users themselves, or how well the person copes with daily life, relationships and the demands of a job or education. Therefore, we plan to conduct a pilot study to explore the feasibility and acceptability of CBT and APs and a combination in adults with psychosis. We will provide roughly a third of participants in the research trial with CBT, a third with APs and a third with both. Which treatment they get will be randomly determined so that the treatments can be compared in similar groups of people. We will measure symptoms, functioning, quality of life and well-being, side effects and acceptability. We will also conduct qualitative interviews with participants to examine their views of the different treatments. We have a track record of successful clinical trials of both CBT and APs for schizophrenia and early psychosis. We will have a clearly defined safety protocol for participants who deteriorate to a clinically significant extent. The data from this study will help to plan a large multi-site trial that will examine clinical and cost-effectiveness
REC name
North West - Preston Research Ethics Committee
REC reference
14/NW/0041
Date of REC Opinion
29 Jan 2014
REC opinion
Favourable Opinion