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临床试验/NCT03934697
NCT03934697已完成不适用

In-Vivo Treatment for Imaginal Exposure Therapy

University of Louisville2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017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
43
试验地点
2
主要终点
EDEQ (Eating Disorder Examination Questionnaire) at 1-10 Weeks and at 1 year

研究概览

简要总结

The purpose of this study is to test if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety.

详细描述

An initial meeting consisting of a screening, questionnaires, and a brief psychoeducation on imaginal exposure therapy, followed by 8-10 sessions with a licensed psychologist (the PI) or a clinical psychology graduate student who is supervised and trained by the PI. In Session 1, patients will create a script with the therapist on an eating disorder fear. In sessions 2-10 the therapist and patient will then imagine this eating disorder related fear based on the script. Each session will be modified to focus on "hot spots" or the most feared aspect of the script. Sessions will be audiotaped and videotaped and participants will be asked to listen to the sessions nightly for homework. Sessions will be weekly or twice per week for 8-10 weeks after the initial screening session.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be at least 18 years of age (no age limit)
  • Must currently meet criteria for anorexia, sub-clinical anorexia, bulimia, or sub-clinical bulimia (using the eating disorder diagnostic scale), OR have met criteria for one of these eating disorders in the last year, OR endorse significant eating disorder fears
  • Must have at least one significant eating disorder related fear.

排除标准

  • Under 18 years of age
  • Individuals who have binge eating disorder or an unspecified eating disorder, OR who do not meet eating disorder related criteria
  • Individuals who meet criteria for mania, psychosis, or suicidal ideation
  • Participants who are not able to secure transportation to complete therapy sessions

结局指标

主要结局

EDEQ (Eating Disorder Examination Questionnaire) at 1-10 Weeks and at 1 year

时间窗: 1 year and 10 weeks

The EDE-Q is a 41-item self-report questionnaire version of the Eating Disorder Examination, which is a semi-structured interview designed to assess eating disorders symptom frequency and severity over the past 28 days. The EDE-Q uses a 7-point forced-choice rating scheme (No days; 1-5 days; 6-12 days; 13-15 days; 16-22 days; 23-27 days; Everyday). The EDE-Q has four subscales with the question stem "How many days out of the past 28 days...": Restraint (e.g. Have you been consciously trying to restrict the amount of food you eat to influence your shape or weight?), Eating Concern (e.g. Have you had a definite fear that you might not be able to either resist eating or stop eating?), Weight Concern (e.g. Has your weight influenced how you think about (judge) yourself as a person?), and Shape Concern (e.g. How dissatisfied have you felt about your shape?).

SUDS (Subjective Units of Distress Scale) at 1-10 Weeks and at 1 year

时间窗: 1 year and 10 weeks

The SUDS scale is a self-report behavioral measure used during exposure treatment and behavioral assessment to measure anxiety. The SUDS scale has been shown to be a valid and reliable measure of state anxiety. SUDS ratings can range from 0 (completely calm) to 100 (highest anxiety). Other reference points used in this study include 25 (noticeable, but not bothersome anxiety), 50 (bothersome anxiety), and 75 (very bothersome anxiety). Subjective anxiety was assessed both in terms of categorical response and overall change. Categorical response was defined as a drop of at least five points in average SUDS across the exposure across visits.

Body Mass Index (BMI) at 1-10 Weeks and at 1 year

时间窗: 1 year and 10 weeks

Participants will be weighed at 1-10 Weeks and at 1 year and BMI will be calculated in order to see if the BMI of an individual has changed over time.

次要结局

未报告次要终点

研究者

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

Cheri Levinson

Asst Professor

University of Louisville

研究点 (2)

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