RECRUITING Phase 2 ClinicalTrials.gov

Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

Sponsor: Massachusetts General Hospital • ClinicalTrials.gov ID: NCT07812233

Registry updated: 2026-10-16

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Description

Heart rate variability biofeedback (HRVB) is a breathing-based intervention that reduces anxiety in a range of populations. Second-generation wearable HRVB devices not only deliver scheduled biofeedback practice sessions but also allow patients to practice HRVB in-the-moment when it is needed most. This study is testing the acceptability, feasibility, and preliminary efficacy of second-generation, ambulatory HRVB for the treatment of anxiety in autistic youth.

Interventions

Lief Smart Patch (Device)
The Lief Smart Patch is a commercially available, noninvasive wearable heart rate variability biofeedback (HRVB) device. The patch includes an embedded electrocardiogram (ECG) sensor and accelerometer that interfaces with a companion smartphone application to deliver paced breathing exercises and just-in-time adaptive intervention (JITAI) prompts. It is an externally worn patch that temporarily adheres to the skin surface and can be removed by the participant.

Eligibility criteria

Inclusion Criteria: 1. Age 12-17 years at the time of enrollment. 2. ASD diagnosis from a qualified health professional based on medical records and confirmed based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria by the study clinician. 3. IQ ≥50 based on the Kaufman Brief Intelligence Test (KBIT-2). 4. Clinically significant anxiety, based on the Pediatric Anxiety Rating Scale (PARS) 5-item score of ≥10. 5. Stable medications for ≥30 days. 6. English speaking. 7. Willing to wear the Lief Smart Patch for 8 weeks. 8. English speaking guardian who is willing and able to complete caregiver assessments. Exclusion Criteria: 1. Clinically significant cardiac arrhythmia based on parent report. 2. Current primary diagnosis of bipolar disorder, psychosis, substance use disorder, posttraumatic stress disorder, eating disorder, or major depressive disorder that requires a different treatment based in the opinion of the PI. 3. Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI

Conditions

Autism Spectrum Disorder Anxiety

Locations

Lurie Center — Lexington, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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