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Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

NCT ID: NCT01576302

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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Rumination

Keywords

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Rumination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diaphragmatic breathing

Training in diaphragmatic breathing as response incompatible with rumination.

Group Type EXPERIMENTAL

Diaphragmatic breathing

Intervention Type BEHAVIORAL

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).

Muscle relaxation

Intervention Type BEHAVIORAL

Progressive passive 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

Group Type ACTIVE_COMPARATOR

Muscle relaxation

Intervention Type BEHAVIORAL

Progressive passive muscle relaxation

Interventions

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Diaphragmatic breathing

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).

Intervention Type BEHAVIORAL

Muscle relaxation

Progressive passive muscle relaxation

Intervention Type BEHAVIORAL

Other Intervention Names

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Relaxation training Progressive Muscle Relaxation

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Richard J. Seime

PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Seime, PhD, LP

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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11-008528

Identifier Type: -

Identifier Source: org_study_id