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Идёт набор NCT07234708

Feeling Safe Study

Без фазы С лечением Schizophrenia and Schizophrenia Spectrum Psychosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sentirnos Seguros.
Кому может быть актуально
Состояния в реестре: Schizophrenia and Schizophrenia Spectrum Psychosis. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
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Официальное название

Feeling Safe: Feasibility and Acceptability Study Evaluating a New Psychological Intervention for People With Psychosis and Positive Delusional Symptoms

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Compliance related to the total number of successful appointments made [Срок оценки: From baseline to 6 months (end of therapy)]
  • Number of drop-outs [Срок оценки: From baseline to 6 months (end of treatment)]
  • Acceptability, measured with an ad hoc questionnaire [Срок оценки: From baseline to 6 months (end of the treatment)]
  • Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: From baseline to 6 months (end of the treatment)]
Вторичные конечные точки (12)
  • Change in the severity of psychotic symptoms, measured with the Positive and Negative Syndrome Scale (PANSS) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in severity of hallucinations and delusions, measured with the Psychotic Symptom Rating Scales (PSYRATS) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in depression severity, measured with the Calgary Depresión Scale for Schizophrenia (CDSS) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in the delusional conviction severity measured with the delusional conviction-analogue visual scale (DC-VAS) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in core beliefs, measured with the Brief Core Schema Scales (BSCC) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in safety behaviour severity, measured with the Safety Behaviour Questionnaire (SBQ) [Срок оценки: Changes in baseline score at 6 months]
  • Change in paranoid ideation, measured with the Spanish Green Paranoid Thought Scale (S-GPTS) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in functioning severity, measured with the Personal and Social Performance scale (PSP) [Срок оценки: 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) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in quality of life, measured with the Quality of Life Index (QLI-sp) [Срок оценки: Changes in baseline scores at 6 months]
  • Change in recovery, measured with the Questionnaire about the Process of Recovery (QPR) [Срок оценки: Change in baseline scores at 6 months]
  • Change in clinic insight, measured with the Scale Unawareness of Mental Disorders (SUMD) [Срок оценки: Changes in baseline scores at 6 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Department of Psychiatry. Hospital Santa Creu i Sant Pau — Barcelona

Идентификаторы

NCT: NCT07234708 · IIBSP-SEG-2024-186

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