Title: The acceptability and effectiveness of cognitive behaviour therapy for the treatment of posttraumatic stress disorder within schizophrenia
Funder: Department of Health (England)

Abstract: Background Schizophrenia affects about 1% of the population, and direct treatment costs to the NHS have been estimated at over £2 billion per year. The development of psychological interventions for schizophrenia is an NHS priority. Several studies, including one conducted within our own Trust, suggest that up to 40% of these patients suffer from co-morbid posttraumatic stress disorder (PTSD). However, to date, there have been no clinical trials to evaluate the effectiveness of a psycholgical intervention for the treatment of PTSD within this group. A CBT package has been carefully designed for this group, and a pilot study suggests a high level of patient acceptability. Aims The main aim of the study is to evaluate the effectiveness and cost-effectiveness of the proposed CBT package when compared to routine psychiatric care, and to assess the patient acceptability of the intervention. It is proposed that the intervention will directly reduce PTSD symptom severity, with secondary benefits in reduced levels of schizophrenia symptoms It is also proposed that the participants who receive CBT will require less input from psychiatric and medical services during the course of the trial. Therefore, the project aims to benefit patient wellbeing and to provide information to be used within mental health service planning. Should the intervention prove effective, we aim to disseminate the treatment in the form of a manualised CBT package for training within the NHS. Plan of Investigation Fifty-two participants who are diagnosed with schizophrenia/schizo-affective disorder and PTSD will be randomly allocated to receive either the proposed CBT package or routine psychiatric care. The CBT package includes 16 sessions to be conducted within a 6-month period. Currently employed NHS clinicians will be trained to conduct the intervention as part of their routine clinical practice. Symptoms and level of use of NHS services will be assessed at baseline (week 0), end of therapy (6 months) and after a 6-month follow-up period (12 months). The primary outcome will be level of PTSD symptoms at end of treatment, as measured by the Clinician Administered PTSD scale (CAPS). Acceptability of the intervention will be assessed through a service-user led interview. Potential Impact The described co-morbid presentation is associated with an increased severity of symtoms, high levels of substance use and frequent use of medical and psychiatric services. The proposed intervention has the potential to provide a significant benefit to patients. Also, the planning of services will benefit from the data on cost-effectiveness. Should the intervention prove to be effective, then the research team are ideally placed to maximise the impact of the study through varied forms of dissemination. The proposed design involves training current NHS staff to conduct the CBT, and is therefore directly transferable to a model of NHS dissemination. Assessment of patient acceptability of the intervention will directly address clinicians concerns about treating PTSD within schizophrenia.


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