治疗性骑马干预对 ASD 青年精神病人群的生理机制
2026年7月24日 更新者:University of Colorado, Denver
与自闭症谱系障碍青少年精神病人群的即时和长期治疗性骑马干预效果相关的生理机制
这项随机对照试验 (RCT) 旨在评估治疗性骑马 (THR) 之前观察到的对 ASD 青少年显着积极影响的机制,特别是那些患有并发精神疾病的青少年,并完善有关持久性、剂量和亚群的信息干预的效果。
研究概览
详细说明
这项随机对照试验 (RCT) 将检验以下假设:唾液皮质醇、心血管和皮肤电活动的生理反应模式解释了我们之前观察到的显着结果(即减少烦躁和多动,改善社交和沟通)和其他结果(情绪调节照顾者生活质量和危机心理保健使用情况),在 6-16 岁的青少年中。
与无马谷仓活动 (BA) 对照(目标 1)相比,自闭症谱系障碍和同时发生的精神病诊断被随机分配到为期 10 周的手动 THR 干预组。
我们将在干预期六个月后评估 THR 组与 BA 对照组相比目标 1 结果的持久性(目标 2)。
最后,我们将通过比较 THR 和 BA 组与 (a) 10 周等候名单对照组的效应量差异来探索 THR 和 BA 干预的剂量和亚群效应; (b) 混合干预组(五周 BA,随后五周 THR); (c) THR 研究人群的子样本在精神病院住院后被随机分配(目标 3)。
研究类型
介入性
注册 (实际的)
236
阶段
- 不适用
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。
学习地点
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Colorado
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Aurora、Colorado、美国、80218
- University of Colorado Anschutz Medical Campus
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Maine
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Portland、Maine、美国、04102
- Maine Health
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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
6年 至 17年 (孩子)
接受健康志愿者
是的
描述
纳入标准:
- 有记录的 ASD 诊断和同时发生的精神疾病
- ABC 易激惹分量表得分≥8
- Leiter-III 非语言智商 ≥ 40
- 符合 CASI-5 上的症状标准评分(DSM-V(情绪、焦虑或 ADHD 诊断)所需的最少症状数)
- 满足 SCQ (≥ 11) 和 ADOS-2 上的 ASD 临界值
- 每个家庭只有一名 ASD 儿童保持独立观察
- 始终如一的照顾者(即父母或法定监护人)以完成研究结果测量
排除标准:
- 妨碍参与的医疗或行为问题
- 州政府
- 在骑行中心屏幕中被判断为具有显着的骑行体验
- 定期吸烟或定期使用口服、吸入或局部类固醇,已知影响皮质醇水平的因素
- 根据骑行中心的安全政策,体重 200 磅或以上的参与者将被排除在外
- 考虑到 THR 效果维持六个月的试点证据,参与者将不得开始基线评估,直到他们最后一次参与安装的 EAAT 至少六个月后。
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:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:候补名单
那些被分配到候补名单的人在 10 周的等待期内不会接受任何与马匹相关的干预。
在这段等待期和完成后评估之后,处于这种情况的参与者将开始一个混合组(参见混合臂)
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实验性的:骑马治疗
该小组是一个为期 10 周、一小时的小组(2-4 名参与者),由 THR 教练带领。
该小组将包括一个 45 分钟的固定活动,以学习该研究的 THR 手册中概述的马术技能。
小组时间将在下午 1:00-5:00 之间收集唾液皮质醇。
每周,参与者将遵循一致的惯例,佩戴皮肤电活动和心率监测设备,课前坐在小组艺术桌前,之后,研究人员将指导参与者将 10 厘米长的泡沫拭子棒放在舌下一边观看一分钟计时器一分钟。
随后,参赛者将戴上骑行头盔,进入骑行场地。
每周 THR 干预结束后,参与者将再次与他们的小组一起坐在艺术桌前 5 分钟,然后再进行一次唾液样本。
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马疗法
其他名称:
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有源比较器:谷仓活动
该小组是一个为期 10 周、一小时的小组(2-4 名参与者),由 THR 教练领导,并由心理健康或职业治疗提供者共同领导。
参与者将有一名指定的志愿者,并且不会与马术中心的马匹进行身体接触,只是从远处观看马匹。
将有一匹真人大小的毛绒玩具马,用于根据文学学士学习手册进行与每周主题相关的实践学习。
小组时间将在下午 1:00-5:00 之间收集唾液皮质醇。
每周,参与者将遵循一致的惯例,佩戴皮肤电活动和心率监测设备,课前坐在小组艺术桌前,之后,研究人员将指导参与者将 10 厘米长的泡沫拭子棒放在舌下一边观看一分钟计时器一分钟。
BA 干预结束后每周,参与者将再次与他们的小组一起坐在艺术桌前 5 分钟,然后再进行一次唾液样本。
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马术组
其他名称:
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实验性的:杂交种
完成等待名单上的评估和后期评估的参与者将在下午 1:00-5:00 之间开始混合组。
该小组由为期 5 周、每次 1 小时的 BA 小组(2-4 名参与者)组成,由 THR 讲师领导,并由心理健康顾问或 OT 共同领导。
参与者将有一名指定的志愿者,并且在马术中心与马匹没有身体接触,只是远远地观察马匹。
每份文学学士学习手册都会有一匹真人大小的毛绒马,用于每周实践学习主题。
团体。
然后,参与者将在 THR 教练的带领下完成为期 5 周的治疗性骑马小组(2-4 名参与者)。
该团体将包括 45 分钟的骑马活动,以学习马术技能,然后根据 THR 手册进行 15 分钟的非骑马梳理和追踪活动。
参与者将拥有指定的马匹和志愿者。
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地面和骑行活动
其他名称:
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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 |
|---|---|---|
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Aberrant Behavior Checklist-Community (ABC-C) - Baseline
大体时间:Baseline
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The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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Baseline
