Clinical trial NCT06687057: A Heart Rate Variability (HRV) Biofeedback Training in Functional Gastrointestinal Disorders (FGID)
Official title: A Heart Rate Variability (HRV) Biofeedback Training to Reduce Symptomatology Associated With Functional Gastrointestinal Disorders (FGID) in College Students.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Functional Gastrointestinal Disorders (FGIDs)
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: University of Padova
name: Catholic University of the Sacred Heart
First posted: 2024-11-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional Gastrointestinal Disorders (FGIDs) are conditions characterized by chronic gastrointestinal symptoms without evidence of pathology. These disorders are believed to result from alterations in gut-brain communication. The most common subtypes are Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), often accompanied by chronic pain, anxiety, and depression. The role of stress in the manifestation of FGIDs is notable, with stress-related distress affecting the nerve pathways that connect gut and brain. Recent interest has focused on the use of Heart Rate Biofeedback (HRV). High levels of stress are associated with reduced HRV, which is common in patients with FGID. HRV biofeedback has been shown to be effective in improving parasympathetic tone and reducing sympathetic tone. The present study aims to evaluate the effectiveness of this approach in reducing stress and symptoms associated with FGIDs in college students.

The project involves online screening to recruit participants, who will then be randomized to receive either the true HRV biofeedback treatment or a placebo condition. Pre- and post-treatment assessments include psychological questionnaires, physiological recordings, and a three-month follow-up. The treatment is expected to improve HRV, thereby reducing anxiety and gastrointestinal symptoms.


Eligibility criteria: Inclusion Criteria:

* presence of clinically significant anxiety symptoms (DASS-21 \> 4)
* presence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS \> 75);
* obtaining informed consent to participate in the study;
* Absence of organic gastrointestinal diseases: thus, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis);
* absence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).

Exclusion Criteria:

* absence of clinically significant anxiety symptoms (DASS-21\< 4);
* absence of symptoms related to Functional Gastrointestinal Disorders (in English, known as Functional Gastrointestinal Disorders (FGIDs)) (IBS-SSS \< 75);
* lack of obtaining Informed Consent to participate in the study;
* presence of organic gastrointestinal diseases: therefore, they will be excluded if with a current or previous diagnosis of intestinal disease (e.g., ulcerative colitis).
* presence of clinical conditions including neurological disorders (previous head trauma, degenerative neurological disorders, stroke, etc.) and cardiovascular disorders (hypertension, cardiac arrhythmias, etc.).

Primary outcomes:
measure: Anxiety
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Stress
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Emotion Regulation
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Irritable Bowel Severity
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Heart Rate Variability
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Secondary outcomes:
measure: Interception
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Emotional State
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Respiratory Rate
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
measure: Depression
timeFrame: Day 0 (T0); Week 4 (T1); Month 3 (T2)
Other outcomes:
Locations:
Study officials:
References:
citation: Lehrer PM, Vaschillo E, Vaschillo B, Lu SE, Eckberg DL, Edelberg R, Shih WJ, Lin Y, Kuusela TA, Tahvanainen KU, Hamer RM. Heart rate variability biofeedback increases baroreflex gain and peak expiratory flow. Psychosom Med. 2003 Sep-Oct;65(5):796-805. doi: 10.1097/01.psy.0000089200.81962.19.
citation: Mather M, Thayer J. How heart rate variability affects emotion regulation brain networks. Curr Opin Behav Sci. 2018 Feb;19:98-104. doi: 10.1016/j.cobeha.2017.12.017.
citation: Goessl VC, Curtiss JE, Hofmann SG. The effect of heart rate variability biofeedback training on stress and anxiety: a meta-analysis. Psychol Med. 2017 Nov;47(15):2578-2586. doi: 10.1017/S0033291717001003. Epub 2017 May 8.