Title: Cognitive behaviour therapy in comparison with antipsychotic medication and a combined intervention in adults with psychosis
Funder: Department of Health (England)

Abstract: Management of schizophrenia, a common form of psychosis, is amongst the largest challenges for the NHS and is repeatedly a priority for policy makers, commissioners and service providers, on the basis of significant personal, social and financial costs. Whilst antipsychotics (APs) are the first line of treatment for schizophrenia, there is mounting evidence that many service users choose to refuse or discontinue their pharmacological treatment. There is emerging evidence that the effectiveness of APs has been over-estimated and their toxicity underestimated 1. Meta-analyses show that, while there may be demonstrable effects of APs in comparison to placebo, the improvements over placebo are not as great as previously thought 2. There is also recent evidence to suggest that the adverse effects of antipsychotics have been under-estimated3 4. A recent Cochrane review of studies examining the effectiveness of APs in comparison to placebo or psychosocial interventions in early schizophrenia patients concluded that the data are too sparse to assess the effects of APs outcomes in early schizophrenia 5, and international experts on early psychosis also argue that there is currently equipoise on this issue 6. There is new evidence that CBT for psychosis can be acceptable and effective in reducing psychotic symptoms in those who choose not to take APs 7. Our current RCT that is examining CBT for people who have chosen not to take APs has recruited over target in Manchester, showing feasibility of recruitment to a trial involving CBT without APs 8. The new NICE guideline for treatment of psychosis and schizophrenia in children and young people suggests that treatment options for first episode psychosis should include the possibility of choice regarding CBT, APs or the combination, and has an explicit research recommendation regarding “what is the clinical and cost effectiveness of psychological treatment alone, compared with antipsychotic medication and compared with psychological treatment and antipsychotic medication combined?”. We aim to conduct a pilot randomised controlled trial (RCT) of antipsychotic medication compared to CBT and a combined treatment, in adults with psychosis, to inform a definitive phase III trial. Our objectives are to assess recruitment rate, quality of data collection and follow-up, the integrity of the treatment protocols, the appropriateness, feasibility, safety and acceptability of the interventions and the relevance and validity of the measures to assess effectiveness, safety, acceptability and cost effectiveness. We also aim to provide data for sample size estimates for the definitive trial and to conduct a service user-led qualitative evaluation. We plan to conduct a pilot single-blind RCT to compare CBT and APs and a combination of the two in adults with psychosis, with 25 participants in each group. Randomisation will be independent and concealed, stratified by gender and first episode status and using randomised-permuted blocks of 4-6. Assessors will be masked to allocated treatment. We will examine improvements in symptoms, functioning, quality of life and well-being, as well as side effects and acceptability. We will also conduct qualitative interviews with participants to examine their views of the different treatments. These studies will inform a definitive, pragmatic clinical and cost effectiveness trial. We will have clearly defined procedures for initiation of additional treatment for participants who deteriorate to a clinically significant extent. There is no evidence comparing relative effectiveness of CBT and APs. This research will provide commissioners with valuable data for improving choices for consumers and equip service providers with information regarding alternative evidence-based interventions. Most importantly, it will empower service users and carers with informed choices.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;6.1 PHARMACEUTICALS
Health categories: MENTAL HEALTH