自閉症の成人向け仮想トラウマ支援プログラムのパイロット参加型プログラムの評価
2026年6月5日 更新者：University of Wyoming
成人自閉症に対する心的外傷後ストレス障害（PTSD）介入の生物行動的健康に対する有効性
この単一グループ臨床試験の目的は、心的外傷性ストレス症状のある成人自閉症者に対する遠隔医療による筆記曝露療法 (WET) の初期の有効性と実現可能性について学ぶことです。 調査員が答えようとしている主な質問は次のとおりです。
- WETを受けた後、心的外傷後ストレス障害（PTSD）の症状や併発する精神的健康上の懸念は軽減されますか?
- 客観的（活動量、睡眠、心拍数の Fitbit 指標）および主観的に報告される健康変数（睡眠、痛み、健康関連の生活の質など）を含む生物行動学的健康成果は、WET を受けた後に改善しますか?
- 自閉症の成人はどのようにWETを経験するのでしょうか?また、自閉症の成人と協力して、将来このプログラムをどのように修正し、強化できるでしょうか?
参加者は研究の一環として以下の作業を完了します。この研究は完全に遠隔医療で完了します。
- 参加者はまず、認知と自閉症の特性の簡単な測定、PTSD、精神的健康、身体的健康に関するインタビューとアンケートを含む初期評価を完了します。 資格がある場合、参加者は次の手順に進みます。
- 資格のある参加者は、研究期間中使用する Fitbit の装着を開始します。
- その後、参加者は、PTSD と精神的および身体的健康の週次の簡単な評価を含む、WET プロトコルを含む週 5 回の仮想訪問に参加します。
- その後、参加者は翌週に 6 回目の仮想訪問を完了し、PTSD、精神的および身体的健康、治療のフィードバックが評価されます。
- 最後に、参加者は 1 か月後と 6 か月後に仮想訪問を完了し、PTSD と精神的および身体的健康の再評価を行います。
したがって、これは事前事後単一グループ設計であり、すべての参加者が最初の有効性と実現可能性を確立するために WET を受けます。 研究者らはまた、プロジェクト全体を通じて自閉症諮問委員会と相談し、自閉症の成人との協議の中で推奨された修正を加えます。 目標は、トラウマを経験した自閉症の成人を支援するための WET の初期の有効性と実現可能性をより深く理解することです。
調査の概要
研究の種類
介入
入学 (実際)
28
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Wyoming
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Laramie、Wyoming、アメリカ、82071
- University of Wyoming
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 自閉症
- 年齢 18 歳以上
- 外傷を経験しており、外傷性ストレスの臨床的に重大な症状を報告している（外傷後症状チェックリスト（PCL-5）または精神障害の診断と統計マニュアルのための構造化臨床面接（SCID-5）のいずれかで臨床的に高いスコア、および/またはその他の自己申告） /参加者がサポートを望んでいる重大なトラウマ性ストレス症状の証拠を面接する/プログラム
- 快適な英語でのスピーキングとライティング
- ウェクスラー簡易知能指数第 2 版 (WASI-2) におけるフルスケール知能指数 (FSIQ) スコア >= 65 (筆記曝露療法の筆記的性質を考慮)
- 遠隔医療訪問のためのインターネット アクセスを備えたデバイスへのアクセス
除外基準:
- 参加者は自閉症ではありません
- 参加者は英語を理解できません
- 参加者は遠隔医療訪問のためにインターネットに接続されたデバイスにアクセスできません
- 参加者は、ウェクスラー簡易知能指数第 2 版 (WASI-2) でフルスケール知能指数 (FSIQ) スコアが 65 未満である
- 参加者に重大な安全上の懸念がある場合（例、自傷または他人に危害を及ぼす差し迫ったリスク）、この研究が以下に関連するケア/サービスを提供していないことを考慮すると、研究代表者は、登録することが成人の最善の利益にならないかどうかを判断する場合があります。アクティブリスク。
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：書面暴露療法
行動療法: 遠隔医療による書面曝露療法
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遠隔医療による書面曝露療法 (WET)
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Posttraumatic Stress Disorder (PTSD) Symptoms on the Posttraumatic Symptom Checklist for DSM-5 (PCL-5) Scale
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Depressive Symptoms on the Patient Health Questionnaire (PHQ) Scale
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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)
|
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Change in Resting Heart Rate as Assessed on Fitbit.
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Autistic Quality of Life on the Autism Spectrum Quality of Life Scale.
時間枠：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
時間枠：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)
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年10月26日
一次修了 (実際)
2025年2月12日
研究の完了 (実際)
2025年2月12日
試験登録日
最初に提出
2023年4月25日
QC基準を満たした最初の提出物
2023年5月7日
最初の投稿 (実際)
2023年5月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月2日
QC基準を満たした最後の更新が送信されました
2026年6月5日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20230331CM03524
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。