Clinical trial NCT01576302: Comparison of Diaphragmatic Breathing and Muscle Relaxation for Rumination
Official title: Diaphragmatic Breathing and Progressive Muscle Relaxation: Behavioral Interventions for Gastrointestinal Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rumination
Keywords: Rumination
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-04-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Rumination Frequency assessed using Rome III Criteria
timeFrame: 1 month after intervention
measure: Rumination frequency assessed using Rome III Criteria
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Heath Care Utilization
timeFrame: 1 month after intervention
measure: Short Health Anxiety Inventory (SHAI)
timeFrame: 1 month post intervention
measure: Sheehan Disability Scale (SDS)
timeFrame: 1 month after intervention
measure: Treatment adherence
timeFrame: 1 month after intervention
measure: Heath Care Utilization
timeFrame: 3 month after intervention
measure: Short Health Anxiety Inventory (SHAI)
timeFrame: 3 months post intervention
measure: Sheehan Disability Scale (SDS)
timeFrame: 3 months after intervention
measure: Treatment adherence
timeFrame: 3 months after intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Richard Seime, PhD, LP
role: PRINCIPAL_INVESTIGATOR
References: