Successful Treatment Of Paranoia Trial, 2024

Paranoia - defined as distressing worries about harm from others- is a common experience that can significantly impair daily life. Despite the burden it causes, many people experiencing paranoia do not access mental health services. Digital interventions offer an important opportunity to expand access to evidence-based support. The STOP (Successful Treatment of Paranoia) app is a stand-alone smartphone intervention that uses cognitive bias modification techniques to help users consider alternative interpretations of ambiguous, real-life social situations.

This study reports on data collected as part of a three-arm, double-blind, randomised controlled trial (RCT) designed to evaluate the efficacy and safety of STOP. A total of 274 participants with self-reported paranoia were recruited across clinical and non-clinical populations and randomly assigned to a 6-week STOP intervention, a 12-week STOP intervention, or an active control condition involving text reading. Participants completed assessments at baseline, post-treatment, and 18- and 24-week follow-up. The primary outcome was paranoid ideation; secondary outcomes included other clinical symptoms, recovery, and interpretation bias as a potential mechanism of change.

The trial achieved an 85% follow-up rate for the primary outcome at 24 weeks, and 88% of participants adhered to the treatment as per protocol. Adverse event rates were similar across trial arms, and all serious adverse events were determined to be unrelated to the intervention. Findings indicated that the 12-week version of STOP led to greater reductions in paranoia symptoms compared to the active control, with more modest improvements seen in the 6-week arm.

These results support the feasibility, safety, and potential clinical utility of STOP as a scalable digital intervention for paranoia. Future iterations should focus on enhancing personalisation to increase therapeutic relevance and maximise clinical benefit.