Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
9 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
50
Фаза
- Фаза 2
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Robyn P. Thom, MD
- Номер телефона: 781-860-1711
- Электронная почта: luriecenterresearch@mgb.org
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean 8-Week Change in Aberrant Behavior Checklist (ABC-2) Irritability Subscale Score
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
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Спонсор
Соавторы
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 октября 2026 г.
Первичное завершение (Оцененный)
1 мая 2029 г.
Завершение исследования (Оцененный)
1 мая 2029 г.
Даты регистрации исследования
Первый отправленный
4 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 сентября 2026 г.
Первый опубликованный (Действительный)
10 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
11 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026P001463
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Да
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .