Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

Study Overview
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Brief Summary
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Rumination is an upper gastrointestinal (GI) disorder characterized by the frequent regurgitation of recently ingested food. Very little is understood about the nature and treatment of this disorder. The act of regurgitation in rumination involves the opening of the upper esophageal sphincter and the muscular contraction of the abdomins rectus. Behavioral treatment of these symptoms is the clinical intervention of choice; however, only uncontrolled case documentation exists to support its effectiveness. However, an effective behavioral mechanism may be relaxation of the muscles. From a behavioral standpoint, muscular relaxation is incompatible with the necessary muscular contraction for rumination. To date, single case documentation and few designed single case studies have examined the clinical effectiveness of behavioral interventions for GI rumination. In the current study, the investigators seek to examine the effectiveness of two behavioral relaxation interventions for GI rumination through a treatment as usual paradigm (proposed N = 20). Our primary goals are to examine the clinical effectiveness of these interventions in symptom reduction at 1- and 3-month follow-up.

Official Title
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Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination

Conditions
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Rumination

Intervention / Treatment
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* Behavioral: Diaphragmatic breathing
* Behavioral: Muscle relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. Diagnosis of rumination by RomeIII criteria Exclusion Criteria: Active alcohol or substance abuse Presence of a depressive disorder as measured by PHQ-9 score of 10 or above Presence of clinical significant anxiety disorder as measured by GAD-7 score of 10 or above. Severe levels of health focused anxiety as measured by SHAI score of 26 or above. Any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures. Any active psychosis or suicidality.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diaphragmatic breathing<br>Training in diaphragmatic breathing as response incompatible with rumination. | Behavioral: Diaphragmatic breathing<br>* Patients in this arm will be provided training in diaphragmatic breathing, taught its application in habit-reversal paradigm (to use after eating food and if urge to ruminate).<br>Behavioral: Muscle relaxation<br>* Progressive passive muscle relaxation<br>* Other names: Progressive Muscle Relaxation;|
| Active Comparator: Muscle relaxation<br>Patients in this arm of study will be taught muscle relaxation as intervention for rumination, instructed in habit-reversal paradigm to use after eating food or if urge to ruminate | Behavioral: Muscle relaxation<br>* Progressive passive muscle relaxation<br>* Other names: Progressive Muscle Relaxation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rumination Frequency assessed using Rome III Criteria | Study participants will be treated with diaphragmatic breathing in one arm and muscle relaxation in the other arm. Outcome measure is: Rome III Study Questions Q8: In the last week, how often did food come back up into your mouth? Q10: When food came back up into your mouth, did it usually stay in your mouth for a while before you swallowed it or spit it out? | 1 month after intervention | 
| Rumination frequency assessed using Rome III Criteria | Study participants will be treated with diaphragmatic breathing in one arm and muscle relaxation in the other arm. Outcome measure is: Rome III Study Questions Q8: In the last week, how often did food come back up into your mouth? Q10: When food came back up into your mouth, did it usually stay in your mouth for a while before you swallowed it or spit it out? | 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heath Care Utilization | How many healthcare visits would you estimate were related to rumination since you started the intervention? | 1 month after intervention | 
| Short Health Anxiety Inventory (SHAI) | Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure | 1 month post intervention | 
| Sheehan Disability Scale (SDS) | This is a measure of the impact of symptoms on Work, Family, and Social life. Uses a 10 point scale --with categories of mild,moderate severe | 1 month after intervention | 
| Treatment adherence | Following question will be posed: Did you engage in the intervention as you were instructed at your training session? The responses will be categorized for themes. | 1 month after intervention | 
| Heath Care Utilization | How many healthcare visits would you estimate were related to rumination since you started the intervention? | 3 month after intervention | 
| Short Health Anxiety Inventory (SHAI) | Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure | 3 months post intervention | 
| Sheehan Disability Scale (SDS) | This is a measure of the impact of symptoms on Work, Family, and Social life. Uses a 10 point scale --with categories of mild,moderate severe | 3 months after intervention | 
| Treatment adherence | Following question will be posed: Did you engage in the intervention as you were instructed at your training session? The responses will be categorized for themes. | 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rumination