NCT07234708

Feeling Safe Study

Feeling Safe: Feasibility and Acceptability Study Evaluating a New Psychological Intervention for People With Psychosis and Positive Delusional Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to assess the acceptability and satisfaction with the psychological intervention Sentirnos Seguros (Feeling Safe) in people with psychotic disorders and positive delusional symptoms. The main questions it aims to answer are: * Study participants will report high levels of acceptability and satisfaction with the Sentirnos Seguros programme. * The Sentirnos Seguros intervention will be beneficial for participants at a clinical and functional level, with higher scores in the post-treatment phase compared to the pre-treatment phase.

Detailed description

This is a prospective, non-randomised feasibility pilot study with a before-and-after design. The aims of the study are: 1. Assess the feasibility, acceptability, and satisfaction after receiving the Sentirnos Seguros programme in people with schizophrenia spectrum disorder and positive delusional symptoms. 2. Evaluate the clinical and functional benefits and safety of the Sentirnos Seguros programme.

Conditions

• Schizophrenia and Schizophrenia Spectrum Psychosis

Interventions

Type	Name	Description
OTHER	Sentirnos Seguros	The Sentirnos Seguros (Feeling Safe) programme is modular, personalised and includes the patient's preferences. The following modules are offered: improving sleep, reducing worry, increasing self-confidence, reducing the impact of voices, and feeling safe enough.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-03-01
• Completion: 2028-05-01
• First posted: 2025-11-18
• Last updated: 2025-11-21

Locations

1 site across 1 country: Spain