iMAgery Focused Therapy for PSychosis (iMAPS-2): An Assessor-blind Feasibility Randomized Controlled Clinical Trial

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BACKGROUND AND HYPOTHESIS: Intrusive mental images and negative schematic beliefs have been identified as maintenance and possible causal factors for some psychotic experiences, with limited focus in existing therapies in psychosis. Our primary aim was to assess the feasibility and acceptability of undertaking a randomized controlled trial (RCT) of a novel, imagery focused psychological therapy for psychosis (iMAPS). STUDY DESIGN: An assessor-blind RCT (iMAPS-2). Participants who were help seeking; with hallucinations or delusions, who reported distressing intrusive mental imagery were eligible to take part. Participants were randomly assigned (2:1) to receive 12 sessions of iMAPS therapy plus standard care or treatment as usual (TAU). Assessments were undertaken at 0, 16 and 28 weeks. The primary feasibility outcomes were recruitment target, retention at 16 week follow up and number of therapy sessions attended. STUDY RESULTS: The trial recruitment was 100% of target (45 participants). The study had a high rate of retention of 80% (36 participants) at 16-week primary endpoint, a high rate of adherence to the imagery focused therapy (77%) and positive qualitative feedback. There were two serious adverse events in the iMAPS therapy arm deemed unrelated to treatment and zero in the TAU group. CONCLUSIONS: This is the largest trial to date of imagery focused therapy for psychosis, demonstrating it is safe. An adequately powered clinical and cost effectiveness trial is warranted to provide an estimate of the effects of the iMAPS therapy. TRIAL REGISTRATION ISRCTN: 81150786.

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