- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07851792
Partial Digitalization of Mission ReST
Partial Digitalization and Pragmatic Evaluation of Mission ReST Using AI-Based Recommendation System: A Pragmatic, Preference-Based, Open-Label, Non-Randomized Trial
The goal of this non-randomized trial is to partially digitalize and develop a web-based resilience-building intervention and pilot-test its feasibility, acceptability, and appropriateness in an undergraduate sample over a 6-month implementation period. The main questions it aims to answer are:
- What are the rates of recruitment, adoption, and full program completion?
- What is the intervention's overall effectiveness in enhancing resilience and mental health outcomes?
Researchers will compare the partially digitalized intervention with a structurally equivalent in-person mode of delivery.
연구 개요
상태
정황
상세 설명
INTRODUCTION
Resilience is a well-established protective factor against stress and the development of mental health problems in young people. Prior work suggests that resilient responses to stressors are shaped, in part, by earlier experiences of navigating challenges and adversity in childhood. To address the limitations of one-size-fits-all resilience interventions, our research team developed Mission ReST, a person-specific, context-dependent program that tailors resilience-building strategies to individuals' response typologies to adversity.
Mission ReST is a three-session, face-to-face, gamified intervention that combines psychoeducation, skill practice, and experiential learning. Session 1 is a 60-minute individual self-discovery meeting with a trained facilitator, during which personalized recommendations for resilience-building strategies are introduced. Sessions 2 and 3 are 90-minute group sessions that use game-based challenges to help participants consolidate and apply resilience skills.
Preliminary findings suggest that the program is effective as a universal intervention and may be particularly beneficial for students with lower resilience or higher distress, with strongly positive student feedback. To further improve accessibility and engagement, this study digitalizes Session 1 into an interactive online component to scale up Mission ReST and support broader dissemination in other youth-serving settings.
AIMS AND OBJECTIVES
This study aims to (1) Develop a digitalized individual component of an existing personalized resilience-building program for university students, namely Session 1 of Mission ReST, with an AI-based recommendation system embedded, (2) Assess the feasibility, acceptability, and appropriateness of the digitalized individual component, and (3) Compare recruitment, adoption, rates of full program completion, and student outcomes between digital versus in-person delivery of the individual component over a 6-month implementation period.
METHOD
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INTERVENTION CONDITIONS Mission ReST is a psychoeducational intervention grounded in socialization to the resilience model and a library of 29 evidence-based resilience-building strategies targeting three core domains: negative self-concept, emotional dysregulation, and interpersonal functioning. In the experimental arm, these materials are delivered through an interactive web app. Based on users' assessment responses (i.e., multiple choice and free-text questions), an integrated AI-based recommender system using a hybrid filtering approach will identify and deliver suitable strategies. The active comparator arm involves in-person delivery of structurally and time-equivalent modules. Instead of AI-based recommendation, a trained facilitator will deliver the strategies after hearing the user's concerns.
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STUDY DESIGN Effectiveness of the digitalized version will be evaluated against the in-person delivery mode using a pragmatic, preference-based, open-label, non-randomized trial over a 6-month implementation period. This design prioritizes external validity and provides insight into program effectiveness, system capacity, dissemination, and scalability. The preference-based approach also allows assessment of delivery preferences and participation trends, aligns with evidence supporting flexible delivery modes for young people's mental health interventions, and reflects the trauma-informed care principle of offering choice.
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PARTICIPANTS AND PROCEDURES Undergraduates at PolyU between ages 18-24 years meeting the eligibility criteria will be recruited. Consistent with pragmatic trial methodology, which supports broad inclusion, ongoing recruitment efforts, and the scalability of digital delivery of Session 1, at least 400 students will be recruited during the implementation period.
After providing consent to participate, students will provide baseline data on demographic information (age, gender, study discipline), current mental health status (DASS-21 for anxiety, depression, and stress), perceived resilience (BRS), and disturbances in self-organization (ITQ-DSO). Students may then choose to complete Session 1 either in person with a Mission ReST trainer or through the online digital component. Delivery-mode preference and Session 1 completion will be recorded, after which both arms of students will proceed to the two subsequent in-person group sessions. Three attempts will be made to contact and schedule the students to join the group sessions; non-response from three attempts is considered loss to dropout. Students will complete the outcome measures again immediately after full program completion (i.e., end of Session 3). All surveys will be completed online using Qualtrics.
