A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder
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
- 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
