A trauma-focused intervention for people with post traumatic symptoms and psychosis: a study protocol for a randomized clinical trial

Background Trauma-focused therapy is the treatment of choice for post-traumatic symptomatology, with Eye Movement Desensitization and Reprocessing (EMDR) being one of the evidence-based approaches recommended by international clinical guidelines. However, these interventions are often not used for people with psychosis. Although the number of studies in this area is increasing, more randomized controlled trials are needed.Methods and Analysis We have developed a step-by-step trauma-focused intervention that includes EMDR as one of its core components. A single-blinded, multicenter, randomized clinical trial has been designed to assess the feasibility, acceptability, safety and clinical efficacy of the intervention. Participants have long-lasting schizophrenia spectrum disorders and post traumatic symptoms. They will be randomly assigned to the intervention group or to treatment as usual waiting list control group. The intervention is delivered as an add-on within a public psychosocial rehabilitation service network. The intervention protocol is outlined, describing the criteria for assessing feasibility, acceptability and safety, and details of the clinical outcomes that will be assessed.Discussion This paper describes the trial design and the intervention protocol developed to evaluate the safety and effectiveness of a trauma-focused treatment for individuals with long-standing psychosis.