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Aberrant Behavior Checklist-Community (ABC-C) - End of Treatment
大体时间:End of Treatment
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The ABC-C is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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End of Treatment
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Aberrant Behavior Checklist-Community (ABC-C) - 6 Months Post Treatrment
大体时间:6 months post intervention
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The ABC is a 58-item caregiver-completed symptom checklist of 5 behavior subscales (i.e.
Irritability, Lethargy, Stereotypy, Hyperactivity, Inappropriate Speech) capturing problem behaviors of children and adults with developmental disabilities in community settings on each subscale.
THIS MEASURE DOES NOT GENERATE A TOTAL SCORE.
Subscale symptom presence and severity scores range from 0 "not a problem" to higher scores indicating more severe problems.
The Irritability subscale scores can range between 0-45; The Lethargy subscale scores can range between 0-48; The Stereotypy subscale scores can range between 0-21; The Hyperactivity subscale scores can range between 0-48; The Inappropriate Speech subscale scores can range between 0-12.
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6 months post intervention
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Social Responsiveness Scale™, Second Edition - End of Treatment
大体时间:End of Treatment
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of g 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
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End of Treatment
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Social Responsiveness Scale™, Second Edition - 6 Months Post Treatment
大体时间:6 months post intervention
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The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
THIS STUDY USED RAW SCORES FOR ANALYSES.
FOR ALL SCALES, HIGHER RAW SCORES INDICATE WORSE OUTCOME.
Combined Social Responsiveness Scale total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
Social Communication raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 47. Social Motivation raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 26.
Restricted/Repetitive Behavior raw scores range from a MINIMUM score of 0 to a MAXIMUM score of 28.
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6 months post intervention
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Emotion Dysregulation Inventory (EDI) - Baseline
大体时间:Baseline
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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Baseline
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Emotion Dysregulation Inventory (EDI) - End of Treatment
大体时间:End of Treatment
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
Each scale (Reactivity and Dysphoria) raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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End of Treatment
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Emotion Dysregulation Inventory (EDI) - 6 Months Post Treatment
大体时间:6 months post intervention
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The EDI is a 30-item caregiver report form that is comprised of a 24-item EDI Reactivity scale and 6-item Dysphoria scales that are scored separately.
