Heart-rate variability (HRV) biofeedback for gut–brain symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

College students with functional gastrointestinal disorder symptoms and elevated anxiety will be identified through online screening and enrolled at the Milan site. Eligible participants (IBS-SSS > 75 and DASS-21 anxiety > 4, without organic GI, cardiovascular, or major neurological disease) will be assigned to receive HRV biofeedback training or a placebo training. The interventions aim to change autonomic balance, and outcomes will include changes in HRV metrics, stress/anxiety scores, and validated GI symptom scales. Data will be collected before and after the training to compare symptom and physiological changes between groups.

Why it matters

Who can join: the full rules

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.).

Where it's running

• Eleonora Volpato
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Eleonora Volpato, PsyD, PhD
• Email: eleonora.volpato@unicatt.it
• Phone: 3293782692

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.