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
Filippo Varese, Kim Cartwright, Amanda Larkin, Marina Sandys, Aidan Flinn, Alice Newton, Jasmine Lamonby, Mica Samji, Clare Holden, Samantha Bowe, David Keane, Nadine Keen, Amy Hardy, Debra Malkin, Richard Emsley, Kate Allsopp
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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.
期刊介绍:
Early Intervention in Psychiatry publishes original research articles and reviews dealing with the early recognition, diagnosis and treatment across the full range of mental and substance use disorders, as well as the underlying epidemiological, biological, psychological and social mechanisms that influence the onset and early course of these disorders. The journal provides comprehensive coverage of early intervention for the full range of psychiatric disorders and mental health problems, including schizophrenia and other psychoses, mood and anxiety disorders, substance use disorders, eating disorders and personality disorders. Papers in any of the following fields are considered: diagnostic issues, psychopathology, clinical epidemiology, biological mechanisms, treatments and other forms of intervention, clinical trials, health services and economic research and mental health policy. Special features are also published, including hypotheses, controversies and snapshots of innovative service models.