Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

Phase 3

Completed

• Conditions: Rumination
• Interventions: Behavioral: Diaphragmatic breathing; Behavioral: Muscle relaxation

• Registration Number: NCT01576302
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-09
• Study First Submitted QC: 2012-04-10
• Study First Posted: 2012-04-12
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. At least 18 years of age.
2. Diagnosis of rumination by RomeIII criteria

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Exclusion Criteria

1. Active alcohol or substance abuse
2. Presence of a depressive disorder as measured by PHQ-9 score of 10 or above
3. Presence of clinical significant anxiety disorder as measured by GAD-7 score of 10 or above.
4. Severe levels of health focused anxiety as measured by SHAI score of 26 or above.
5. Any medical, neurological, or psychiatric condition that would impair the ability to consent and carry out all study procedures.
6. Any active psychosis or suicidality.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diaphragmatic breathing	Diaphragmatic breathing	Training in diaphragmatic breathing as response incompatible with rumination.
Muscle relaxation	Muscle relaxation	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
Diaphragmatic breathing	Muscle relaxation	Training in diaphragmatic breathing as response incompatible with rumination.

Primary Outcome Measures

Name	Time	Method
Rumination Frequency assessed using Rome III Criteria	1 month after intervention	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?
Rumination frequency assessed using Rome III Criteria	3 months after intervention	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?

Secondary Outcome Measures

Name	Time	Method
Heath Care Utilization	3 month after intervention	How many healthcare visits would you estimate were related to rumination since you started the intervention?
Short Health Anxiety Inventory (SHAI)	3 months post intervention	Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure
Treatment adherence	3 months after intervention	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.
Sheehan Disability Scale (SDS)	3 months after intervention	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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States