Testing the combination of Feeling Safe and Peer Counselling against Formulation-Based Cognitive Behavior Therapy to promote Psychological Wellbeing in People with Persecutory Delusions: Study Protocol for a Randomized Controlled Trial (the Feeling Safe-NL Trial).

Abstract

Abstract Background: Persecutory delusions are strong threat beliefs about others’ negative intentions. They can have a major impact on patients’ day-to-day life. The Feeling Safe Programme is a new translational cognitive-behavior therapy that helps patients modify threat beliefs and relearn safety by targeting key psychological causal factors. A different intervention approach, with growing international interest, is peer counselling to facilitate personal recovery. Combining these two approaches is a potential avenue to maximize patient outcomes. This combination of two different treatments will be tested as the Feeling Safe-NL Programme, which aims to promote psychological wellbeing. We will test whether Feeling Safe-NL is more effective and more cost-effective in improving mental wellbeing and reducing persecutory delusions than the current guideline intervention of formulation-based CBT for psychosis (CBTp). Methods: A single-blind parallel group randomized controlled trial for 190 out-patients who experience persecutory delusions and low mental wellbeing. Patients will be randomized (1:1) to Feeling Safe-NL (Feeling Safe and peer counselling) or to formulation-based CBTp, both provided over a period of 6 months. Participants in both conditions are offered the possibility to self-monitor their recovery process. Blinded assessments will be conducted at 0, 6 (post-treatment), 12, and 18 months. The primary outcome is mental wellbeing. The overall effect over time (baseline to 18-month follow-up) and the effects at each timepoint will be determined. Secondary outcomes include severity of the persecutory delusion, general paranoid ideation, patient chosen therapy outcomes, and activity. Service use data and quality of life data will be collected for the health-economic evaluation. Discussion: The Feeling Safe-NL trial is the first to evaluate a treatment for people with persecutory delusions, while using mental wellbeing as the primary outcome. It will also provide the first evaluation of the combination of a peer counselling intervention and CBT-based program for recovery from persecutory delusions. Trial registration: Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022)