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Идёт набор NCT05591937

S.T.A.N.D. Alacrity Center Signature Project

Без фазы С лечением Depression Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Self-Guided Online Prevention, Coach-Guided Online Cognitive Behavioral Therapy, Clinician-Delivered Psychological and Psychiatric Care.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Screening and Treatment for Anxiety & Depression (S.T.A.N.D): Alacrity Center Signature Project on Triaging and Adapting to Level of Care

Обзор

The purpose of this study is to evaluate clinical decision-making algorithms for (a) triaging to level of care and (b) adapting level of care in a low income, highly diverse sample of community college students at East Los Angeles College (ELAC). The target enrollment is 200 participants per year, for five years (N=1000). Participants are between the ages of 18 and 40 years and will be randomized into either symptom severity decision-making (SSD) or data-driven decision-making (DDD). Participants in each condition will be triaged to one of three levels of care, including self-guided online prevention, coach-guided online cognitive behavioral therapy, and clinician-delivered care. After initial triaging, level of care will be adapted throughout the entire time of the study enrollment. Participants will complete computerized assessments and self-report questionnaires as part of the study. The total length of participation is 40 weeks.

Подробное описание

Community colleges provide a critical pathway for workforce development and socio-economic gain, but this opportunity is mitigated by unmet need for mental health services, particularly for depression and anxiety, and particularly for racial/ethnic minority students. A scalable and effective system of care that manages mental health needs in concert with social mental health determinants is sorely needed. The Alacrity Center aims to implement the STAND system of care, which screens and treats anxiety and depression, for a highly diverse community college population. STAND triages to various level of care, ranging from self-guided online prevention, to coach-guided online cognitive behavioral therapy (CBT), to clinician-delivered care. After initial triaging, STAND makes adaptations to level of care throughout the entire time of study enrollment (e.g., moved up to a higher level of care during acute treatment). These triaging and adaptation decisions currently are based on current symptom severity. Such decisions can be optimized by comprehensive data-driven algorithms that predict the need for a particular level of care and for adaptation to level of care throughout treatment, and especially algorithms that are suited to the needs of underserved community college students who face substantial life stressors.

The overarching aim of the Signature Project is to evaluate clinical decision-making algorithms for (a) triaging to level of care and (b) adapting level of care in a low income, highly diverse sample of community college students at East Los Angeles College (ELAC). The end goal is to improve the effectiveness of STAND and to advance the science of personalized mental health. To do this, we will compare the standard approach that relies solely upon symptom severity to a data-driven approach to decision making that uses multivariate predictive algorithms comprised of baseline static and time-varying features from four overlapping and mutually reinforcing theoretical constructs: (1) social determinants of mental health (employment, income, housing \& food security, discrimination, social support, race/ethnicity, acculturation, immigration status, gender, sexual orientation); (2) early adversity and life stressors; (3) predisposing, enabling and need influences upon health services use; and (4) comprehensive mental health status (depression, anxiety and suicide severity, comorbidities, neurocognitive functioning, emotion dysregulation, regulatory strategy use, treatment history and preferences, social, occupational, home and academic functioning). The overarching design is to randomize ELAC students to either symptom severity decision-making (SSD) or data-driven decision-making (DDD), and evaluate whether DDD improves adherence to treatment, symptoms, and functioning. Other aims of this project are to (a) identify distal and proximal risk factors for suicide and self-harm and (b) examine effects of the decision-making condition (SSD, DDD) on suicidality and self-harm outcomes.

Participants will be enrolled through recruitment efforts at ELAC. The target enrollment is 200 participants per year over five years (n = 1000 total). Participants are current ELAC student between the ages of 18-40. Predictors and outcomes will be assessed at baseline and either weekly or every 8 weeks until week 40. Multivariate prediction models will be used for initial level of care triaging and later adaptations of level of care based on a comprehensive set of variables that have been shown to drive current mental health needs. Participants will complete computerized assessments and self-report questionnaires. The total length of participation is 40 weeks.

Embedded components:

Component 1 to evaluate interventions aimed at improving STAND uptake: In October 2025 an embedded randomized component was launched within this parent trial to evaluate approaches for improving initial uptake and engagement with STAND at ELAC. Participants consented to the parent trial are additionally randomized 1:1:1 to receive one of 3 engagement intervention conditions: either 1) fotonovela 2) peer-led engagement navigator 3) enrollment as usual. There is no separate consent process nor additional eligibility criteria for this embedded component. Only participants consented to the Signature project are enrolled in this additional component.

