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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
50
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Robyn P. Thom, MD
- 電話番号：781-860-1711
- メール：luriecenterresearch@mgb.org
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年5月1日
研究の完了 (推定)
2029年5月1日
試験登録日
最初に提出
2026年9月4日
QC基準を満たした最初の提出物
2026年9月4日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026P001463
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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