Heart Rate Variability Biofeedback for Autism and Anxiety
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for autistic youth aged 12-17 who have significant anxiety, an IQ of at least 50, stable medications for at least a month, and can speak English. Participants must be willing to wear a smart patch device for 8 weeks and have an English-speaking guardian able to help with assessments.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lief Smart Patch
Trial Overview
The study tests the Lief Smart Patch, a wearable device that uses heart rate variability biofeedback (a breathing technique) to help reduce anxiety in autistic youth. The trial looks at how practical and helpful this approach is over an 8-week period.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Eagles Autism Foundation
Collaborator
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