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Behavioral Therapy in Patients With Rumination

Behavioral Therapy in Patients With Rumination

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05232097
Enrollment
11
Registered
2022-02-09
Start date
2022-01-01
Completion date
2023-12-31
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders

Brief summary

The study aim is to diagnose patients with the rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles. Before referral to the study, gastroscopy, esophageal hgh-resolution manometry and 24-hour esophageal pH and impedance monitoring are required to rule out other esophageal conditions. Twenty Finnish speaking, 15-70 years old patients will be enrolled in this open study. All patients will visit the gastroenterologist at onset of the study and at 6 months. All patients will be referred to the speech therapist for five one-hour sessions consisting of diaphragmatic belching exercises and to the physiotherapist for two one-hour sessions consisting of exercises to relax tensed thoracic and abdominal muscles. All patients will also visit once the psychologist and dietician. Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases at onset and at the 6-month control. Health-related quality of life, depression, anxiety, functional capacity will be evaluated by specific questionnaires at onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control.

Detailed description

Background: Rumination is a subconscious but a volitional, behavioral disorder. Contraction of the abdominal muscles results in an increase of abdominal pressure and a subsequent regurgitation of recently ingested food, followed by rechewing, reswallowing or spitting (1). The diagnosis is based on the Rome IV criteria for functional gastrointestinal disorders and esophageal high-resolution manometry (1, 2). Behavioral therapy consisting of diaphragmatic breathing exercises has proven efficient in these patients (3, 4). Psychophysical physiotherapy was effective in a published patient case (5). Aim: The study aim is to diagnose patients with rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy. The primary aim is a reduction of two points ore more in the rumination frequency measured by the Rome IV questionnaire for adult functional gastrointestinal diseases (6). Secondary aims are improved esophageal high-resolution manometry, health-related quality of life, and functional capacity and reduced anxiety and depression scores. Patients: 20 Finnish speaking, 15-70 years old patients with rumination symptoms fulfilling the Rome IV criteria will be enrolled in this open study. Before referral to Helsinki University Central Hospital, gastroscopy, esophageal high-resolution manometry and esophageal 24-hour pH and impedance monitoring are required. Adolescents of 15 to 17 years old are referred to the childrens' gastroenterologist and adults 18 years or older are referred to the gastroenterologist. The inclusion criteria consist of rumination symtoms fulfilling the Rome IV criteria but esophageal high-resolution manometry may be negative because rumination cannot be always provoked during the study.The exclusion criteria comprise eating disorder, BMI \<14, pregnancy, cognitive or other disorder that disallows behavioral therapy Methods: Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases in all patients. Health-related quality of life will be evaluated by 15D, a 15-dimensional measure of health-related quality of life, depression by Beck Depression Inventory (BDI), anxiety by the Beck Anxiety Inventory (BAI), and functional capacity by WHODAS 2.0, World Health Organization disability assesment schedule 2.0 in the patients 18 years or older (7-10). In the patients 15-17 years old, health-related qualiy of life will be evaluated by 16D, a sixteen-dimensional health-related measure for adolescents (11). All questionnaires will be carried out at the onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control. After the baseline visit to the gastroenterologist, patients will be sent to the speech therapist for five, one-hour sessions consisting of diaphragmatic breathing exercises and to a psychophysical physiotherapist for two one-hours sessions aiming at body-awareness to sense tensed thoracic and abdominal muscles and to relax them through guided exercises. Patients will continue these exercises at home during meals. All patient l visit the psychologist and dietician once to rule out eating disorders and other psychopathological conditions and will be referred to the psychiatrist when necessary. Esophageal high-resolution manometry will be performed at the 6-month control.

Interventions

BEHAVIORALBehavioral therapy

Diaphragmatic breathing exercises

BEHAVIORALPhysiotherapy

Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the psychophysical physiotherapist

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Rome IV criteria for rumination syndrome fulfilled * gastroscopy, esophageal HR-manometry and 24-hour pH-impedance monitoring performed before referral to study

Exclusion criteria

* eating disorder, BMI \<14, pregnancy, cognitive or other disorder that disallows behavioral therapy

Design outcomes

Primary

MeasureTime frameDescription
Rumination Score (Self-perceived Rumination Frequency)6-month controlRumination score measured by question 32 of the Rome 4 diagnostic questionnaire for adult functional gastrointestinal disorders. The question scores the rumination frequency as follows: In the last 3 months, how often did food come back up into your mouth after you swallowed it ?, 0 = never, 1= fewer than 1 day a month, 2 = 1 day a month, 3 = 2-3 days a month, 4 = 1 day a week, 5 = 2-3 days a week, 6 = most days, 7 = every day, 8 = multiple times per day or all the time. Scale 0-8, the highest score indicating highest frequency of rumination.

Secondary

MeasureTime frameDescription
Health-related Quality of Life (15D)6-month controlThe 15D, a 15-dimensional measure of health-related quality of life includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number calculated over all the dimensions, is ranged from the maximum score 1 (no problems on any dimension) to the minimum score 0 (being dead).
Functional Capacity (WHODAS 2.)6-month controlWHODAS 2.0, the WHO Disability Assessment Schedule 2.0 questionnaire, covers six domains of functioning, including: Cognition - understanding & communicating, Mobility- moving & getting around, Self-care- hygiene, dressing, eating & staying alone, Getting along- interacting with other people, Life activities- domestic responsibilities, leisure, work & school, and Participation- joining in community activities. Each domain is ranged from 0 (no disability) to 100 (full disability). The WHODAS 2.0 summary score consisting of all six domains is converted to metric ranging from 0 to 100, with 0 indicating no disability and 100 full disability.
Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher6-month controlNumber of patients with abdominal pressure peaks of an amplitude of 30 mm Hg or higher measured by means of esophageal high-reselution manometry indicating rumination.
Anxiety Score (BAI)6-month controlBeck Anxiety Inventory (BAI) Score, scale 0-63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
Weight6-month controlWeight in kilograms
Depression Score (BDI)6-month controlBeck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.

Countries

Finland

Participant flow

Participants by arm

ArmCount
Behavioral Therapy
Behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles Behavioral therapy: Diaphragmatic breathing exercises Physiotherapy: Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the body-mind orientated physiotherapist
11
Total11

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision1

Baseline characteristics

CharacteristicBehavioral Therapy
Age, Continuous38 years
Anxiety score (BAI)18 Units on a score
Depression score (BDI)12 Score on scale
Functional capacity (WHODAS 2.0)26 units on a scale
Healt-related quality of life (15D)0.793 units on a scale
STANDARD_DEVIATION 0.171
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
10 Participants
Region of Enrollment
Finland
11 participants
Rumination score (self-perceived rumination frequency)6.5 units on a scale
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
1 Participants
Weight71 kilograms

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 11
other
Total, other adverse events
0 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

Primary

Rumination Score (Self-perceived Rumination Frequency)

Rumination score measured by question 32 of the Rome 4 diagnostic questionnaire for adult functional gastrointestinal disorders. The question scores the rumination frequency as follows: In the last 3 months, how often did food come back up into your mouth after you swallowed it ?, 0 = never, 1= fewer than 1 day a month, 2 = 1 day a month, 3 = 2-3 days a month, 4 = 1 day a week, 5 = 2-3 days a week, 6 = most days, 7 = every day, 8 = multiple times per day or all the time. Scale 0-8, the highest score indicating highest frequency of rumination.

Time frame: 6-month control

Population: The 10 patients who finished the study.

ArmMeasureValue (MEDIAN)
Behavioral TherapyRumination Score (Self-perceived Rumination Frequency)4 score on a scale
Comparison: Null hypothesis: the median of differences of the rumination score before and after therapy equals 0.p-value: 0.005Wilcoxon (Mann-Whitney)
Secondary

Anxiety Score (BAI)

Beck Anxiety Inventory (BAI) Score, scale 0-63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).

Time frame: 6-month control

Population: The 8 patients who returned the BAI questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control.

ArmMeasureValue (MEDIAN)
Behavioral TherapyAnxiety Score (BAI)15 score on a scale
Comparison: Null hypothesis: The differences of median of BAI before and after behavioral therapy equals 0.p-value: 1Wilcoxon (Mann-Whitney)
Secondary

Depression Score (BDI)

Beck Depression Inventory (BDI) Score, scale 0-63. Total score of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.

Time frame: 6-month control

Population: The 8 patients who returned the BDI-questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control.

ArmMeasureValue (MEDIAN)
Behavioral TherapyDepression Score (BDI)7 score on a scale
Comparison: Null hypothesis : the differences of median BDI before and after behavioral therapy equals 0.p-value: 0.149Wilcoxon (Mann-Whitney)
Secondary

Functional Capacity (WHODAS 2.)

WHODAS 2.0, the WHO Disability Assessment Schedule 2.0 questionnaire, covers six domains of functioning, including: Cognition - understanding & communicating, Mobility- moving & getting around, Self-care- hygiene, dressing, eating & staying alone, Getting along- interacting with other people, Life activities- domestic responsibilities, leisure, work & school, and Participation- joining in community activities. Each domain is ranged from 0 (no disability) to 100 (full disability). The WHODAS 2.0 summary score consisting of all six domains is converted to metric ranging from 0 to 100, with 0 indicating no disability and 100 full disability.

Time frame: 6-month control

Population: The 8 patients who returned the WHODAS 2.0 questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 patients did not return the questionnaire at the 6-month control.

ArmMeasureValue (MEDIAN)
Behavioral TherapyFunctional Capacity (WHODAS 2.)11 units on a scale
Comparison: Null hypothesis: The median of differences of WHODAS 2.0 before and after therapy equals 0.p-value: 0.865Wilcoxon (Mann-Whitney)
Secondary

Health-related Quality of Life (15D)

The 15D, a 15-dimensional measure of health-related quality of life includes 15 dimensions: breathing, mental function, speech, vision, mobility, usual activities, vitality, hearing, eating, elimination, sleeping, distress, discomfort and symptoms, sexual activity, and depression, each scored from 1 (best possible) to 0 (worst possible). The 15D score, a single index number calculated over all the dimensions, is ranged from the maximum score 1 (no problems on any dimension) to the minimum score 0 (being dead).

Time frame: 6-month control

Population: The 8 patients who returned the 15D-questionnaire both at baseline and at the 6-month control. Out of the 10 patients who finished the study, 2 did not return the questionnaire at the 6-month control.

ArmMeasureValue (MEAN)Dispersion
Behavioral TherapyHealth-related Quality of Life (15D)0.845 units on a scaleStandard Deviation 0.141
Comparison: Null hypothesis: The differences of means of 15D before and after therapy equals 0.p-value: 0.06t-test, 2 sided
Secondary

Number of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher

Number of patients with abdominal pressure peaks of an amplitude of 30 mm Hg or higher measured by means of esophageal high-reselution manometry indicating rumination.

Time frame: 6-month control

Population: The 9 patients who were performed manometry at the 6-month control. Out of the 10 patients who finished the study, one refused.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Behavioral TherapyNumber of Patients With Abdominal Pressure Peaks of an Amplitude of 30 mmHg or Higher6 Participants
Comparison: The null hypothesis is that the same number of patients has intragastric pressure peaks indicating rumination before and after therapy.p-value: 0.11Chi-squared
Secondary

Weight

Weight in kilograms

Time frame: 6-month control

Population: All 10 patients who finished the study.

ArmMeasureValue (MEDIAN)
Behavioral TherapyWeight71 kilogram
Comparison: Null hypothesis: The differences of median weight before and after therapy equals 0.p-value: 0.102Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026