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临床试验/NCT01832792
NCT01832792已完成不适用

Guided Self-help for Binge Eating

Oxford Health NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
EDE-Q

研究概览

简要总结

Guided self-help (GSH) is a recommended first-step treatment for bulimia nervosa, binge eating disorder, and atypical variants of these disorders. The current study proposes to investigate the effectiveness of providing GSH either face-to-face or via e-mail, also using a delayed treatment control condition. Symptom outcomes will be assessed, and an estimate of cost-effectiveness made. Results are proposed to be disseminated locally and internationally (through submission to conferences and peer-reviewed journals), and will hopefully inform local service provision.

Please note that we are only able to offer the intervention to individuals who are currently registered with a General Practitioner that is covered by Oxford Health NHS Foundation Trust - this is typically restricted to practices in Oxfordshire, Buckinghamshire, and parts of Wiltshire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Registration with a General Practitioner covered by Oxford Health NHS Foundation Trust (typically: Oxfordshire, Buckinghamshire, parts of Wiltshire)
  • Primary diagnosis of an eating disorder with recurrent binge eating (BN, EDNOS [BN-type] or BED)
  • Age above 17.5 years (box below requires whole numbers)

排除标准

  • A severe eating disorder (e.g., one complicated by medical issues that would not be best managed by a self-help intervention)
  • BMI <18.5
  • Rapid weight loss (regardless of BMI)
  • current excessive drug use
  • active and untreated psychosis (the latter two are usually exclusion criteria to the EDS)

结局指标

主要结局

EDE-Q

时间窗: Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up

The EDE-Q is given as a measure of eating disorder symptoms in a standardised pack of measures, all given at Assessment, Start-of-treatment, End-of-treatment, and 6-month follow-up. "Assessment" concerns the patient's first contact with the Eating Disorders Service. Start-of-treatment will proceed as soon as possible; at present, the waiting list is around 3 months. Treatment lasts 12 weeks, so End-of-treatment measures will be given approximately 12 weeks after start of treatment. There is a 6-month follow-up. Binge eating is the primary outcome measure, with other eating disorder symptoms as secondary measures. Change in these symptoms will be assessed over the course of treatment.

次要结局

  • CIA(Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up)
  • CORE-OM(Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up)
  • RSES(Change in symptoms between Assessment, Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up)
  • Healthcare Use(Change in healthcare use between Start-of-treatment (approx. 3 months later), End-of-treatment (approx. 12 weeks after start of treatment), and 6-month follow-up)
  • HAq-II(End of Session 3 of treatment (3 weeks into treatment))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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