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Abstract
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 & Calgary Depression Scale for Schizophrenia; score > 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).
Acknowledgements
The authors acknowledge the financial support of NHS Research Scotland (NRS), through The Chief Scientist Office (CZH/4/743) and of the Scottish Mental Health Research Network. The research project is adopted and supported by the Scottish Mental Health Research Network.
Disclosure statement
No potential conflict of interest was reported by the authors.