- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05079984
만성 근골격계 통증이 있는 청소년을 위한 디지털 노출 치료법의 민첩한 개발
이 프로젝트는 순차적 복제 및 무작위 단일 사례 실험 설계(SCED)를 활용하여 만성 근골격계 통증이 있는 청소년을 위한 디지털 방식으로 제공되는 단계별 노출 치료법의 타당성과 예비 효과를 체계적으로 개발하고 평가할 것을 제안합니다. SCED는 개인 수준에서 치료 효과를 엄격하게 평가할 수 있는 기회를 제공합니다.
iGET Living의 개발은 만성 통증이 있는 청소년(N = 15)과 그 부모(N = 15)의 소규모 표본에 대한 알파 테스트(목표 1)를 통한 일련의 짧은 반복을 기반으로 합니다. 목표 1의 경우 참가자는 3개의 2시간 포커스 그룹에 참여하게 되며(3주 동안 매주 1회) 목표 1의 경우 참가자당 총 6시간이 참여하게 됩니다.
목표 2에는 순진한 최종 사용자의 샘플(N = 청소년 20명, 부모 N = 20명)이 포함됩니다. 참가자는 7~25일(SCED 방법론 지원을 위해 수행됨) 범위의 기본 기간에 등록된 후 6주 동안 지속되는 온라인 중재 프로그램에 등록됩니다. 환자는 치료 종료 후 3개월(등록 22주차)에 연락을 받게 되며 이때 자체 보고 결과 측정을 완료하게 됩니다.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Menlo Park, California, 미국, 94025
- Pediatric Pain Management Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 만 10~17세 청소년
- 만성 근골격계 통증 진단을 받은 자(3개월 이상)
- 중간 정도에서 높은 수준의 통증 간섭이 있음(PROMIS 통증 간섭 ≥ 61)
- 영어 가능
- 인터넷에 연결된 컴퓨터, 스마트폰 또는 태블릿에 액세스할 수 있습니다.
제외 기준:
- 심각한 인지 장애(예: 뇌 손상)
- 치료에 지장을 줄 수 있는 심각한 의학적 또는 정신적 문제
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 단계적 노출 개입
목표 2의 경우, 만성 통증이 있는 청소년은 새로운 디지털 방식으로 제공되는 단계적 노출 치료법의 수용성, 타당성 및 예비 효과를 조사하는 단일군 타당성 시험에 등록됩니다.
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단계적 노출은 환자를 이전에 두려워하고 회피했던 활동에 노출시킴으로써 통증 관련 손상을 목표로 하는 만성 통증이 있는 개인을 위한 이론 중심의 개별 맞춤형 증거 기반 행동 중재입니다.
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간섭 없음: User centered development
For Aim 1, participants engaged with the prototypes of the intervention and provided feedback.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Child Fear of Pain (Aim 2)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Lauren E Harrison, PhD, Stanford University
간행물 및 유용한 링크
일반 간행물
- 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.
- Murray CB, Groenewald CB, de la Vega R, Palermo TM. Long-term impact of adolescent chronic pain on young adult educational, vocational, and social outcomes. Pain. 2020 Feb;161(2):439-445. doi: 10.1097/j.pain.0000000000001732.
- Groenewald CB, Patel KV, Rabbitts JA, Palermo TM. Correlates and motivations of prescription opioid use among adolescents 12 to 17 years of age in the United States. Pain. 2020 Apr;161(4):742-748. doi: 10.1097/j.pain.0000000000001775.
- 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.
- Eccleston C, Blyth FM, Dear BF, Fisher EA, Keefe FJ, Lynch ME, Palermo TM, Reid MC, Williams ACC. Managing patients with chronic pain during the COVID-19 outbreak: considerations for the rapid introduction of remotely supported (eHealth) pain management services. Pain. 2020 May;161(5):889-893. doi: 10.1097/j.pain.0000000000001885. No abstract available.
- Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G. The treatment of fear of movement/(re)injury in chronic low back pain: further evidence on the effectiveness of exposure in vivo. Clin J Pain. 2002 Jul-Aug;18(4):251-61. doi: 10.1097/00002508-200207000-00006.
- Simons LE, Harrison LE, O'Brien SF, Heirich MS, Loecher N, Boothroyd DB, Vlaeyen JWS, Wicksell RK, Schofield D, Hood KK, Orendurff M, Chan S, Lyons S. Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Contemp Clin Trials Commun. 2019 Sep 10;16:100448. doi: 10.1016/j.conctc.2019.100448. eCollection 2019 Dec.
- 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.
- Simons LE, Smith A, Kaczynski K, Basch M. Living in fear of your child's pain: the Parent Fear of Pain Questionnaire. Pain. 2015 Apr;156(4):694-702. doi: 10.1097/j.pain.0000000000000100.
- Claar RL, Guite JW, Kaczynski KJ, Logan DE. Factor structure of the Adult Responses to Children's Symptoms: validation in children and adolescents with diverse chronic pain conditions. Clin J Pain. 2010 Jun;26(5):410-7. doi: 10.1097/AJP.0b013e3181cf5706.
- Timmers I, Simons LE, Hernandez JM, McCracken LM, Wallace DP. Parent psychological flexibility in the context of pediatric pain: Brief assessment and associations with parent behaviour and child functioning. Eur J Pain. 2019 Aug;23(7):1340-1350. doi: 10.1002/ejp.1403. Epub 2019 May 14.
- Gauntlett-Gilbert J, Alamire B, Duggan GB. Pain Acceptance in Adolescents: Development of a Short Form of the CPAQ-A. J Pediatr Psychol. 2019 May 1;44(4):453-462. doi: 10.1093/jpepsy/jsy090.
- Palermo T. Remote management of pediatric pain. Encyclopedia of Pain 2nd Edition New York: Springer 2013:3389-93
- Borkovec TD, & Nau, S. D. . Credibility of analogue therapy rationales. Journal of Behavior Therapy and Experimental Psychology 1972;3:257-60
- Simons LE, Vlaeyen JWS, Declercq L, Smith AM, Beebe J, Hogan M, Li E, Kronman CA, Mahmud F, Corey JR, Sieberg CB, Ploski C. Avoid or engage? Outcomes of graded exposure in youth with chronic pain using a sequential replicated single-case randomized design. Pain. 2020 Mar;161(3):520-531. doi: 10.1097/j.pain.0000000000001735.
- McCracken LM, Klock PA, Mingay DJ, Asbury JK, Sinclair DM. Assessment of satisfaction with treatment for chronic pain. J Pain Symptom Manage. 1997 Nov;14(5):292-9. doi: 10.1016/s0885-3924(97)00225-x.
- Harrison LE, Webster SN, Van Orden AR, Choate E, Jehl N, Stinson J, Wicksell RK, Bonnert M, Lalouni M, Darnall BD, Simons LE. Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy. BMJ Open. 2022 Sep 15;12(9):e065997. doi: 10.1136/bmjopen-2022-065997.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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