Clinical Trial: A Study of Cognitive-Behavioral Therapy for Rumination Disorder

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder

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 Summary:

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.


Sponsor: Drexel University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Drexel University

Dates:
Date Received: April 10, 2017
Date Started: April 1, 2017
Date Completion: January 1, 2019
Last Updated: April 12, 2017
Last Verified: April 2017