The 'Reducing Psychosis Risk by Targeting Trauma' Trial: Protocol of a Feasibility Randomised Controlled Trial of Trauma-Focused Cognitive Behavioural Therapy and Eye Movement Desensitisation and Reprocessing Therapy for People With At-Risk Mental States

“通过针对创伤降低精神病风险”试验:一项针对高危精神状态人群的创伤聚焦认知行为疗法和眼动脱敏再加工疗法可行性随机对照试验方案

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Abstract

BACKGROUND: Trauma exposure is pervasive in people with an At Risk Mental State (ARMS) and is associated with adverse clinical and functional outcomes. While promising developments have been made in treating trauma in psychosis, evidence regarding the efficacy of trauma therapies in ARMS individuals is limited. This trial aims to evaluate the feasibility of conducting a future randomised controlled trial (RCT) to determine the efficacy of Eye Movement Desensitisation and Reprocessing (EMDR) and trauma focused cognitive behavioural therapy (TF-CBT) in people with ARMS. METHOD: Seventy ARMS individuals with a history of trauma will be randomised to receive 24 sessions of EMDR plus treatment as usual (TAU), 24 sessions of TF-CBT+TAU, or TAU alone. Feasibility will be determined against pre-specified thresholds for recruitment, retention, treatment engagement, and fidelity. To examine the promise of efficacy of EMDR and TF-CBT, participants will complete a battery of clinical and mechanistic measures at baseline and 9-month post-randomisation, including assessments of attenuated psychotic symptoms and post-traumatic symptoms. Clinical notes will be reviewed to identify transitions to first episode psychosis up to 12 months post-randomisation. Qualitative interviews with trial participants, therapists, and professional stakeholders will explore the acceptability of EMDR and TF-CBT and factors to facilitate future implementation of trauma therapies in routine practice. CONCLUSIONS: If a large-scale RCT is deemed feasible, it will be possible to establish whether EMDR and/or TF-CBT represent beneficial treatments to augment existing evidence-based care for individuals at ultra-high risk for future psychosis, potentially reducing transition rates and improving clinical outcomes for ARMS individuals.

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