Heart Rate Variability Biofeedback for Anxiety in Autistic Youth

NCT07812233 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026P001463
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Autism Spectrum Disorder; Anxiety

Keywords

heart rate variability biofeedback; Lief; autism spectrum disorder; anxiety

Outcome Measures

Primary Outcomes (1)

• Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score

  The PARS, a clinician-administered measure of child anxiety symptom severity based on both patient and parent-report will be the primary outcome measure. It has demonstrated inter-rater and test-retest reliability, and has previously been used by our group as the primary outcome measure in a RCT of mirtazapine for anxiety in youth with ASD, demonstrating sensitivity to change. The 5-item PARS score will be the primary outcome measure for this trial. Scaled score ranges from 0-25 with higher scores indicating more severe anxiety symptoms.

  Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Secondary Outcomes (5)

• Proportion of Participants who Responded to Treatment at 8 Weeks According to the Improvement Item of the Clinical Global Impression-Improvement (CGI-I) (Response Defined as CGI-I = 1 or 2)

  Week 4, Week 8. Week 8 score reported.

• Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S)

  Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.

• Mean 8-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score

  Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.

• mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients

  Week 8

• Feasibility

  Week 8

Other Outcomes (7)

• Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score

  Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

• Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Lethargy/Social Withdrawal Subscale Score

  Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

• Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Stereotypic Behavior Subscale Score

  Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported

Study Arms (1)

Heart rate variability biofeedback

EXPERIMENTAL

Participants will be asked to practice HRVB for 5 minutes twice per day at times of their choosing throughout the 8-week trial. In addition to scheduled practice sessions, participants will be asked to respond to just-in-time adaptive intervention (JITAI) prompts to do brief, \~2-minute bursts of HRVB when the device senses autonomic hyperarousal. Participants will be instructed to complete ≥5 minutes per day of JITAI-delivered HRVB, self-initiated HRVB in response to self-perceived anxiety or stress, or any combination of these two practice modes.

Device: Lief Smart Patch

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.

Heart rate variability biofeedback

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Eagles Autism Foundation: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Robyn P. Thom, MD

CONTACT

781-860-1711; luriecenterresearch@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share