自闭症成人虚拟创伤支持计划的试点参与计划评估
2026年6月5日 更新者:University of Wyoming
创伤后应激障碍 (PTSD) 干预自闭症成人对生物行为健康的疗效
这项单组临床试验的目的是了解远程医疗提供的书面暴露疗法 (WET) 对具有创伤性应激症状的自闭症成人的初步疗效和可行性。 调查人员旨在回答的主要问题是:
- 接受 WET 治疗后,创伤后应激障碍 (PTSD) 的症状和同时发生的心理健康问题是否会减轻?
- 生物行为健康结果,包括客观(Fitbit 活动、睡眠和心率指标)和主观报告的健康变量(例如,睡眠、疼痛、健康相关生活质量),在接受 WET 后是否有所改善?
- 自闭症成人如何体验 WET,以及未来如何与自闭症成人合作修改和增强此计划?
作为研究的一部分,参与者将完成以下内容,该研究完全通过远程医疗完成。
- 参与者将首先完成初步评估,包括对认知和自闭症特征的简要测量,以及关于创伤后应激障碍、心理健康和身体健康的访谈和问卷调查。 如果符合条件,参与者将继续执行以下步骤:
- 然后,符合条件的参与者将开始佩戴 Fitbit,在研究期间使用。
- 然后,参与者将参加涉及 WET 协议的 5 周虚拟访问,包括每周对 PTSD 和身心健康的简要评估。
- 然后,参与者将在下周完成第六次虚拟访问,评估创伤后应激障碍、心理和身体健康以及治疗反馈。
- 最后,参与者将在 1 个月和 6 个月后完成虚拟访问,包括重新评估 PTSD 和身心健康。
因此,这是一个前后单组设计,所有参与者都将获得 WET 以建立初步的有效性和可行性。 调查人员还将在整个项目中咨询自闭症咨询委员会,并根据与自闭症成年人协商的建议进行调整。 目标是更好地了解 WET 支持遭受创伤的自闭症成年人的初步疗效和可行性。
研究概览
地位
地位
完全的
条件
条件
干预/治疗
干预/治疗
研究类型
研究类型
介入性
注册 (实际的)
注册
28
阶段
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
-
-
Wyoming
-
Laramie、Wyoming、美国、82071
- University of Wyoming
-
-
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
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准:
- 自闭症
- 年满 18 岁或以上
- 经历过创伤并报告创伤性应激的临床显着症状(创伤后症状检查表 (PCL-5) 或精神障碍诊断和统计手册结构化临床访谈 (SCID-5) 的临床得分升高,和/或其他自我报告/访谈参与者需要支持/计划的显着创伤性应激症状的证据
- 舒适的英语口语和写作
- Wechsler 缩写智力量表第二版 (WASI-2) 的全面智商 (FSIQ) 分数 >= 65(考虑到书面暴露疗法的书面性质)
- 访问具有互联网访问权限的设备以进行远程医疗访问
排除标准:
- 参与者不是自闭症患者
- 参与者无法理解英语
- 参与者无法访问互联网连接设备进行远程医疗访问
- 参与者在 Wechsler 简略智力量表 - 第二版 (WASI-2) 中获得满量表智商 (FSIQ) 分数 < 65
- 如果任何参与者存在重大安全问题(例如,对自己或他人造成伤害的迫在眉睫的风险),首席研究员可能会确定是否不符合成年人的最佳利益,因为本研究不提供与以下方面相关的护理/服务主动风险。
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)
手臂数量
1
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
实验性的:书面接触疗法
行为疗法:通过远程医疗进行的书面接触疗法
|
通过远程医疗进行书面接触疗法 (WET)
|
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Posttraumatic Symptom Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 is a self-report questionnaire of posttraumatic stress disorder symptoms.
Total scores range from 0-80; higher scores indicate higher levels of posttraumatic stress disorder symptoms.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The PHQ is a self-report measure of depressive symptoms.
Total scores range from 0-27; higher scores reflect greater levels of depressive symptoms.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Anxiety Symptoms on the Anxiety Scale for Autism-Adults (ASA-A)
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Anxiety Scale for Autism-Adults (ASA-A) is a self-report measure for anxiety symptoms among autistic adults.
Total scores range from 0 to 60; higher scores reflect higher anxiety symptoms.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Loneliness Symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The University of California Los Angeles (UCLA) 3-Item Loneliness Scale is a self-report measure for symptoms of loneliness.
Scores range from 3 to 9; higher scores reflect higher levels of loneliness.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Psychological Adjustment Concerns on the Brief Adjustment Scale (BASE-6)
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Brief Adjustment Scale (BASE-6) is a brief self-report symptom monitoring measure for general psychological adjustment.
Scores from from 6 to 42; higher scores reflect greater psychological adjustment concerns.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Experiential Avoidance Symptoms on the Brief Experiential Avoidance Questionnaire
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Brief Experiential Avoidance Questionnaire is a self-report measure of experiential avoidance.
Scores range from 15 to 90; higher scores reflect greater levels of experiential avoidance.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Emotion Regulation Difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Difficulties in Emotion Regulation Scale (DERS-16) is a self-report measure of emotion regulation difficulties.
Scores range from 16 to 80; higher scores reflect greater emotion regulation difficulties.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Stigma Towards Help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Ultra Brief Self-Stigma of Seeking Help (SSOSH-3) Scale is a self-report measure of stigma towards seeking psychological support.
Scores range from 3 to 15; higher scores reflect greater stigma.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Camouflaging Autistic Traits Questionnaire (CATQ) is a self-report measure of masking autistic traits.
Scores range from 25 to 175; greater scores reflect a higher level of camouflaging.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Sleep Difficulties on the Pittsburgh Sleep Quality Index (PSQI)
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep difficulties.
Scores range from 0 to 21; higher scores reflect greater sleep difficulties.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Pain Intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale is a self-report measure of pain intensity.
Total scores range from 3 to 15; higher scores reflect more intense pain.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Pain Interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale is a self-report measure of pain interference.
Total scores range from 8 to 40; higher scores reflect a greater level of pain interference.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Physical Activity as Assessed on Fitbit.
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
Participants Fitbit measurements of number of steps (average past week daily steps) will be assessed via their Fitbit device.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Sleep Duration as Assessed on Fitbit.
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
Participants Fitbit measurements of sleep duration in hours (past weekly nightly average in hours) will be assessed via their Fitbit device.
A higher sleep duration indicates greater numbers slept.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Resting Heart Rate as Assessed on Fitbit.
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
Participants Fitbit measurements of resting heart rate (past week daily average) will be assessed via their Fitbit device.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Autism Spectrum Quality of Life Scale is a self-report measure of quality of life relating to autism.
Total scores range from 9 to 45, and higher scores reflect greater quality of life.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Overall Quality of Life on the World Health Organization Quality of Life Scale
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The World Health Organization Quality of Life Scale (WHO QOL) is a 26-item self-report questionnaire of quality of life.
Summed total scores range from 26 to 130, and higher scores reflect greater quality of life.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
|
Change in Positive Autistic Identity on the Autism Spectrum Identity Scale (ASIS)
大体时间:Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
The Autism Spectrum Identity Scale (ASIS) is a 22-item self-report of autistic identity.
Total scores range from 22 to 110, and higher scores reflect a more positive Autistic identity.
|
Change across baseline to follow-up (e.g., Baseline, End of Intervention [approximately 1 week after intervention completion], 1 month after intervention completion, and 6 months after intervention completion)
|
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 (实际的)
学习开始
2023年10月26日
初级完成 (实际的)
初级完成
2025年2月12日
研究完成 (实际的)
研究完成
2025年2月12日
研究注册日期
首次提交
首次提交
2023年4月25日
首先提交符合 QC 标准的
首先提交符合 QC 标准的
2023年5月7日
首次发布 (实际的)
首次发布
2023年5月17日
研究记录更新
最后更新发布 (实际的)
最后更新发布
2026年7月2日
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
2026年6月5日
最后验证
最后验证
2026年5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.