Recruiting
Phase 2

HRVB

Sponsor:

Massachusetts General Hospital

Code:

NCT07812233

Conditions

Autism Spectrum Disorder

Anxiety

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Lief Smart Patch

Study Details

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

Study ID

NCT07812233

Start date

Oct 26, 2026

Status verified date

Oct, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Heart rate variability biofeedback

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.

Interventions

Lief Smart Patch

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.

Primary outcome measure

  • Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score [ Time Frame: Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported ]

Central Contacts and Locations

Central contacts

Robyn P. Thom, MD

781-860-1711luriecenterresearch@mgb.org

Locations

Lurie Center

Recruiting

Lexington, Massachusetts, United States, 02421

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.