Testing the combination of Feeling Safe and peer counselling against formulation-based cognitive behaviour therapy to promote psychological wellbeing in people with persecutory delusions: study protocol for a randomized controlled trial (the Feeling Safe-NL Trial).

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-behaviour 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 the 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 a CBT-based program for recovery from persecutory delusions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25766661 (retrospectively registered 7 July 2022).

Health-economic benefits of treating trauma in psychosis.

Background: Co-occurrence of posttraumatic stress disorder (PTSD) in psychosis (estimated as 12%) raises personal suffering and societal costs. Health-economic studies on PTSD treatments in patients with a diagnosis of a psychotic disorder have not yet been conducted, but are needed for guideline development and implementation. This study aims to analyse the cost-effectiveness of guideline PTSD therapies in patients with a psychotic disorder. Methods: This health-economic evaluation alongside a randomized controlled trial included 155 patients with a psychotic disorder in care as usual (CAU), with comorbid PTSD. Participants received eye movement desensitization and reprocessing (EMDR) (n = 55), prolonged exposure (PE) (n = 53) or waiting list (WL) (n = 47) with masked assessments at baseline (T0) and at the two-month (post-treatment, T2) and six-month follow-up (T6). Costs were calculated using the TiC-P interview for assessing healthcare consumption and productivity losses. Incremental cost-effectiveness ratios and economic acceptability were calculated for quality-adjusted life years (EQ-5D-3L-based QALYs) and PTSD 'Loss of diagnosis' (LoD, CAPS). Results: Compared to WL, costs were lower in EMDR (-€1410) and PE (-€501) per patient per six months. In addition, EMDR (robust SE 0.024, t = 2.14, p = .035) and PE (robust SE 0.024, t = 2.14, p = .035) yielded a 0.052 and 0.051 incremental QALY gain, respectively, as well as 26% greater probability for LoD following EMDR (robust SE = 0.096, z = 2.66, p = .008) and 22% following PE (robust SE 0.098, z = 2.28, p = .023). Acceptability curves indicate high probabilities of PTSD treatments being the better economic choice. Sensitivity analyses corroborated these outcomes. Conclusion: Adding PTSD treatment to CAU for individuals with psychosis and PTSD seem to yield better health and less PTSD at lower costs, which argues for implementation.

Antecedentes: La comorbilidad de TEPT en la psicosis (estimada en 12%) aumenta el sufrimiento personal y los costos para la sociedad. No se han realizado aún estudios de economía de la salud de los tratamientos de TEPT en pacientes con diagnóstico de un trastorno psicótico, pero son necesarios para el desarrollo e implementación de guías. Este estudio apunta a analizar la costo-efectividad de las terapias para TEPT con guías clínicas en pacientes con un trastorno psicótico.Métodos: Esta evaluación de economía de la salud asociada a un estudio randomizado controlado incluyó a 155 pacientes con un trastorno psicótico en cuidado habitual (CAU), con TEPT comórbido.Los pacientes recibieron terapia de reprocesamiento por movimientos oculares (EMDR, n=55), exposición prolongada (PE, n=53) o lista de espera (WL, n=47) con evaluaciones ciegas basal (T0), a los 2 meses (post-tratamiento, T2) y a los 6 meses de seguimiento (T6). Los costos fueron calculados usando la entrevista TiC-P para evaluar el consumo en los sistemas de salud y pérdidas de productividad. Las tasas incrementales de costo-efectividad y acepabilidad económica fueron calculadas por Años de Vida ajustados por calidad (QALY basado en EQ-5D-3L) y pérdida de diagnóstico de TEPT (LoD, CAPS)Resultados: En comparación a lista de espera, los costos fueron menores en EMDR (-€1410) y PE (-€501) por paciente por cada 6 meses. Además, EMDR (SE robusta 0.024, t=2.14, p=0.035) y PE (SE robusta 0.024, t=2.14, p=0.035) produjeron una ganancia incremental en QALY de 0.05 y una probabilidad 26% mayor de LoD luego de EMDR (SE robusta 0.096, z=2.66, p=0.008) y 22% luego de PE (SE robusta 0.098, z=2.28, p=0.023). Las curvas de aceptabilidad indican altas probabilidades de que los tratamientos para TEPT sean la mejor alternativa económica. Los análisis de sensibilidad corroboraron estos resultados.Conclusion: El agregar tratamiento para TEPT a los cuidados habituales en pacientes con psicosis y TEPT parece producir mejor salud y menos TEPT a menor costo, lo que aboga por su implementación.