Feeling Safe Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sentirnos Seguros.
- Who it may be relevant to
- Registry conditions: Schizophrenia and Schizophrenia Spectrum Psychosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feeling Safe: Feasibility and Acceptability Study Evaluating a New Psychological Intervention for People With Psychosis and Positive Delusional Symptoms
Overview
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.
Detailed description
This is a prospective, non-randomised feasibility pilot study with a before-and-after design.
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.
Interventions
- Other 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.
Primary outcome measures
- Compliance related to the total number of successful appointments made [Time frame: From baseline to 6 months (end of therapy)]
- Number of drop-outs [Time frame: From baseline to 6 months (end of treatment)]
- Acceptability, measured with an ad hoc questionnaire [Time frame: From baseline to 6 months (end of the treatment)]
- Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire (CSQ-8) [Time frame: From baseline to 6 months (end of the treatment)]
Secondary outcome measures (12)
- Change in the severity of psychotic symptoms, measured with the Positive and Negative Syndrome Scale (PANSS) [Time frame: Changes in baseline scores at 6 months]
- Change in severity of hallucinations and delusions, measured with the Psychotic Symptom Rating Scales (PSYRATS) [Time frame: Changes in baseline scores at 6 months]
- Change in depression severity, measured with the Calgary Depresión Scale for Schizophrenia (CDSS) [Time frame: Changes in baseline scores at 6 months]
- Change in the delusional conviction severity measured with the delusional conviction-analogue visual scale (DC-VAS) [Time frame: Changes in baseline scores at 6 months]
- Change in core beliefs, measured with the Brief Core Schema Scales (BSCC) [Time frame: Changes in baseline scores at 6 months]
- Change in safety behaviour severity, measured with the Safety Behaviour Questionnaire (SBQ) [Time frame: Changes in baseline score at 6 months]
- Change in paranoid ideation, measured with the Spanish Green Paranoid Thought Scale (S-GPTS) [Time frame: Changes in baseline scores at 6 months]
- Change in functioning severity, measured with the Personal and Social Performance scale (PSP) [Time frame: Changes in baseline scores at 6 months]
- Change in self-perceived functionality severity, measured with the Self-perceived Functionality in people with Psychotic disorders (FAP-10) [Time frame: Changes in baseline scores at 6 months]
- Change in quality of life, measured with the Quality of Life Index (QLI-sp) [Time frame: Changes in baseline scores at 6 months]
- Change in recovery, measured with the Questionnaire about the Process of Recovery (QPR) [Time frame: Change in baseline scores at 6 months]
- Change in clinic insight, measured with the Scale Unawareness of Mental Disorders (SUMD) [Time frame: Changes in baseline scores at 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Department of Psychiatry. Hospital Santa Creu i Sant Pau — Barcelona
Identifiers
NCT: NCT07234708 · IIBSP-SEG-2024-186