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Clinical Trials in Spain / NCT07234708
Recruiting Not applicable

Feeling Safe Study

NCT07234708 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Phase
Not applicable
Started
2025-07-01
Last updated
2025-11-21

Condition(s) studied

Schizophrenia and Schizophrenia Spectrum Psychosis

Investigational drug(s) / intervention(s)

Sentirnos Seguros

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Compliance related to the total number of successful appointments made — From baseline to 6 months (end of therapy)
    Compliance will be assessed by calculating the frequency of successful appointments from baseline to 6 months (end of therapy)
  • Number of drop-outs — From baseline to 6 months (end of treatment)
    The number of drop-outs will be assessed by calculating the proportion of participants who do not complete the study protocol
  • Acceptability, measured with an ad hoc questionnaire — From baseline to 6 months (end of the treatment)
    Acceptability with the intervention will be assessed by an ad hoc questionnaire to measure the dimensions of acceptability: perceived utility, perceived ease of use, barriers, and intention to use
  • Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire (CSQ-8) — From baseline to 6 months (end of the treatment)
    Satisfaction with the intervention will be assessed using the CSQ-8. A 4-point Likert scale is used to rate each item (1 = very dissatisfied; 4 = very satisfied), yielding a total score ranging from 8 to 32. A low score (close to 8) indicates low satisfaction with the services received, and a high score (close to 32) indicates high satisfaction with them.

Trial sites (1)

FacilityCityRegionStatus
Department of Psychiatry. Hospital Santa Creu i Sant Pau Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07234708 on ClinicalTrials.gov ↗ ← All trials in Spain