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Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Richard J. Seime, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01576302
First received: April 9, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Rumination
Behavioral: Diaphragmatic breathing
Behavioral: Muscle relaxation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Rumination Frequency assessed using Rome III Criteria [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]

    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 [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]

    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:
  • Heath Care Utilization [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    How many healthcare visits would you estimate were related to rumination since you started the intervention?

  • Short Health Anxiety Inventory (SHAI) [ Time Frame: 1 month post intervention ] [ Designated as safety issue: No ]
    Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure

  • Sheehan Disability Scale (SDS) [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    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

  • Treatment adherence [ Time Frame: 1 month after intervention ] [ Designated as safety issue: No ]
    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.

  • Heath Care Utilization [ Time Frame: 3 month after intervention ] [ Designated as safety issue: No ]
    How many healthcare visits would you estimate were related to rumination since you started the intervention?

  • Short Health Anxiety Inventory (SHAI) [ Time Frame: 3 months post intervention ] [ Designated as safety issue: No ]
    Measure of degree to which intervention has impacted health concerns/anxiety. The SHAI is a validated measure

  • Sheehan Disability Scale (SDS) [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
    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

  • Treatment adherence [ Time Frame: 3 months after intervention ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diaphragmatic breathing
Training in diaphragmatic breathing as response incompatible with rumination.
Behavioral: 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).
Behavioral: Muscle relaxation
Progressive passive muscle relaxation
Other Names:
  • Relaxation training
  • Progressive Muscle Relaxation
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
Behavioral: Muscle relaxation
Progressive passive muscle relaxation
Other Names:
  • Relaxation training
  • Progressive Muscle Relaxation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576302

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Richard J Seime, Ph.D    507-284-2649    seime.richard@mayo.edu   
Contact: Jennifer M. Craft, Ph.D.    507 284 5849    craft.jennifer@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Richard Seime, PhD, LP Mayo Clinic
  More Information

No publications provided

Responsible Party: Richard J. Seime, PHD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01576302     History of Changes
Other Study ID Numbers: 11-008528
Study First Received: April 9, 2012
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Rumination

ClinicalTrials.gov processed this record on November 20, 2014