Clinical trial NCT03113682: A Study of Cognitive-Behavioral Therapy for Rumination Disorder
Official title: A Pilot Study of Cognitive-Behavioral Therapy for Rumination Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rumination Disorder
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 7
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model 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.
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Pica, Avoidant/Restrictive Food Intake Disorder, Rumination Disorder Interview (PARDI)
timeFrame: Change from baseline to 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
References: