A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
Primary Purpose
Rumination Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT-RD
Sponsored by
About this trial
This is an interventional treatment trial for Rumination Disorder
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
Sites / Locations
- Ani Keshishian
- Drexel University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention (CBT-RD)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03062696
First Posted
February 20, 2017
Last Updated
June 14, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Drexel University
1. Study Identification
Unique Protocol Identification Number
NCT03062696
Brief Title
A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
Official Title
A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Drexel University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rumination Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (CBT-RD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT-RD
Intervention Description
5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.
Primary Outcome Measure Information:
Title
Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)
Description
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.
Time Frame
Change from baseline to 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer J Thomas, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ani Keshishian
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder (CBT-RD)
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