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临床试验/NCT01174602
NCT01174602已完成不适用

Randomized Controlled Trial of Inpatient Exposure Therapy and Response Prevention for Anorexia Nervosa

New York State Psychiatric Institute1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年11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
40
试验地点
1
主要终点
Eating Behavior

研究概览

简要总结

Exposure and response prevention (AN-EXRP) will help individuals with anorexia nervosa improve their eating behavior.

详细描述

Anorexia nervosa (AN) is a serious illness associated with substantial morbidity and a mortality rate among the highest of any psychiatric illness. The rate of relapse is disturbingly high, with up to 50% of patients requiring re-hospitalization within a year of discharge. Current treatments are inadequate in helping older adolescents and adults achieve sustained recovery. Importantly, eating behavior remains disturbed after weight restoration: patients demonstrate restrictive eating in their self-selected foods and in standardized meals, and caloric intake in standardized meals is inversely related to pre-meal anxiety. Emerging data suggest that eating behavior is particularly important in post-hospital course, and that significantly altering eating behavior is critical in improving outcome for these individuals. Furthermore, caloric intake in standardized meals has been shown to be related to pre-meal anxiety. This study evaluates the potential utility of two psychotherapeutic interventions in improving eating behavior prior to hospital discharge. Each individual receives, in random order, Cognitive Remediation Therapy for 4 weeks and Exposure and Response Prevention for AN for 4 weeks. The investigators hypothesize that these interventions will lead to improvement in eating behavior, measured by food diaries and standardized meals.

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
16 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV-TR™ diagnosis of anorexia nervosa (restricting or binge-purge subtype), with or without amenorrhea at the time of inpatient admission
  • Subjects will have achieved 85% of ideal body weight (IBW)
  • Age 16-45 years
  • No acute medical condition
  • Subjects must have signed informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

排除标准

  • Psychotic or bipolar I disorder
  • Substance abuse or dependence in the last 6 months
  • Current Axis I disorder requiring psychotropic medication (ongoing antidepressant treatment for stable comorbid conditions will be allowed)
  • Significant co-morbid depression
  • Significant medical problems that would introduce additional risk related to research or interfere with participation, e.g. SBP>140, DBP>90, HR>100 for a sustained period.
  • Active suicidal intent

结局指标

主要结局

Eating Behavior

时间窗: 4 weeks

Eating behavior will be measured as both intake patterns in food records and in a laboratory based meal.

次要结局

  • Psychological Improvement(8 weeks)
  • Eating Behavior(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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