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.

Overview

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.

Interventions

• Behavioral HRV Biofeedback Training
  The intervention involves 5 training sessions lasting 45 minutes (specifically, 5-minute baseline and 5 HRV biofeedback trials lasting 5 minutes each) according to the protocol published by Lehrer et al. (2013). Physiological signals (ECG and respiratory rate) will be recorded during all sessions. During the training, participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing. They will be asked to synchronize the two signals so t
• Other Placebo Training
  The Placebo procedure requires participants to attend 5 sessions lasting 45 minutes during which they perform a task. Physiological signals (ECG and respiration rate) will be recorded during all sessions. Participants will see on the screen a graph representing heart rate superimposed on a graph representing abdominal breathing but these will not directly reflect the subject's cardiorespiratory activity. Participants in the control group will be asked to synchronize the two signals so that the c

Primary outcome measures

• Anxiety [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Stress [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Emotion Regulation [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Irritable Bowel Severity [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Heart Rate Variability [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]

Secondary outcome measures (4)

• Interception [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Emotional State [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Respiratory Rate [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]
• Depression [Time frame: Day 0 (T0); Week 4 (T1); Month 3 (T2)]

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Eleonora Volpato — Milan

Publications

• 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. PMID 14508023
• 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. PMID 29333483
• 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. PMID 28478782

Identifiers

NCT: NCT06687057 · UCSC_123_24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