A Study of Cognitive-Behavioral Therapy for Rumination Disorder

Rumination Disorder Clinical Trial

— CBT-RD  

Official title:

A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113682
• Other study ID #: 1702005190
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2018
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Disease
• Feeding and Eating Disorders of Childhood
• Rumination Disorder

Intervention

Behavioral:
• CBT-RD
5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.

Locations

Country	Name	City	State
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)	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.	Change from baseline to 3-month follow-up