The Reactivity subscale captures intense, rapidly escalating, sustained, and poorly regulated negative emotional reactions.
The Dysphoria scale captures minimal positive affect and motivation along with the presence of nervousness and sadness.
For each scale (Reactivity and Dysphoria), raw scores were converted into t-scores using the Clinical (ASD) sample t-score with a mean= 50 and standard deviation = 10 (citation here).
The theoretical bound of both subscale t-scores is 20-80 and higher scores indicate more symptom severity.
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6 months post intervention
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Systematic Analysis of Language Transcripts (SALT) - Baseline
大体时间:Baseline
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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Baseline
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Systematic Analysis of Language Transcripts (SALT) - End of Treatment
大体时间:End of Treatment
|
Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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End of Treatment
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Systematic Analysis of Language Transcripts (SALT) - 6 Months Post Treatment
大体时间:6 months post treatment
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Systematic Analysis of Language Transcripts (SALT) provides standardized guidelines to elicit, transcribe, and analyze language samples from individuals, including those with ASD.
The SALT also provides language analysis programs to compute a vocabulary diversity quotient from transcripts entered into the database.
A five-minute expressive language sample was elicited by each participant and recorded by the project's Speech Therapist, blind to participants' randomized group assignment.
Participant's total number of words and total number of different words is dependent on their verbal output during the 5-minute speech sample and use of more words during the language sample is optimal.
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6 months post treatment
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - Baseline
大体时间:Baseline
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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Baseline
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - End of Treatment
大体时间:End of Treatment
|
The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.
Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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End of Treatment
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World Health Organization's Quality of Life Instrument (WHOQOL-BREF) - 6 Months Post Treatment
大体时间:6 months post intervention
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The WHOQOL-BREF is a validated self-report instrument consisting of 26 Likert-scale items rated on a five-point scale.
Four primary domain scores of well-being were calculated from 24 items: physical health (7 items), psychological health (6 items), social relationships (3 items), and environment (8 items).
Domain scores were transformed to a 0-100 scale by dividing the raw domain score by the potential maximum score and multiplying by 100, with higher scores indicating better quality of life; these transformed scores are reported here.Therefore, for each of the scales (i.e., physical health, psychological health, social relationships, and environment) the minimum score is a value of 0 and the maximum score is a value of 100 with higher scores indicating better quality of life.
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6 months post intervention
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Social Responsiveness Scale™, Second Edition - Baseline
大体时间:Baseline
|
The SOCIAL RESPONSIVENESS SCALE™, Second Edition is a 65-item caregiver-report measure that evaluates social impairments in ASD.
The Social Responsiveness Scale™-Second Edition generates raw scores and t-scores for both the combined total score as well as for each of the 5 subscales (social awareness, social cognition, social communication, social motivation, and restricted/repetitive behaviors).
NOTE: THIS STUDY USED THE RAW SCORES FOR ANALYSES.
The combined Social Responsiveness Scale™-Second Edition total raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 134.
HIGHER SCORES ON THIS SCALE INDICATE WORSE OUTCOMES.
The Social Awareness raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 19.
HIGHER SCORES ON THIS SUBSCALE INDICATE WORSE OUTCOMES.
The Social Cognition raw scores RANGE from a MINIMUM score of 0 to a MAXIMUM score of 28.
HIGHER SCORES ON THIS SUBSCALE.
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Baseline
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Salivary Cortisol - Baseline Baseline
大体时间:Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before (i.e., "Pre-session") and 20 minutes after (i.e., "Post-Session) each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed separately.
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Baseline sample was taken from each participant's viable cortisol sample from week 1 or if not a viable sample, then from the closest following week (i.e., either week 2 or 3).
