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临床试验/NCT03113682
NCT03113682Unknown不适用

A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder

Drexel University2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
7
试验地点
2
主要终点
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)

研究概览

简要总结

The primary aim of this study is to pilot cognitive behavioral therapy (CBT-RD) for 10 individuals ages 10 and older who have rumination disorder

详细描述

Rumination disorder (RD; also known as "rumination syndrome") is a disordered eating behavior characterized by the repeated regurgitation of food during or soon after eating. The frequency of repeated regurgitation of food typically occurs at least a few times per week, frequently daily with subsequent re-chewing, re-swallowing, or spitting out of the regurgitated material. The widely used technique for treatment of RD has typically been diaphragmatic breathing, which works by serving as a competing response to abdominal wall contractions, which is hypothesized to trigger regurgitation. However, the efficacy of diaphragmatic breathing remains unknown and has mainly been delivered through a one-session instruction with an occasional follow-up.

In the absence of evidence-based treatments for RD, the investigators, alongside a collaboration with Dr. Jennifer Thomas at the Eating Disorders Clinical and Research Program (EDCRP) at Massachusetts General Hospital, have created a manualized treatment, Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD) informed by published case reports and currently in use at EDCRP at Massachusetts General Hospital and the Psychological Services Center at Drexel University. CBT-RD targets the habitual contraction of the abdominal wall and preceding events through the use of habit reversal, using primarily diaphragmatic breathing as a competing response.

This study involves a phone screen to determine eligibility, followed by 5-8 sessions of CBT-RD (approximately 50 minutes each). A battery of questionnaires will be administered at pre-treatment, post-treatment, and 3-month follow-up intervals.

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

入选标准

  • Age 10 or above
  • Experience repeated regurgitation of food during or soon after eating, consistent with rumination disorder
  • If applicable, have stable psychiatric medication for the past three months

排除标准

  • Currently engage (in past three months) in any regular compensatory behaviors (e.g., self-induced vomiting, laxative/diuretic use)
  • Current diagnosis of anorexia nervosa
  • Acute suicide risk
  • Are currently receiving psychological treatment for rumination disorder
  • Co-morbid clinically significant psychological disorder that would require attention beyond the study treatment (e.g., psychotic disorder, substance dependence)
  • Current pregnancy

研究组 & 干预措施

Intervention (CBT-RD)

Experimental

There is only one arm in this study - all participants will be in the same arm, as all participants will receive CBT-RD. There is no control group.

干预措施: CBT-RD (Behavioral)

结局指标

主要结局

Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)

时间窗: Change from baseline to 3-month follow-up

A semi-structured interview to assess pica, Avoidant/Restrictive Food Intake Disorder (ARFID), and/or rumination disorder diagnosis, severity, and symptoms. We will use the PARDI to assess frequency and severity of rumination behavior specifically.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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