跳至主要内容
临床试验/NCT03160092
NCT03160092Unknown不适用

Assessing the Feasibility of a Novel Intervention for Young People With At Risk Mental State and Attenuated Positive Psychotic Symptoms: The Viability of Its Use in the NHS and of a Future Trial

University of East Anglia2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年4月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms

研究概览

简要总结

Young people with At Risk Mental State (ARMS) may have changes in their thoughts and the way they see or hear things, which they might find odd and distressing. They may be feeling tense, worried and low in mood and may not feel like socialising. They may also experience difficulties with eating and sleeping. For many people these symptoms might not last for very long, but for a small number of people, they might last longer and could become worse (health professionals call this psychosis).

Psychological therapy, which involves talking to a therapist, can help to stop these symptoms from getting worse, stopping psychosis. It can also help to make the symptoms better. Cognitive Behavioural Therapy (CBT) is the treatment that is most recommended to help young people with ARMS. But, this is not always available, can take a long time and is quite expensive. Some research has shown that brief therapy with a therapist who is warm and understanding and helps the young person to make sense of their symptoms, may be as helpful as CBT, and is quicker and cheaper.

This study hopes to develop a treatment like this and to offer it to 12 young people, aged between 16 and 25, who are experiencing the symptoms outlined. Participants will be given four treatment sessions, and will be asked to complete some questionnaires. The study aims to see how they find it and whether it seems to help them. It will also ask professionals who work with these young people what they think about the new therapy. This is a feasibility study so the findings will help us to decide whether more research should be done on this treatment and whether it could be offered in the NHS in the future.

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
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 16 - 25 Years Old
  • Meeting criteria for attenuated psychosis on the Comprehensive Assessment of At Risk Mental State (CAARMS; Yung et al., 2005)
  • Has an allocated lead care professional within the Central Norfolk Youth Team
  • Identified by their care-coordinator as having capacity and being appropriate for therapy (including not being deemed at a high risk of being a danger to themselves or others).

排除标准

  • Meeting criteria for psychosis on the CAARMS and/or a previous open referral to an Early Intervention in Psychosis team
  • Change of psychiatric medication within the previous three months
  • Currently receiving psychological therapy
  • Previously had Cognitive Behavioural Therapy for At Risk Mental State

结局指标

主要结局

Comprehensive Assessment of At Risk Mental State (CAARMS) - Change in At Risk Symptoms

时间窗: 2 months

This is a 30 minute semi-structured interview, measuring the intensity, duration and frequency of subthreshold psychotic symptoms

次要结局

  • Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) - Change in psychological wellbeing(2 months)
  • Revised Short Version of the Working Alliance Inventory (WAI-SR)(2 months)
  • Session Rating Scale (SRS) - Completed after each session(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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