CClinicalTrials.gg
Status unknownNCT03113682CBT-RDUpdated Sep 28, 2018

A Study of Cognitive-Behavioral Therapy for Rumination Disorder

An interventional study of CBT-RD in Rumination Disorder, sponsored by Drexel University. Status unknown at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Drexel University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
10 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

03

In context

Rumination Syndrome

72 studies on the registry are indexed under Rumination Syndrome; 22 are open to participants now.

This study's enrollment of 7 is below the median of 62 across 63 interventional studies indexed under Rumination Syndrome.

Browse Rumination Syndrome studies →

Lead sponsor

Drexel University is the lead sponsor of 110 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • 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.

    Behavioral: CBT-RD

Interventions

  • BehavioralCBT-RD

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline to 3-month follow-up

07

Study locations

1 site
  • Drexel University
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03113682
Lead sponsor
Drexel University
Responsible party
Sponsor
First posted
Apr 13, 2017
Start date
Apr 1, 2017
Primary completion
Jan 1, 2019 (estimated)
Completion
Jan 1, 2019 (estimated)
Last update
Sep 28, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion