Skip to main content
Clinical Trials/NCT03113682
NCT03113682
Unknown
N/A

A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder

Drexel University1 site in 1 country7 target enrollmentApril 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rumination Disorder
Sponsor
Drexel University
Enrollment
7
Locations
1
Primary Endpoint
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)
Last Updated
7 years ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
January 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials