Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2025-07-01
2028-05-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Meet DSM-5 criteria for other mental health disorders, except for substance-related and addictive disorders
18 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Department of Psychiatry. Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIBSP-SEG-2024-186
Identifier Type: -
Identifier Source: org_study_id
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