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

NCT ID: NCT03062696

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2019-02-01

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.

Conditions

Rumination Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CBT-RD

Intervention Type: BEHAVIORAL

5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.

Interventions

CBT-RD

5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Drexel University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Thomas

Co-Director, Eating Disorders Clinical and Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer J Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Ani Keshishian

Boston, Massachusetts, United States

Drexel University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2017P000283

Identifier Type: -

Identifier Source: org_study_id