RecruitingNot ApplicableNCT07234708

Feeling Safe Study

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


Sponsor

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

Enrollment

35 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria2

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

Interventions

OTHERSentirnos 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.


Locations(1)

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Barcelona, Spain

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NCT07234708


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