Feeling Safe Study

NCT07234708 | Recruiting DMC

• 1 other identifier: IIBSP-SEG-2024-186
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia and Schizophrenia Spectrum Psychosis

Keywords

Feeling Safe; Schizophrenia; Acceptability; Feasibility

Outcome Measures

Primary Outcomes (4)

• Compliance related to the total number of successful appointments made

  Compliance will be assessed by calculating the frequency of successful appointments from baseline to 6 months (end of therapy)

  From baseline to 6 months (end of therapy)

• Number of drop-outs

  The number of drop-outs will be assessed by calculating the proportion of participants who do not complete the study protocol

  From baseline to 6 months (end of treatment)

• Acceptability, measured with an ad hoc questionnaire

  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

  From baseline to 6 months (end of the treatment)

• Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire (CSQ-8)

  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.

  From baseline to 6 months (end of the treatment)

Secondary Outcomes (14)

• Change in the severity of psychotic symptoms, measured with the Positive and Negative Syndrome Scale (PANSS)

  Changes in baseline scores at 6 months

• Change in severity of hallucinations and delusions, measured with the Psychotic Symptom Rating Scales (PSYRATS)

  Changes in baseline scores at 6 months

• Change in depression severity, measured with the Calgary Depresión Scale for Schizophrenia (CDSS)

  Changes in baseline scores at 6 months

• Change in the delusional conviction severity measured with the delusional conviction-analogue visual scale (DC-VAS)

  Changes in baseline scores at 6 months

• Change in core beliefs, measured with the Brief Core Schema Scales (BSCC)

  Changes in baseline scores at 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Other: Sentirnos Seguros

Interventions

Sentirnos Seguros OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Eva Grasa, PhD Psychologist

CONTACT

+34 93 553 78 40; egrasa@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: November 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)