The Street Smart Group: A Feasibility Trial of a Group Intervention Targeting Anxiety Processes in Paranoia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Green Paranoid Thoughts Scale (GPTS)
研究概览
简要总结
This study aims to evaluate a novel group psychological intervention targeting anxiety triggered by urban environments for people with paranoia.
详细描述
People with a schizophrenia spectrum diagnosis often experience distressing worries or beliefs about other people intending to cause them harm (also known as paranoia). Paranoid beliefs are associated with significant distress and disruption to the person's life. This results in high use of services and costs to mental health providers.
The National Institute of Clinical Excellence recommends that cognitive behavioural therapy for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp, making it a cost effective intervention.
Although improved outcomes have been obtained by therapies, CBTp has only small to moderate effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is intensive, expensive and takes up to a year. CBTp is therefore not widely available to service users, resulting in inequalities in access to care.
The investigators are seeking to improve outcomes and accessibility of CBTp for people with distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility study of a brief therapeutic group intervention, aimed at targeting and improving anxiety processes which are causally implicated in paranoia.
The investigators have preliminary evidence indicating that the pilot intervention delivered in an individual format, with interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et al, 2014). Participants also reported they found the interventions acceptable, enjoyable and useful. Based on these results, the investigators have further developed the intervention and the current study proposes to evaluate the modified intervention delivered in a group format. A pilot randomised controlled trial (RCT) of the novel group intervention will be conducted to inform its further development and to estimate key parameters required to plan a larger trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self reported worries about being harmed or at risk from others
- •Non-affective psychosis(ICD10,F20-F29)
- •Age 18-65
- •Symptoms stable no major relapse or crisis in last 3 months prior to consent
- •Sufficient command of English to provide informed consent, complete the measures and participate in the brief interventions
- •Score above the cutoff for clinically significant levels of paranoia on the Green Paranoid Thoughts Scale (Green et al, 2008)
- •Paranoia is triggered by being outside
排除标准
- •Lack of capacity to provide informed consent
- •Primary diagnosis of drug or alcohol use with secondary psychosis
- •Primary diagnosis of mood disorder or bipolar affective disorder
- •Primary diagnosis of learning difficulty
- •Unstable residential arrangements (making a move away during the course of participation in the research likely)
结局指标
主要结局
Green Paranoid Thoughts Scale (GPTS)
时间窗: Assessed at baseline, at 6 weeks and 10 weeks
The GPTS consists of two 16-item scales. Ideas of reference (part A) and ideas of persecution (part B) are rated over the past month on a scale ranging from one (not at all) to five (totally). A total score is produced by summing all items for part A and B (minimum score = 32; maximum score = 160). A higher score indicates more paranoid thoughts.
次要结局
未报告次要终点
研究者
Dr Amy Hardy
Research Clinical Psychologist
King's College London