慢性筋骨格痛を持つ若者のためのデジタル曝露治療のアジャイル開発
2026年6月23日 更新者：Lauren Harrison、Stanford University
このプロジェクトは、逐次複製およびランダム化された単一症例実験計画 (SCED) を利用して、慢性筋骨格痛を持つ若者に対するデジタルで提供される段階的曝露治療の実現可能性と予備的有効性を体系的に開発し、評価することを提案しています。 SCED は、個人レベルで治療効果を厳密に評価する機会を提供します。
iGET Living の開発は、慢性的な痛みを持つ青少年 (N = 15) とその親 (N = 15) の少数のサンプルに対するアルファ テスト (目的 1) を伴う、一連の短い反復に基づいて行われます。 目標 1 では、参加者は 3 つの 2 時間のフォーカス グループ (3 週間にわたって週に 1 つ) に参加するため、目標 1 では参加者 1 人あたり合計 6 時間の参加となります。
目的 2 には、世間知らずのエンドユーザーのサンプル (N = 20 人の若者、N = 20 人の親) が含まれます。 参加者は、7～25 日間のベースライン期間 (SCED 方法論をサポートするために行われます) に登録され、その後、6 週間続くオンライン介入プログラムに登録されます。 患者は治療から退院してから 3 か月後 (登録の 22 週目) に連絡され、この時点で自己報告の転帰測定を完了します。
調査の概要
研究の種類
介入
入学 (実際)
108
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
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California
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Menlo Park、California、アメリカ、94025
- Pediatric Pain Management Clinic
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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
10年～17年 (子、大人)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 10～17歳の青少年
- 慢性筋骨格痛と診断されている（3か月以上）
- 中程度から高度の疼痛干渉がある (PROMIS 疼痛干渉 ≥ 61)
- 英語の読み書きができる
- インターネットに接続できるパソコン、スマートフォン、タブレットが使えること
除外基準:
- 重度の認知障害（脳損傷など）
- 治療を妨げる重大な医学的または精神医学的問題
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：非ランダム化
- 介入モデル：並列代入
- 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 |
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実験的：段階的暴露介入
目的 2 では、慢性疼痛を抱える青少年が、新規のデジタル配信による段階的曝露治療の受け入れ可能性、実現可能性、予備的有効性を調べる単群実施可能性試験に登録されます。
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段階的曝露は、理論に基づいて個別に調整され、証拠に基づいた慢性疼痛患者向けの行動介入であり、患者をこれまで恐れ、避けていた活動に曝露することで、疼痛関連障害をターゲットにします。
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介入なし：User centered development
For Aim 1, participants engaged with the prototypes of the intervention and provided feedback.
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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 |
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Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1)
時間枠：One day
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Participant-rated acceptability measured on 5-point Likert scale.
Range 0-4 (higher scores indicate more acceptable).
Questionnaire will be administered to youth with chronic pain and their parents.
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One day
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Participant Satisfaction With the Intervention (Aim 2)
時間枠：10 weeks (assessed at discharge)
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Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997).
The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention.
Scores range from 0-92.
A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content.
Caregivers were not assessed for this Outcome Measure.
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10 weeks (assessed at discharge)
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Percentage of Participants Dropped Out of Intervention (Aim 2)
時間枠：10 weeks (Completed at discharge)
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As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention.
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10 weeks (Completed at discharge)
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Expectations for Treatment (Aim 2)
時間枠：Assessed seven days after starting the intervention (7 days post-baseline)
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To assess expectations for treatment effectiveness, participants completed the Credibility/Effectiveness Questionnaire (CEQ; Borkovec & Nau, 1972) after engaging with iGET Living for one week.
The CEQ consists of six items rated on a 0 (not at all) to 10 (very much) Likert scale and assesses expectations related to the effects of the intervention across two subscales: Credibility (e.g., "How confident would you be recommending iGET Living to a friend with the same problems?")
and Expectancy (e.g., "By the end of iGET Living, how much do you think your functioning will improve?").
Credibility is calculated by summing items 1-3 and Expectancy by summing items 4-6.
Possible range of scores for each subscale is 0-30, with higher scores reflecting greater perceived credibility and expectancy.
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Assessed seven days after starting the intervention (7 days post-baseline)
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Functional Disability (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker & Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts.
Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible).
Scores from all the Items are summed to create a total score (range 0-60), with higher scores indicating greater disability.
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Child Fear of Pain (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Fear of Pain Questionnaire, Child Report, Short Form (FOPQ-C-SF, Heathcote et al., 2020) is a 10-item self-report measure that assesses pain-related fear and avoidance of activities.
Items are rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree).
Scores from all the Items are summed to create a total score ranging from 0 - 40.
Higher scores indicate higher levels of pain-related fear and avoidance (worst outcome).
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Parental Fear of Pain (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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The Parent Fear of Pain Questionnaire (PFOPQ, Simons et al., 2015) assesses parent's fear associated with their child's pain experiences.
The PFOPQ contains 23 items assessed on a 5-point Likert scale (0 = "strongly disagree" to 4 "strongly agree").
Items are summed to create a total score (0-92), with higher scores indicated greater parent fear associated with their child's pain.
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Child Pain Catastrophizing (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain.
The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true").
A total score (0-52) is obtained by summing all items.
Higher scores indicate higher levels of catastrophic thinking.
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Parent Pain Catastrophizing (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain.
It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true").
A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking.
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Child Pain Acceptance (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form (CPAQ-A8, Gauntlett-Gilbert et al., 2018) will be used to assess pain acceptance in the child.
The CPAQ-A8 is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items).
Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16.
Higher scores indicate greater Activity Engagement and greater Pain Willingness (positive outcome) .
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Parent Psychological Flexibility (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain.
Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40.
Higher scores indicate greater parent psychological flexibility (positive outcome).
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Parent Responses to Childs Pain (Aim 2)
時間枠：Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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Adult Responses to Children's Symptoms (ARCS, Claar et al., 2010) assesses parents' behavioral responses to children's pain behaviors.
The Protect subscale (13 items) will be utilized in this study.
The Protect scale refers to protective parental behavior, such as giving the child special attention and limiting the child's normal activities and responsibilities.
All items are rated on a 5-point Likert scale (0 = "never" to 4 "always"), and are averaged to create a total score ranging from 0-4.
Higher scores indicating greater use of protective behavioral responses to their child's pain (worst outcome).
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Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)
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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
協力者
捜査官
- 主任研究者：Lauren E Harrison, PhD、Stanford University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
- Crombez G, Bijttebier P, Eccleston C, Mascagni T, Mertens G, Goubert L, Verstraeten K. The child version of the pain catastrophizing scale (PCS-C): a preliminary validation. Pain. 2003 Aug;104(3):639-646. doi: 10.1016/S0304-3959(03)00121-0.
- Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
- Groenewald CB, Essner BS, Wright D, Fesinmeyer MD, Palermo TM. The economic costs of chronic pain among a cohort of treatment-seeking adolescents in the United States. J Pain. 2014 Sep;15(9):925-33. doi: 10.1016/j.jpain.2014.06.002. Epub 2014 Jun 19.
- Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain. 2008 Mar;9(3):226-36. doi: 10.1016/j.jpain.2007.10.015. Epub 2007 Dec 21.
- King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.
- Goubert L, Eccleston C, Vervoort T, Jordan A, Crombez G. Parental catastrophizing about their child's pain. The parent version of the Pain Catastrophizing Scale (PCS-P): a preliminary validation. Pain. 2006 Aug;123(3):254-263. doi: 10.1016/j.pain.2006.02.035. Epub 2006 Apr 27.
- Vlaeyen JWS, Crombez G, Linton SJ. The fear-avoidance model of pain. Pain. 2016 Aug;157(8):1588-1589. doi: 10.1097/j.pain.0000000000000574. No abstract available.
- Wilson K, Bell C, Wilson L, Witteman H. Agile research to complement agile development: a proposal for an mHealth research lifecycle. NPJ Digit Med. 2018 Sep 13;1:46. doi: 10.1038/s41746-018-0053-1. eCollection 2018.
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- Peng P, Stinson JN, Choiniere M, Dion D, Intrater H, Lefort S, Lynch M, Ong M, Rashiq S, Tkachuk G, Veillette Y; STOPPAIN Investigators Group. Dedicated multidisciplinary pain management centres for children in Canada: the current status. Can J Anaesth. 2007 Dec;54(12):985-91. doi: 10.1007/BF03016632.
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- Simons LE, Sieberg CB, Carpino E, Logan D, Berde C. The Fear of Pain Questionnaire (FOPQ): assessment of pain-related fear among children and adolescents with chronic pain. J Pain. 2011 Jun;12(6):677-86. doi: 10.1016/j.jpain.2010.12.008. Epub 2011 Feb 26.
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- Borkovec TD, & Nau, S. D. . Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychology 1972;3:257-60
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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)
2022年5月2日
一次修了 (実際)
2025年5月13日
研究の完了 (実際)
2025年10月1日
試験登録日
最初に提出
2021年10月4日
QC基準を満たした最初の提出物
2021年10月4日
最初の投稿 (実際)
2021年10月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22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23日
最終確認日
2026年6月1日
詳しくは
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。