- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113682
A Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)
Time Frame: Change from baseline to 3-month follow-up
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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.
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Change from baseline to 3-month follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1702005190
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Massachusetts General HospitalDrexel UniversityCompletedRumination DisorderUnited States
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Erasmus Medical CenterCompletedMajor Depression | Anxiety DisorderNetherlands
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University of TehranStanford UniversityCompletedBipolar Depression | Major Depressive DisorderIran, Islamic Republic of
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Columbia UniversityNational Institute of Mental Health (NIMH)Not yet recruitingRumination | Depression in AdolescenceUnited States
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Institute of Automation, Chinese Academy of SciencesRecruiting
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