A Pilot Randomized Control Trial of a Relapse Prevention Online Exposure Protocol for Eating Disorders and Mechanisms of Change
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Re-admission Percentage
研究概览
简要总结
The purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over the age of 18
- •discharged from intensive treatment within the last four months (inpatient, residential, partial hospital/day program, intensive outpatient program)
- •currently meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa
排除标准
- •high and active suicidality, psychosis, mania, or medical compromised status will be excluded, as these comorbidities would make it difficult to complete study procedures
- •under the age of 18
- •does not meet criteria for anorexia nervosa, other specified feeding and eating disorder-atypical anorexia nervosa, or bulimia nervosa.
- •discharged from intensive treatment more than four months ago
结局指标
主要结局
Re-admission Percentage
时间窗: 1 Month Follow Up and 6 Month Follow Up
Using the Treatment Interview, we will assess all current and past treatment experiences, dates of treatment, and primary type of treatment. Re-admission will be assessed at follow up timepoints and defined as re-entry into a more intensive treatment setting.
Rate of Eating Disorder Relapse
时间窗: 6-Month Follow-Up
First, the investigators will define relapse as moving from one stage of remission to another (e.g., remission to partial remission or partial remission to currently ill). Second, the investigators will define relapse as re-entry into a more intensive treatment setting (e.g., moving from outpatient to partial hospitalization).
Change in Eating Disorder Symptoms using the EDE-Q
时间窗: Up to 6-Month Follow-Up
The Eating Disorder Examination Questionnaire (EDEQ), a self-reported measure, is assessed at multiple time points throughout the duration of the study and is used to examine the attitudes and behaviors in individuals with eating disorder symptoms.
次要结局
- Change in Positive and Negative Affect(Treatment Session 2 through 5)
- Fear Extinction(Up to 6 Month Follow Up)
- Change in Eating Disorder Symptoms(Treatment Session 2 through 5)
- Change in State Anxiety(Treatment Session 1 through 5)
- Change in State Fear of Food(Treatment Session 2 through 5)
研究者
Cheri Levinson
Director
University of Louisville