Behavioral Therapy in Patients With Rumination

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Behavioral Therapy in Patients With Rumination

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232097
• Other study ID #: HUS/23/2022
• Secondary ID: HUS/2118/2021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Helsinki University Central Hospital
• Contact: Jari Punkkinen, Dr
• Phone: +358 40 586 1044
• Email: jari.punkkinen[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

Behavioral:
• 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 psychophysical physiotherapist

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Helsinki University Hospital, Childrens' Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (11)

Apajasalo M, Sintonen H, Holmberg C, Sinkkonen J, Aalberg V, Pihko H, Siimes MA, Kaitila I, Makela A, Rantakari K, Anttila R, Rautonen J. Quality of life in early adolescence: a sixteen-dimensional health-related measure (16D). Qual Life Res. 1996 Apr;5(2):205-11. doi: 10.1007/BF00434742. — View Citation

Barba E, Accarino A, Soldevilla A, Malagelada JR, Azpiroz F. Randomized, Placebo-Controlled Trial of Biofeedback for the Treatment of Rumination. Am J Gastroenterol. 2016 Jul;111(7):1007-13. doi: 10.1038/ajg.2016.197. Epub 2016 May 17. — View Citation

Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13. — View Citation

Federici S, Bracalenti M, Meloni F, Luciano JV. World Health Organization disability assessment schedule 2.0: An international systematic review. Disabil Rehabil. 2017 Nov;39(23):2347-2380. doi: 10.1080/09638288.2016.1223177. Epub 2016 Nov 7. — View Citation

Halland M, Pandolfino J, Barba E. Diagnosis and Treatment of Rumination Syndrome. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1549-1555. doi: 10.1016/j.cgh.2018.05.049. Epub 2018 Jun 12. — View Citation

Halland M, Parthasarathy G, Bharucha AE, Katzka DA. Diaphragmatic breathing for rumination syndrome: efficacy and mechanisms of action. Neurogastroenterol Motil. 2016 Mar;28(3):384-91. doi: 10.1111/nmo.12737. Epub 2015 Dec 10. — View Citation

Kessing BF, Bredenoord AJ, Smout AJ. Objective manometric criteria for the rumination syndrome. Am J Gastroenterol. 2014 Jan;109(1):52-9. doi: 10.1038/ajg.2013.428. Epub 2013 Dec 24. — View Citation

Leyfer OT, Ruberg JL, Woodruff-Borden J. Examination of the utility of the Beck Anxiety Inventory and its factors as a screener for anxiety disorders. J Anxiety Disord. 2006;20(4):444-58. doi: 10.1016/j.janxdis.2005.05.004. Epub 2005 Jul 6. — View Citation

Muurinen T, Walamies M. [Rumination in a young woman]. Duodecim. 2015;131(1):76-9. Finnish. — View Citation

Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print. — View Citation

Sintonen H. The 15D instrument of health-related quality of life: properties and applications. Ann Med. 2001 Jul;33(5):328-36. doi: 10.3109/07853890109002086. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of self-perceived rumination frequency	Two point change of rumination frequency measured by the Rome IV questionnaire for adult functional gastrointestinal disorders, question 32. Scale 0-8, 0 = never, 8 = multiple times per day.	Baseline and 6 months
Secondary	Change of abdominal pressure peaks measured by means of esophageal high-resolution manometry	No pancake-meal related abdominal pressure peaks of an amplitude of 30 mm Hg or higher indicating rumination.	6 months
Secondary	Change in health-related quality of life	The 15D-questionnaire will be used for adults and the 16D-questionnaire for patients from 15 to 17 years old. 15D 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 (no problems) to 0 (being dead). The single index (15D score) on a 0-1 scale, representing the overall HRQoL, is calculated from the health state descriptive system by using a set of population-based preference or utility weights. 16D has been developed for adolescents aged 12-18 years. It includes 16 dimensions: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, school and hobbies, mental function, discomfort and symptoms, depression, distress, vitality, appearance, and friends, scored from 0 (min) to 1 (max). The single index (16D score) on a 0 1 scale, representing the overall HRQoL.	Baseline and 6 months
Secondary	Change in functional capacity	Statistically significant change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) questionnaire in patients 18 years or older. WHODAS 2.0 covers 6 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 Participation- joining in community activities The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.	Baseline and 6 months
Secondary	Change in the depression score	Statistically significant change in the Beck Depression Inventory (BDI) questionnaire in patients 18 years or older. BDI is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Each question had a set of at least four possible responses, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows: 0-9: indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression, and 30-63: indicates severe depression.	Baseline and 6 months
Secondary	Change in the anxiety score	Statistically significant change in the Beck Anxiety Inventory (BAI) questionnaire in patients 18 years or older. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are: 0-7: Minimal, 8-15: Mild, 16-25: Moderate, and 26-63: Severe.	Baseline and 6 months