Title: Combined individual and family therapy in comparison to treatment as usual for people at risk of psychosis: A feasibility study.
Funder: Department of Health and Social Care

Abstract: Background: There is considerable interest in the ability to identify and treat people considered at an elevated risk of psychosis (1) termed At Risk Mental State (ARMS). A recent meta analysis indicates this is a group at elevated risk of developing psychosis with transition rates after 1 year of 22%, 29% after 2 years and 36% after 3 years (2). Long term follow up has confirmed that the highest rate of transition occurs within the first 2 years (3). Treatment trials to date have found a mean age between 20.8 and 22.9 (4-7) with only one German trial finding a mean age of 25.2 (8). NICE guidelines for the treatment of psychosis and schizophrenia in children and young people have a research recommendation of &ldquo;what is the clinical and cost effectiveness for family intervention combined with individual CBT in the treatment of children and young people considered to be at high risk of developing psychosis and their parents or carers?&rdquo; Aims: The overall aim is to identify people with ARMS, and to investigate whether a combined individual and family CBT (IFCBT) intervention is an acceptable, feasible and potentially effective treatment option. We will also carry out qualitative interviews to understand individuals experiences of therapy and trial participation as well as family members/carers unique experiences. Method/Plan: This feasibility study will apply a randomised design to test the acceptability of the IFCBT intervention. 76 Individuals will be randomised to one of two conditions, in the treatment as usual group they will be monitored for 1 year to assess levels of transition to full psychosis and in the treatment group they will be monitored for one year plus given the IFCBT intervention aimed at minimising transition to psychosis, reducing distress, increasing quality of life and reducing disability. Assessments will be carried out at baseline, 6 month and 12 month follow up. We will also conduct a nested qualitative interview study (n=15-20) with a purposive sub sample and their associated family members/carers (n=15-20) to understand experiences and acceptability of the therapy and research procedures. Clinical Implications: If people meeting ARMS criteria are detected then interventions aimed at reducing these symptoms and associated distress may reduce the chance of a future full blown episode of psychosis. It is widely recognised that developing strategies for working with people in the earliest stages of their mental health problems is an important step forward for mental health services. Early intervention for psychosis services have been comprehensively established throughout England. Developing the early intervention paradigm to incorporate preventative strategies could be seen as a major priority but evidence is required to support this approach, both for detection and intervention strategies. The department of health emphasises the importance of extending services into the community and developing interventions with a focus on health promotion and prevention.

Lay abstract: Psychosis is a mental health problem which affects how someone thinks and views the world around them. Psychosis can involve hearing or seeing things others don t ( hallucinations ), or having beliefs that don t reflect everyday reality ( delusions ). Psychosis may also affect a person's ability to socialise, work and carry out tasks of daily life. The onset of psychosis is a major challenge for everyone involved in his or her care. When people develop psychosis, there is a large cost in terms of suffering, burden, lost output, and treatment. The NHS is keen to look at treatments that may stop someone developing such problems. Prevention is preferable because it is usually more acceptable and is generally associated with fewer side effects. It can also be more cost effective to provide prevention-based treatments. It is possible to identify people at a high risk of psychosis. About one third will develop a full psychosis over 3 years. We now want to look at treatments that can reduce the number of people who develop psychosis. We have used individual treatment with young people experiencing psychosis-type problems in the past, which has been very successful. But we want to do more. We want to find out if adding family therapy as well as providing individual treatment to young people at risk of developing psychosis is helpful. We want to test our intervention and see if young people find it helpful. We will do this in a clinical trial and also ask people how they found taking part. We will need around 60 young people to take part in the clinical trial. Half will be randomly allocated to get the new treatment and half will get their usual treatment plus monitoring. We will also ask some of those young people who take part how they found it.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH