- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576302
Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Diaphragmatic breathing
Training in diaphragmatic breathing as response incompatible with rumination.
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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).
Progressive passive muscle relaxation
Other Names:
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ACTIVE_COMPARATOR: 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
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Progressive passive muscle relaxation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rumination Frequency assessed using Rome III Criteria
Time Frame: 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? |
1 month after intervention
|
Rumination frequency assessed using Rome III Criteria
Time Frame: 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? |
3 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heath Care Utilization
Time Frame: 1 month after intervention
|
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)
Time Frame: 1 month post intervention
|
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)
Time Frame: 1 month 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
|
1 month after intervention
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Treatment adherence
Time Frame: 1 month 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.
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1 month after intervention
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Heath Care Utilization
Time Frame: 3 month after intervention
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How many healthcare visits would you estimate were related to rumination since you started the intervention?
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3 month after intervention
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Short Health Anxiety Inventory (SHAI)
Time Frame: 3 months post intervention
|
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)
Time Frame: 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
|
3 months after intervention
|
Treatment adherence
Time Frame: 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.
|
3 months after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Seime, PhD, LP, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-008528
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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