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OUTCOME MEASURES Primary outcomes include implementation and feasibility metrics (recruitment and retention rate and satisfaction for both delivery mode over the implementation period). Secondary outcomes include baseline and post-intervention data on resilience (BRS), depression, anxiety, and stress (DASS-21), and disturbances in self-organization (ITQ-DSO). Baseline demographic information and adverse childhood experiences (ACEs) will also be collected to characterize the sample.
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DATA ANALYSIS Implementation and feasibility metrics will be summarized using descriptive statistics, including characteristics of screened and enrolled students, and their preference for and adoption of digital versus in-person delivery of Mission ReST Session 1. Completion, attrition, and group differences will be analyzed using t-tests, ANOVA, or chi-square tests as appropriate. To assess effectiveness between groups, changes in BRS, DASS-21 and ITQ-DSO scores from pre- to post-intervention will be examined using factorial repeated-measures ANOVA. Differences by delivery mode will be further explored using multiple linear regression with gain scores, adjusting for age, gender, and baseline scores. Intention-to-treat principles will be applied, with missing data addressed through multiple imputation. Sensitivity analyses will test alternative imputation methods, complete-case analysis, and subgroup effects by student characteristics.
ETHICAL CONSIDERATIONS
Approval has been obtained from the Human Subjects Ethics Sub-Committee of the University (HSEARS20251216001). Students will provide written informed consent to participate and will also sign the Confidentiality and Service Agreements. All Mission ReST trainers have received training in trauma-informed care and in identifying and supporting students experiencing mental distress. ReST Hub has an established crisis management protocol and works closely with University Health Services and PolyU Counselling and Wellness. Students at imminent risk will be immediately referred for professional support through the existing response system, and the PI will be notified. Data confidentiality will be strictly protected, with identifiable information stored separately from research data and all files kept securely in encrypted and locked storage. Only research team members will have access to the raw data.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Bryan Yu, PhD
- 전화번호: +852 27666541
- 이메일: bryan-hw.yu@polyu.edu.hk
연구 장소
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Hong Kong, 홍콩
- School of Nursing, The Hong Kong Polytechnic University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Undergraduate at PolyU
- Able to provide informed consent
- Report normal to moderate levels of distress as measured by DASS-21
Exclusion Criteria:
- Severe or higher levels of mental distress as measured by DASS-21
- Self-report diagnosis of mental illness
- Currently receiving professional mental health services
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Digitalized, AI-based web app
In the experimental arm, materials of the resilience-building psychoeducation are delivered through an interactive web app. Based on users' assessment responses (i.e., multiple choice and free-text questions), an integrated AI-based recommender system using a hybrid filtering approach will identify and deliver suitable resilience-building strategies. |
The interactive web app is integrated with an AI-based recommender system using a hybrid filtering approach that will identify and deliver suitable strategies based on users' assessment responses (i.e., multiple choice and free-text questions). |
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활성 비교기: In-person delivery
In the active comparator arm, the structurally and time-equivalent modules are delivered by trained facilitators. |
Structurally and time equivalent to the digital version of Mission ReST Session 1, delivered by a trained facilitator after assessing the participant's concerns and responses. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of the digitalized individual components
기간: From baseline to end of intervention at 6 weeks
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Proportion of eligible individuals who consent, participate, and complete the intervention |
From baseline to end of intervention at 6 weeks
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Acceptability of the digitalized individual components
기간: From baseline to end of intervention at 6 weeks
