A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)

Rumination Disorder Clinical Trial

Official title:

A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062696
• Other study ID #: 2017P000283
• Status: Completed
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: June 2019
• Source: Massachusetts General Hospital
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 1, 2019
• Est. primary completion date: February 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	Ani Keshishian	Boston	Massachusetts
United States	Drexel University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	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