Mindfulness-Based Crisis Interventions for patients with psychotic symptoms on acute psychiatric wards (amBITION study): protocol for a feasibility randomised controlled trial

BACKGROUND Inpatient psychiatric care is a scarce and expensive resource in the National Health Service (NHS), with chronic bed shortages being partly driven by high re-admission rates. People often need to go into hospital when they have a mental health crisis due to overwhelming distressing psychotic symptoms, such as hearing voices (hallucinations) or experiencing unusual beliefs (delusions). Brief talking therapies may be helpful for people during an acute inpatient admission as an adjunct to medication in reducing re-admission rates, and despite promising findings from trials in the USA, there have not yet been any clinical trials on this kind of intervention within NHS settings. METHODS/DESIGN The amBITION study is a feasibility randomised controlled trial (RCT) of a manualised brief talking therapy (Mindfulness-Based Crisis Intervention; MBCI). Inpatients on acute psychiatric wards are eligible for the study if they report at least one positive psychotic symptom, and are willing and able to engage in a talking therapy. In addition to treatment as usual (TAU), participants will be randomly allocated to receive either MBCI or a control intervention (Social Activity Therapy; SAT) which will be based on doing activities on the ward with the therapist. The primary objective of the study is to find out whether it is possible to carry out this kind of trial successfully within UK inpatient settings and to find out whether patients and staff find it an acceptable intervention. The secondary objective is to collect pilot data on primary and secondary outcome measures, including re-admission rates at 6 month follow-up. This will provide information on the appropriateness of re-admission as the primary outcome measure for future efficacy trials, as well as data on the acceptability and utility of the clinical self-report measures. DISCUSSION The results of the feasibility trial will indicate whether a subsequent efficacy pilot trial is warranted, and if so, will provide vital information for the planning of such a trial (e.g. pilot data on expected effect sizes). If future research finds that MBCI is an effective and safe intervention, then patients will benefit from access to better treatment within inpatient care which would reduce re-admission rates. This trial therefore addresses an area of urgent concern for service users, clinicians and the wider NHS. TRIAL REGISTRATION ISRCTN37625384.