A parallel group randomised open blinded evaluation of acceptance and commitment therapy for depression after psychosis: a pilot trial protocol (ADAPT)

Background: Depression is one of the major contributors to poorer quality of life among individuals with psychosis and schizophrenia. Aims: This study protocol was designed as a pilot trial to determine the parameters of a larger, definitive pragmatic multi-centre randomised controlled trial of Acceptance and Commitment Therapy for depression after psychosis (ACTdp) for individuals with a diagnosis of schizophrenia who also meet diagnostic criteria for major depression. Methods: The study protocol was registered before initiating recruitment and was designed as a Parallel-group Randomised Open Blinded Evaluation (PROBE) comparing ACTdp plus standard care (SC) or SC alone. Participants were required to meet DSM-IV-TR criteria for schizophrenia and major depression (confirmed by Structured Clinical Interview for DSM/SCID-I and Calgary Depression Scale for Schizophrenia; score gt; 7). Blinded follow-ups are undertaken at 5 months (end of treatment) and at 10 months (5 months post treatment). Implications: The pilot aims to establish the basis for a larger-scale multi-centre randomised controlled trial of ACTdp. The most important study outcomes that will provide the basis of informing progression to a full trial are identified a priori as Population, Intervention, Control and Outcomes (PICO).