Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Rumination

Treatments: Behavioral: Muscle relaxation; Behavioral: Diaphragmatic breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT01576302

11-008528

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Diaphragmatic breathing

Experimental group

Description:

Training in diaphragmatic breathing as response incompatible with rumination.

Treatment:

Behavioral: Diaphragmatic breathing

Behavioral: Muscle relaxation

Muscle relaxation

Active Comparator group

Description:

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

Treatment:

Behavioral: Muscle relaxation