Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

NCT01576302 | Completed Phase 3

• 1 other identifier: 11-008528
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Rumination

Keywords

Rumination

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Heath Care Utilization

  1 month after intervention

• Short Health Anxiety Inventory (SHAI)

  1 month post intervention

• Sheehan Disability Scale (SDS)

  1 month after intervention

• Treatment adherence

  1 month after intervention

• Heath Care Utilization

  3 month after intervention

Study Arms (2)

Diaphragmatic breathing

EXPERIMENTAL

Training in diaphragmatic breathing as response incompatible with rumination.

Behavioral: Diaphragmatic breathing; Behavioral: Muscle relaxation

Muscle relaxation

ACTIVE COMPARATOR

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

Interventions

Diaphragmatic breathing 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).

Diaphragmatic breathing

Muscle relaxation BEHAVIORAL

Progressive passive muscle relaxation

Also known as: Relaxation training, Progressive Muscle Relaxation

Diaphragmatic breathing; Muscle relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Rumination Syndrome

Interventions

Muscle Relaxation; Relaxation Therapy; Autogenic Training

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis

Study Officials

• Richard Seime, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

US (1)