Feeling Safe Study

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Enrolling

Conditions: Schizophrenia and Schizophrenia Spectrum Psychosis

Treatments: Other: Sentirnos Seguros

Study type: Interventional

Funder types: Other

Identifiers

NCT07234708

IIBSP-SEG-2024-186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged 18 years and older
• Diagnosis of schizophrenia spectrum disorders and other psychotic disorders according to DSM-5
• Score ≥ 4 on the delusions item of the Positive and Negative Syndrome Scale (PANSS)
• Presence of ideas of persecution with a degree of conviction > 60% in the last 3 months

Exclusion criteria

• Presence of intellectual disability
• Meet DSM-5 criteria for other mental health disorders, except for substance-related and addictive disorders

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Intervention

Experimental group

Treatment:

Other: Sentirnos Seguros