Abstract
BackgroundPersecutory delusions are the most common type of delusions in psychosis and present in around 10–15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotional processes. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms. Our aim is to test the clinical feasibility of a novel psychological intervention, which manipulates biased interpretations toward more adaptive processing, in order to reduce paranoia in patients.MethodsThe ‘Cognitive Bias Modification for paranoia’ (CBM-pa) study is a feasibility, double-blind, randomised controlled trial (RCT) for 60 stabilised outpatients with persistent, distressing paranoid symptoms. Patients will be randomised at a 50:50 ratio, to computerised CBM-pa or a text-reading control intervention, receiving one 40-min session per week, for 6 weeks. CBM-pa involves participants reading stories on a computer screen, completing missing words and answering questions about each story in a way that encourages more helpful beliefs about themselves and others. Treatment as Usual will continue for patients in both groups. Patients will be assessed by a researcher blind to allocation, at baseline, each interim session, post treatment and 1- and 3-month follow-up post treatment. The primary outcome is the feasibility parameters (trial design, recruitment rate and acceptability) of the intervention. The secondary outcomes are clinical symptoms (including severity of paranoia) as assessed by a clinical psychologist, and ‘on-line’ measurement of interpretation bias and stress/distress. The trial is funded by the NHS National Institute for Health Research.DiscussionThis pilot study will test whether CBM-pa has the potential to be a cost-effective, accessible and flexible treatment. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a fully powered RCT will be warranted.Trial registrationCurrent Controlled Trials ISRCTN: 90749868. Retrospectively registered on 12 May 2016.
Highlights
Persecutory delusions are the most common type of delusions in psychosis and present in around 10–15% of the general population
Over one third of all UK psychiatric patients suffer from persecutory delusions, and they are reported in depression [6], bipolar disorder [7], posttraumatic stress disorder [8], anxiety [9], and with the highest prevalence and greatest intensity in schizophrenia [10]
Persecutory delusions are at the severe end of a paranoia spectrum, associated with poorer health, emotional wellbeing and social functioning [2], and for which treatments need to be significantly improved
Summary
Persecutory delusions are the most common type of delusions in psychosis and present in around 10–15% of the general population. Persecutory delusions are the most frequent and clinically significant symptoms of psychosis. They are associated with considerably more distress than other types of delusion [3]; are most likely to be acted upon [4] and represent a strong predictor of hospitalisation [5]. A significant proportion of patients suffering from persecutory delusions, continue to experience distressing symptoms despite available treatments [11, 12]. Persecutory delusions are the extreme point on the continuum of paranoid belief, and are likely to be perpetuated by biased cognitive-emotional processes [13,14,15,16,17,18]
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