Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
2026年9月9日 更新者：Robyn P. Thom, M.D.、Massachusetts General Hospital
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.
研究概览
详细说明
Fifty youth with autism and clinically significant anxiety will be recruited to participate in a single-arm, 8-week open-label, fully remote trial of HRVB.
Participants will utilize the Lief Smart Patch which delivers HRVB training and practice through an embedded ECG monitor, accelerometer, and companion smartphone app.
Specific aims of the research include: 1) Determine the acceptability and feasibility of second generation HRVB in autistic youth; and 2) Evaluate the preliminary efficacy of HRVB for the treatment of anxiety in autistic youth.
研究类型
介入性
注册 (估计的)
50
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Robyn P. Thom, MD
- 电话号码：781-860-1711
- 邮箱：luriecenterresearch@mgb.org
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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)
大体时间：Week 4, Week 8. Week 8 score reported.
|
The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment.
The CGI-I scale ranges from 1 to 7 (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scales indicating improvement (1=very much improved; 2=much improved).
In this study, the CGI-I will be focused on the target symptom of anxiety.
|
Week 4, Week 8. Week 8 score reported.
|
|
Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S)
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.
|
The CGI-S is rated on a scale from 1 to 7, where 1 = normal, not at all ill; 3 = mildly ill; 5 = markedly ill; 7 = among the most extremely ill patients.
The CGI-S will be rated based on the severity of anxiety symptoms.
|
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
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.
|
The PRAS-ASD is a novel parent-rated 25-item scale with demonstrated reliability and validity.
Scores range from 0-75, with higher scores indicating more severe parent-rated anxiety.
|
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.
|
|
mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients
大体时间：Week 8
|
Mean Likert rating on the mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients.
The MAUQ includes 18 questions, each rated on a Likert scale of 1-7.
Total scores range from 18-126, with higher scores indicating increased usability.
|
Week 8
|
|
Feasibility
大体时间：Week 8
|
Proportion of enrolled youth meeting the scheduled daily practice criterion (≥50% study days with ≥5 minutes combined JITAI-delivered and self-initiated HRVB practice).
|
Week 8
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis.
It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment.
The Irritability Subscale is derived from 15 items, with a score range from 0-45, where higher scores indicate more severe irritability.
|
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
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis.
It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment.
The Lethargy/Withdrawal Subscale is derived from 16 items, with a score range from 0-48 where higher scores indicate more severe Lethargy/Withdrawal symptoms.
|
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
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis.
It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment.
The Stereotypic Behavior Subscale is derived from 7 items, with a score range of 0-21 where higher scores indicate more severe stereotypic behaviors.
|
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
|
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Hyperactivity Subscale Score
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis.
It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment.
The Hyperactivity Subscale is derived from 16 items with a score range of 0-48, where severe scores indicate more severe hyperactivity symptoms.
|
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
|
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Inappropriate Speech Subscale Score
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
The ABC-2 is a 58-item questionnaire with 5 subscales derived by factor analysis.
It has been extensively used in psychopharmacological studies of ASD and assesses many symptoms that are either central to autism or frequently a target of treatment.
The Inappropriate Speech Subscale is derived from 4 items with a score range of 0-12, where higher scores indicate more severe Inappropriate Speech symptoms.
|
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
|
Mean 8-Week Change in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
The ADHD-RS is an 18-question, parent-rated assessment reflecting DSM symptoms of ADHD.
The score range is 0-54, with higher scores indicating more severe ADHD symptoms.
|
Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported
|
|
Mean 8-Week Change in Children's Sleep Habits Questionnaire (CSHQ) Total Score
大体时间：Baseline, Week 4, Week 8; Change from Baseline to Week 8 is reported
|
The CSHQ is a 52-question parent survey used to assess sleep difficulties.
33 items are used to generate the total score, which ranges from 33-99, with a cutoff of >41 suggesting clinically significant sleep problems.
Higher scores are indicative of more severe sleep problems.
|
Baseline, Week 4, Week 8; Change from Baseline to Week 8 is reported
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2029年5月1日
研究完成 (估计的)
2029年5月1日
研究注册日期
首次提交
2026年9月4日
首先提交符合 QC 标准的
2026年9月4日
首次发布 (实际的)
2026年9月10日
研究记录更新
最后更新发布 (实际的)
2026年9月11日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.