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Completed

NCT Number: NCT03062696

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

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

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ani Keshishian, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT-RD

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Drexel University

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2017
Registry last updated
Jun 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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