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临床试验/NCT05746364
NCT05746364已完成不适用

Case-Series Examination of a Brief CAT-Informed Intervention for Young People Experiencing Difficulties With Eating (RIDE)

University of Manchester2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Retention rate of participants at all five intervention sessions

研究概览

简要总结

Eating Disorders (ED) are mental health conditions where people alter food intake in some way to help with weight gain, managing emotions or other situations. EDs are increasingly common in young people. They can cause both the young person and those around them significant distress. Talking therapies can help.

Cognitive Analytic Therapy (CAT) is a talking therapy that is becoming increasingly widely used within the NHS to help with a wide range of problems. CAT focuses on the relationships clients have with themselves and others around them. From CAT, we have developed Relational Intervention for Difficulties with Eating (RIDE), This is a brief talking therapy. The aim is to help the young person and those around them build an understanding of their difficulties. This will hopefully mean others can support them with their disordered eating.

The aim of the study is to examine the feasibility (is it possible to conduct a study about this intervention?) and acceptability (do participants find the therapy is helpful and makes sense to them?) of RIDE. As a secondary aim, the study will look at whether RIDE shows preliminary evidence for positive change on relevant measures of psychological difficulties (e.g. distress, how young people feel about themselves and others).

The study will aim to recruit nine young people (aged between 14-25) with ED. Participants must be under the care of an ED service. They will attend 8 appointments (3 assessment, 5 therapy) either at their home, University of Manchester campus or a health service clinic. A video conferencing platform (e.g. Zoom, Teams) can be used if required. Participants will complete questionnaires before, during and after therapy.

The findings will help to develop the therapy and improve further testing in larger studies. If successful, RIDE could be available as a treatment for young people.

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

入选标准

  • Participants will be between the ages of 14 - 25 years.
  • Participants will be under the care of a mental health team and have a clinician allocated to them within local ED Services.

排除标准

  • Young people will be excluded if they are currently receiving alternative one-to-one psychological therapy (not including family interventions or skill-based groups).
  • Young people will be excluded if they have a moderate to severe intellectual disability which would impair their ability to participate without considerable adaptations being made to the intervention, as judged by the young person or the clinical team.
  • Young people will be excluded if they have inadequate English-language speaking skills due to limitations in their ability to engage with talking therapies in the English language.
  • Young people will be excluded if they are judged at high risk of harm to themselves, operationalised as having current suicidal thoughts with a high intent or active plan to end their life. This includes individuals who are deemed at risk of harm to themselves by the clinical team due to a sustained trajectory of recent weight loss.

结局指标

主要结局

Retention rate of participants at all five intervention sessions

时间窗: 12 months

At least 70% of those recruited will attend all 5 intervention sessions.

Proportion of missing data across outcome assessments

时间窗: 12 months

The level of missing data on clinical outcome measures at assessments (for those still retained in the study) does not exceed 20% per assessment

Number of eligible referrals that consent to participate

时间窗: 12 months

Over 50% of those who are referred to the study and are eligible to participate, will consent to take part in the study.

Adapted Experiences of Services Questionnaire

时间窗: post-treatment (8 weeks).

Adapted Experiences of Services Questionnaire measures satisfaction with experiences of therapy and will be used to gain feedback and measure aspects of the acceptability of the intervention. Seven items are rated on 0 to 3 scale, With higher item scores indicating greater satisfaction with therapy.

次要结局

  • Recovery Questionnaire (ReQuest-YP)(post-treatment (8 weeks). Follow-up (10 weeks))
  • The Young Person's Clinical Outcome in Routine Evaluation (YP-CORE)(post-treatment (8 weeks). Follow-up (10 weeks))
  • University of Rode Island Change Assessment Scale (URICA)(post-treatment (8 weeks). Follow-up (10 weeks))
  • Repertory grid(post-treatment (8 weeks))
  • The Eating Disorder Examination Questionnaire (EDE-Q)(post-treatment (8 weeks).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Taylor

Senior clinical lecturer

University of Manchester

研究点 (2)

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