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临床试验/NCT01517906
NCT01517906已完成不适用

Developing Identity: An Eating Disorder Nursing Therapy

University of Michigan2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2002年4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
69
试验地点
2
主要终点
Eating Disorder Interview

研究概览

简要总结

The purpose of this research study is to test a new type of counseling developed to decrease symptoms of anorexia nervosa and bulimia nervosa and improve health and well-being in women with these eating disorders. At this time, the most effective form of treatment for anorexia nervosa and bulimia nervosa is cognitive behavioral therapy. However, this form of treatment leads to a complete absence of symptoms in only about 50% of persons completing the treatment program. In this study we will test the effectiveness of a new form of counseling that focuses on identifying and building personal strengths and positive views of the self as the means to decrease eating disorder symptoms and improve health. This study will involve 150 women between the ages of 18 and 35 years who currently have symptoms of anorexia nervosa or bulimia nervosa. To participate in this study, women must also be: 1) not pregnant, 2) without any other diagnosable mental disorder, 3) not currently taking medications for their eating disorder or other mental disorder symptoms, 4) not ill enough to require inpatient treatment for their eating disorder and 5) willing to refrain from seeking other treatment for their eating disorder for the duration of this study. Each participant will participate in a 20-week treatment program that includes nutritional counseling and medical care. Both of these forms of treatment are considered by the American Psychiatric Association to be essential parts of treatment for eating disorders and have been found help to reduce symptoms. In addition, participants will receive one of two types of counseling:

  1. Experimental counseling that focuses on building strengths and positive self-views
  2. Standard counseling that helps the participant identify and solve problems that are believed to contribute to their eating disorder symptoms.

The type of counseling that a participant receives will be determined randomly. To determine whether the experimental counseling is effective, eating disorder symptoms, psychological and functional health will be measured before the treatment begins and three times after the treatment ends (immediately after treatment ends, 6 and 12 months later). The findings of this research study are expected to contribute to the development of effective interventions to decrease eating disorder symptoms, and increase health and well-being in women with anorexia nervosa and bulimia nervosa.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Anorexia nervosa
  • Subthreshold anorexia nervosa
  • Bulimia nervosa
  • Subthreshold Bulimia nervosa
  • Nonpregnant
  • No prescribed psychotropic medication
  • No concurrent psychiatric treatment
  • No indications for inpatient treatment including suicide risk, significant metabolic or cardiac complications
  • Willingness to refrain from seeking other forms of ED treatment until completing the intervention and post-treatment data collection protocols
  • Negative lifetime history for schizophrenia, other DSM-IV Axis I psychotic disorders and mental retardation

排除标准

  • Acute and chronic medical conditions other than those related to the ED
  • Any other concurrent DSM-IV Axis I disorder at threshold level

结局指标

主要结局

Eating Disorder Interview

时间窗: Change from baseline to 12 months post-intervention

A computerized menu-driven interview will be used to prospectively measure ED behaviors (event-triggered EMA methodology).

Eating Disorder Inventory

时间窗: Change from baseline to 12 mos post-intervention

A self-report measure of the ED attitudes associated with AN and BN that is widely used as an outcome measure in intervention studies. The inventory consists of 64 items that are used to generate eight subscale scores. In this study, the drive for thinness, body dissatisfaction and bulimia subscale scores will be used

次要结局

  • Psychological Well-Being Scale(Baseline, immediate, 6, 12 m post-intervention)
  • SF-36 Survey(Baseline, immediate, 6 and 12 m post-intervention)

研究者

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

Karen Farchaus Stein

Professor of Nursing

University of Michigan

研究点 (2)

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