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Salivary Cortisol - Mid-Point
大体时间:Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
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Mid point sample was taken from each participant's viable cortisol sample from week 5 or if not a viable sample, then from the closest following week (i.e., either week 6 or 7)
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Salivary Cortisol - End of Treatment
大体时间:Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
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Each participant donated approximately 0.5-1 mL of saliva at the riding center within 5 minutes before and 20 minutes after each THR or BA group session weeks 1-10.
Salivary cortisol collected pre- and -post intervention activities were analyzed.
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Endpoint sample was taken from each participant's viable cortisol sample from week 10 or if not a viable sample, then from the closest preceding week (i.e., either week 9 or 8).
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Heart Rate Variability - Baseline
大体时间:Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Baseline ECG was taken from each participant's viable ECG data recording from week 1 or if not viable ECG data, then from the closest following week (i.e., either week 3 or 4).
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Heart Rate Variability - Mid-point
大体时间:Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
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The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Mid-point ECG was taken from each participant's viable ECG data recording from week 5 or if not viable ECG data, then from the closest following week (i.e., either week 6 or 7).
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Heart Rate Variability - End of Treatment
大体时间:Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
|
The Shimmer3 cardiac (ECG) monitor was used in this study.
This cardiovascular monitor was specifically developed to record electrocardiographic signals while participants are active or in motion.
The form factor is compact (about 2" by 1"), lightweight (13g), and designed to wear continuously and unobtrusively.
It samples ECG and HRV up to 2,048 Hz, which is sufficient for research.125
It has a built-in accelerometer for quantifying periods of physical activity, necessary to identify signal artifacts in post-processing.
Participants' Shimmer3 ECG assessments were measured continuously during the intervention lesson.
Unit of measure is ms log-10 transformed.
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Endpoint ECG was taken from each participant's at week 10 or if not viable ECG data, then from the closest preceding week (i.e., either week 9 or 8).
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Electrodermal Activity -- Baseline
大体时间:Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured during the intervention lesson.
Unit of measure is microsiemens.
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Baseline EDA was taken from each participant's viable EDA data recording from week 1 or if not viable EDA data, then from the closest following week (i.e., either week 3 or 4).
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Electrodermal Activity - Mid-point
大体时间:Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
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Midpoint EDA was taken from each participant's viable EDA data recording from week 5 or if not viable EDA data, then from the closest following week (i.e., either week 6 or 7).
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Electrodermal Activity - End of Treatment
大体时间:Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
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The Shimmer3 EDA monitor was used to record EDA from participants' ventral area of the wrist using alternating current imperceptibly applied to the skin through two hypoallergenic, durable, and replaceable Ag electrodes.
As dry non-adhesive electrodes tend to move on the skin surface during physical activity and destroy signal quality, disposable adhesive electrodes with an appropriate salinity (e.g., 0.5%; EL507) were used.
EDA sampling frequency in the Shimmer3 is 4 Hz with a 0.01- 100uS range.
Peripheral skin temperature was recorded by the Shimmer3 EDA monitor at 4 Hz in the -40 to 115-Celsius range using optical infrared thermopile.
The Shimmer3 EDA recorded motion-based activity up to ±8g at 32 Hz using 3-axis accelerometry.
Participants' Shimmer3 EDA assessments were measured continuously during the intervention lesson.
Unit of measure is microsiemens.
|
Endpoint EDA was taken from each participant's at week 10 or if not viable EDA data, then from the closest preceding week (i.e., either week 9 or 8).
|
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。
合作者
调查人员
- 首席研究员:Robin L Gabriels, Psy.D.、University of Colorado Anzchutz Medical Campus
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 (实际的)
2020年12月22日
初级完成 (实际的)
2025年2月22日
研究完成 (实际的)
2025年2月22日
研究注册日期
首次提交
2020年10月15日
首先提交符合 QC 标准的
2020年10月22日
首次发布 (实际的)
2020年10月28日
研究记录更新
最后更新发布 (实际的)
2026年8月18日
上次提交的符合 QC 标准的更新
2026年7月24日
最后验证
2026年7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.