Wearable breathing biofeedback patch for anxiety in autistic teenagers
Tests a wearable breathing biofeedback device for anxiety in autistic teenagers.
Plain-language title generated from the registry record
Registry title: Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
Key facts
- Where
- Lexington, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT07812233, who can take part
Where in United States
- Lurie CenterLexington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT07812233
- Record updated
- 16 October 2026
- Original 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.Read full original descriptionShow less
Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
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.
Inclusion: Age 12-17 years at the time of enrollment; 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; IQ ≥50 based on the Kaufman Brief Intelligence Test (KBIT-2); Clinically significant anxiety, based on the Pediatric Anxiety Rating Scale (PARS) 5-item score of ≥10; Stable medications for ≥30 days; English speaking; Willing to wear the Lief Smart Patch for 8 weeks; English speaking guardian who is willing and able to complete caregiver assessments.
Exclusion: Clinically significant cardiac arrhythmia based on parent report; 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; Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI.