NCT05862467已完成不适用
Efficacy of a Posttraumatic Stress Disorder (PTSD) Intervention for Autistic Adults on Biobehavioral Health
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in posttraumatic stress disorder (PTSD) symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
研究概览
简要总结
The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are:
- Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET?
- Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET?
- How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults?
Participants will complete the following as part of the study, which is completed entirely over telehealth.
- Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps:
- Eligible participants will then start wearing a Fitbit, to be used for the duration of the study.
- Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health.
- Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed.
- Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health.
Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.
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
盲法说明
No masking -- as single group design, all participants receive the program.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Has experienced trauma and reports clinically significant symptoms of traumatic stress (clinically elevated score on either Posttraumatic Symptom Checklist (PCL-5) or Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID-5), and/or other self-report/interview evidence of significant traumatic stress symptoms for which participant wants support/program
- •Comfortable speaking and writing in English
- •Full Scale Intelligence Quotient (FSIQ) score >= 65 (given written nature of Written Exposure Therapy) on the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
- •Access to device with internet access for telehealth visits
排除标准
- •Participant is not Autistic
- •Participant is unable to understand English
- •Participant is currently receiving trauma-focused therapeutic services
- •Participant does not have access to internet connected device for telehealth visits
- •Participant receives Full Scale Intelligence Quotient (FSIQ) score < 65 on the Wechsler Abbreviated Scale of Intelligence-Second Edition (WASI-2)
- •If there are significant safety concerns for any participant (e.g., imminent risk of harm to self or other) the Principal Investigator may determine whether it is not in the adult's best interest to be enrolled given that this study does not provide care/services relating to active risk.
研究组 & 干预措施
Written Exposure Therapy
Experimental
Behavioral therapy: Written Exposure Therapy via telehealth
干预措施: Written Exposure Therapy (WET) via telehealth (Behavioral)
结局指标
主要结局
Change in posttraumatic stress disorder (PTSD) symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
时间窗: Change across baseline to follow-up (an average of 6 months)
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 in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
时间窗: 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.
次要结局
- Change in depressive symptoms on the Patient Health Questionnaire (PHQ) Scale(Change across baseline to follow-up (an average of 6 months))
- Change in anxiety symptoms on the Anxiety Scale for Autism-Adults (ASA-A)(Change across baseline to follow-up (an average of 6 months))
- Change in camouflaging on the Camouflaging Autistic Traits Questionnaire (CATQ)(Change across baseline to follow-up (an average of 6 months))
- Change in pain intensity on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form Scale.(Change across baseline to follow-up (an average of 6 months))
- Change in emotion regulation difficulties on the Difficulties in Emotion Regulation Scale (DERS-16)(Change across baseline to follow-up (an average of 6 months))
- Change in pain interference on the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Interference Short Form Scale.(Change across baseline to follow-up (an average of 6 months))
- Change in sleep quality as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
- Change in psychological adjustment concerns on the Brief Adjustment Scale (BASE-6)(Change across baseline to follow-up (an average of 6 months))
- Change in experiential avoidance symptoms on the Brief Experiential Avoidance Questionnaire(Change across baseline to follow-up (an average of 6 months))
- Change in PTSD symptoms on the clinician-administered Structured Clinical Interview for DSM-5(Change across baseline to follow-up (an average of 6 months))
- Change in sleep duration as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
- Change in resting heart rate as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
- Change in loneliness symptoms on the University of California Los Angeles (UCLA) 3-Item Loneliness Scale(Change across baseline to follow-up (an average of 6 months))
- Change in physical activity as assessed on Fitbit.(Change across baseline to follow-up (an average of 6 months))
- Change in stigma towards help-seeking on the Ultra-Brief Self-Stigma of Seeking Help (SSOSH-3) Scale(Change across baseline to follow-up (an average of 6 months))
- Change in sleep difficulties on the Pittsburgh Sleep Quality Index (PSQI)(Change across baseline to follow-up (an average of 6 months))
- Change in health-related quality of life on the Centers for Disease Control Health-Related Quality of Life Scale (CDC HRQOL)(Change across baseline to follow-up (an average of 6 months))
- Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale(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)(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(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)(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(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)(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(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)(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)(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.(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.(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.(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.(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.(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))
研究者
研究点 (2)
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