Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
Recruiting
Phase 2
Interventional Study
Autism Spectrum Disorder
Anxiety
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for autistic youth aged 12 to 17 who experience anxiety. Participants will use a wearable device that helps them manage their anxiety over 8 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 12 and 17 years old.
- I have been diagnosed with Autism Spectrum Disorder.
- I have an IQ of 50 or higher.
- I have clinically significant anxiety.
- I have been stable on my medications for at least 30 days.
- I speak English.
- I am willing to wear the Lief Smart Patch for 8 weeks.
- I have an English-speaking guardian who can complete assessments.
You may not be able to join if
- I have a serious heart condition.
- I have a current diagnosis of bipolar disorder.
- I have a current diagnosis of psychosis.
- I have a current substance use disorder.
- I have PTSD or an eating disorder that needs different treatment.
- I have a major depressive disorder that requires different treatment.
- I have an unstable medical or psychiatric condition.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About 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,…
Trial Locations
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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 th…
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