A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 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 characterized by the repeated regurgitation of food during or soon after eating, which typically occurs at least a few times per week, frequently daily, with subsequent re-chewing, re-swallowing, or spitting out of the regurgitated material. Diaphragmatic breathing is a widely used technique for rumination as a competing response to the abdominal wall contraction hypothesized to trigger regurgitation. However, the efficacy of diaphragmatic breathing remains unknown and has mainly been delivered simply through a one-session instruction with an occasional follow-up.
In the absence of evidence-based treatments for RD, Dr. Jennifer Thomas has contributed to the creation of a manualized treatment, Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD) informed by published case reports and currently in use at the Eating Disorders Clinical and Research Program (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
- 否
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)
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
Jennifer Thomas
Co-Director, Eating Disorders Clinical and Research Program
Massachusetts General Hospital
