Feeling Safe (Sentirnos Seguros) psychological programme for people with schizophrenia and persecutory delusions
Feeling Safe: Feasibility and Acceptability Study Evaluating a New Psychological Intervention for People With Psychosis and Positive Delusional Symptoms
This pilot will try the Sentirnos Seguros (Feeling Safe) therapy with adults who have schizophrenia-spectrum disorders and persecutory delusions to see if they find it acceptable and experience clinical and functional improvement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT07234708 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomised feasibility pilot using a before-and-after design to measure acceptability, satisfaction, clinical outcomes, functional change, and safety following the Sentirnos Seguros intervention. Adults with DSM-5 schizophrenia-spectrum or other psychotic disorders who score ≥4 on the PANSS delusions item and report persecutory beliefs with >60% conviction are enrolled at Hospital Santa Creu i Sant Pau in Barcelona. Participants receive the Sentirnos Seguros psychological programme and are assessed before and after treatment on acceptability, satisfaction, symptom scales, functional measures, and safety. There is no control group; the primary aim is to establish feasibility and preliminary signals of benefit to inform larger controlled trials.
Who should consider this trial
Good fit: Adults (18+) with a DSM-5 schizophrenia-spectrum or other psychotic disorder who currently have persecutory delusions (PANSS delusions ≥4 and conviction >60%) are the intended participants.
Not a fit: People with intellectual disability, those with a primary DSM-5 diagnosis other than schizophrenia-spectrum psychosis (except substance-related disorders), or those without prominent persecutory delusions are unlikely to benefit from this programme.
Why it matters
Potential benefit: If successful, the programme could provide an acceptable, culturally adapted psychological option that reduces persecutory delusions and improves daily functioning for patients.
How similar studies have performed: The original Feeling Safe programme has demonstrated benefits for persecutory delusions in prior controlled trials, so this study adapts and tests an approach with existing positive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Barcelona
- Department of Psychiatry. Hospital Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Eva Grasa, PhD Psychologist
- Email: egrasa@santpau.cat
- Phone: +34 93 553 78 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.