Heart Rate Variability Biofeedback for Anxiety in Autistic Youth
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Lief Smart Patch (Device)
结局指标
主要结局
Mean 8-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
时间窗: 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.
次要结局
- 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)(Week 4, Week 8. Week 8 score reported.)
- Mean 8-Week Change in Clinical Global Impression Severity Subscale (CGI-S)(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(Baseline, Week 4, Week 8; Change from Baseline to Week 8 reported.)
- mHealth App Usability Questionnaire (MAUQ) Standalone Apps for Patients(Week 8)
- Feasibility(Week 8)
研究者
Robyn P. Thom, M.D.
Associate Professor of Psychiatry
Massachusetts General Hospital