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Quantitative measure of participant satisfaction based on a 5-point Likert scale ranging from "1=Very Dissatisfied" to "5=Very Satisfied," and qualitative description of participants' perspectives on acceptability of the intervention. |
From baseline to end of intervention at 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Resilience
기간: From baseline to end of follow-up assessment at 10 weeks
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The Brief Resilience Scale (BRS), a 6-item self-report questionnaire that measures perceived ability to bounce back from adversity will be used. Responses are provided on a 5-point Likert scale ranging from "strongly disagree=1" to "strongly agree=5." Scores are calculated based on the average of the 6 items, with cut-offs defined as low resilience (1-2.99), normal (3-4.30), and high (4.31-5.0). The Chinese BRS demonstrated good internal consistency, criterion validity, and construct validity when applied in university undergraduate students (Fung, 2020). |
From baseline to end of follow-up assessment at 10 weeks
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Depression, anxiety, and stress
기간: From baseline to end of follow-up assessment at 10 weeks
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The Depression Anxiety and Stress scale (DASS-21; Henry & Crawford, 2005) will be used to assess depression, anxiety, and stress levels. The scale comprises 21 items (seven items each), each rated on a 4-point scale from 0 ('Did not apply to me at all') to 3 ('Applied to me very much or most of the time'). The DASS-21 has demonstrated sound psychometric properties across a range of clinical and non-clinical populations, including good internal consistency and concurrent validity with the original DASS-42 (Antony et al., 1998). |
From baseline to end of follow-up assessment at 10 weeks
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Disturbances in self-organization
기간: From baseline to end of follow-up assessment at 10 weeks
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The Disturbances in Self-Organization subscale of the International Trauma Questionnaire (ITQ; Cloitre et al., 2018) will be used to assess affective dysregulation, negative self-concept, and disturbed relationships. The ITQ has demonstrated good psychometric properties in Hong Kong University student samples (Ho, Karatzias, et al., 2019). |
From baseline to end of follow-up assessment at 10 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Grace WK Ho, PhD, The Hong Kong Polytechnic University
간행물 및 유용한 링크
일반 간행물
- Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
- Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.
- Masten AS, Lucke CM, Nelson KM, Stallworthy IC. Resilience in Development and Psychopathology: Multisystem Perspectives. Annu Rev Clin Psychol. 2021 May 7;17:521-549. doi: 10.1146/annurev-clinpsy-081219-120307. Epub 2021 Feb 3.
- Ho GWK, Karatzias T, Cloitre M, Chan ACY, Bressington D, Chien WT, Hyland P, Shevlin M. Translation and validation of the Chinese ICD-11 International Trauma Questionnaire (ITQ) for the Assessment of Posttraumatic Stress Disorder (PTSD) and Complex PTSD (CPTSD). Eur J Psychotraumatol. 2019 May 15;10(1):1608718. doi: 10.1080/20008198.2019.1608718. eCollection 2019.
- Achilles MR, Anderson M, Li SH, Subotic-Kerry M, Parker B, O'Dea B. Adherence to e-mental health among youth: Considerations for intervention development and research design. Digit Health. 2020 May 21;6:2055207620926064. doi: 10.1177/2055207620926064. eCollection 2020 Jan-Dec.
- Handley MA, Lyles CR, McCulloch C, Cattamanchi A. Selecting and Improving Quasi-Experimental Designs in Effectiveness and Implementation Research. Annu Rev Public Health. 2018 Apr 1;39:5-25. doi: 10.1146/annurev-publhealth-040617-014128. Epub 2018 Jan 12.
- Hedberg EC, Ayers S. The power of a paired t-test with a covariate. Soc Sci Res. 2015 Mar;50:277-91. doi: 10.1016/j.ssresearch.2014.12.004. Epub 2014 Dec 17.
- Karatzias T, Mc Glanaghy E, Cloitre M. Enhanced Skills Training in Affective and Interpersonal Regulation (ESTAIR): A New Modular Treatment for ICD-11 Complex Posttraumatic Stress Disorder (CPTSD). Brain Sci. 2023 Sep 9;13(9):1300. doi: 10.3390/brainsci13091300.
- Abulfaraj GG, Upsher R, Zavos HMS, Dommett EJ. The Impact of Resilience Interventions on University Students' Mental Health and Well-Being: A Systematic Review. Educ Sci. 2024;14(5)doi:10.3390/educsci14050510
- Ang WHD, Lau ST, Cheng LJ, et al. Effectiveness of resilience interventions for higher education students: A meta-analysis and metaregression. J Educ Psychol. 2022;114(7):1670-1694. doi:10.1037/edu0000719
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- HSEARS20251216001
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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