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NCT07812233
Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
Conditions: Autism Spectrum Disorder, Anxiety
Sex: All
Ages: 12 Years – 17 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Massachusetts General Hospital
Summary
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.
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
Source: ClinicalTrials.gov (NCT07812233). StuddyBuddy aggregates publicly available trial information.