Feeling Safe: Feasibility and Acceptability Study Evaluating a New Psychological Intervention for People With Psychosis and Positive Delusional Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Compliance related to the total number of successful appointments made
研究概览
简要总结
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.
详细描述
This is a prospective, non-randomised feasibility pilot study with a before-and-after design.
The aims of the study are:
- Assess the feasibility, acceptability, and satisfaction after receiving the Sentirnos Seguros programme in people with schizophrenia spectrum disorder and positive delusional symptoms.
- Evaluate the clinical and functional benefits and safety of the Sentirnos Seguros programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of intellectual disability
- •Meet DSM-5 criteria for other mental health disorders, except for substance-related and addictive disorders
结局指标
主要结局
Compliance related to the total number of successful appointments made
时间窗: From baseline to 6 months (end of therapy)
Compliance will be assessed by calculating the frequency of successful appointments from baseline to 6 months (end of therapy)
Number of drop-outs
时间窗: From baseline to 6 months (end of treatment)
The number of drop-outs will be assessed by calculating the proportion of participants who do not complete the study protocol
Acceptability, measured with an ad hoc questionnaire
时间窗: From baseline to 6 months (end of the treatment)
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
Satisfaction with the intervention, measured with the Client Satisfaction Questionnaire (CSQ-8)
时间窗: From baseline to 6 months (end of the treatment)
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.
次要结局
- 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 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 paranoid ideation, measured with the Spanish Green Paranoid Thought Scale (S-GPTS)(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)(Changes in baseline scores at 6 months)
- Change in quality of life, measured with the Quality of Life Index (QLI-sp)(Changes in baseline scores at 6 months)
- Change in safety behaviour severity, measured with the Safety Behaviour Questionnaire (SBQ)(Changes in baseline score at 6 months)
- Change in cognitive insight, measured with the Beck Cognitive Insight Scale (BCIS)(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 core beliefs, measured with the Brief Core Schema Scales (BSCC)(Changes in baseline scores at 6 months)
- Change in functioning severity, measured with the Personal and Social Performance scale (PSP)(Changes in baseline scores at 6 months)
- Change in recovery, measured with the Questionnaire about the Process of Recovery (QPR)(Change in baseline scores at 6 months)
- Change in clinic insight, measured with the Scale Unawareness of Mental Disorders (SUMD)(Changes in baseline scores at 6 months)
- Presence of adverse events, measured with an ad hoc clinical interview(From baseline to 6 months (end of the intervention))