Component 2 to evaluate evaluate a technology-enhanced suicide prevention intervention (TE-SPI): In July 2025 the project launched an embedded RCT to evaluate a technology-enhanced suicide prevention intervention (TE-SPI) that includes treatment components with demonstrated benefits in prior research (safety planning, BRITE app, caring contacts to support safety plan use, hope, and reasons for living) and leverages mobile technology to deliver just-in-time adaptive interventions when intervention is most needed. Using Tier II and Tier III participants consented to the Signature Project, which include students for whom additional intervention for SU/SH risk is indicated, this work will use a rapid prototyping and testing model to develop and test an adaptation of the existing BRITE app plus safety planning for the primarily Latinx ELAC population. We are randomizing consented Tier II and Tier III assigned Signature Project participants to evaluate 1) TE-SPI with STAND usual risk management protocol (URM) compared to 2) STAND URM alone. We hypothesize that TE-SPI will a) lead to increased treatment engagement/contacts (i.e. app, STAND); b) demonstrate safety as indicated by low levels of self-harm related adverse events (e.g. hospitalizations, ED visits); c) be associated with fewer SU/SH events and greater improvement in suicidality, compared to URM; and d) that intervention engagement/dose received will lead to reduced SU/SH behavior.

Вмешательства

  • Поведенческое Self-Guided Online Prevention
    An online wellness program that contains self-guided online CBT prevention strategies with demonstrated efficacy for depression and anxiety in college samples. Participants can learn skills for coping with common stressful experiences and build resilience at their own pace.
  • Поведенческое Coach-Guided Online Cognitive Behavioral Therapy
    An online digital therapy program that consists of online CBT modules supported by coaches through video chats. The modules are evidence-based and formatted into a unified approach for depression, anxiety and worry, panic, social anxiety, trauma and sleep dysregulation (developed as part of the University of California, Los Angeles (UCLA) Depression Grand Challenge). Lessons are designed to respond to participants' specific symptoms. Participants can access the system through any personal device
  • Поведенческое Clinician-Delivered Psychological and Psychiatric Care
    Evidence-based clinician-delivered CBT modules. Participants are connected to a team of clinicians who will evaluate participants' specific symptoms and create an individualized and tailored treatment plan. Treatment will include weekly sessions delivered through telehealth, and if deemed appropriate, participants may also have medication appointments.

Первичные конечные точки

  • Longitudinal trajectory of treatment adherence [Срок оценки: Up to 40 weeks]
  • Baseline symptom severity for mental health [Срок оценки: Baseline]
  • Longitudinal trajectory of symptom severity for mental health [Срок оценки: Up to 40 weeks]
  • Baseline social, occupational, and home functioning [Срок оценки: Baseline]
  • Baseline academic functioning [Срок оценки: Baseline]
  • Longitudinal trajectory of social, occupational, and home functioning [Срок оценки: Up to 40 weeks]
  • Longitudinal trajectory of academic functioning [Срок оценки: Up to 40 weeks]
  • Suicide and self-harm [Срок оценки: Up to 40 weeks]
Вторичные конечные точки (12)
  • Demographic background [Срок оценки: Baseline]
  • Language [Срок оценки: Baseline]
  • Acculturative Stress [Срок оценки: Baseline]
  • Major discrimination experiences [Срок оценки: Baseline]
  • Longitudinal trajectory of daily discrimination experiences [Срок оценки: Up to 40 weeks]
  • Longitudinal trajectory of employment status [Срок оценки: Up to 40 weeks]
  • Longitudinal trajectory of housing/food security and financial stress [Срок оценки: Up to 40 weeks]
  • Longitudinal trajectory of social support [Срок оценки: Up to 40 weeks]
  • Early adversity [Срок оценки: Baseline]
  • Life stress exposure [Срок оценки: Baseline]
  • Longitudinal trajectory of perceived life stress [Срок оценки: Up to 40 weeks]
  • Beliefs about mental health treatment and stigma [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Currently enrolled in the East Los Angeles College
  • Either uninsured or covered by California Medicaid
  • Own or have private access to internet to complete the assessments and online prevention and therapy programs

Критерии исключения

  • Unable to fully comprehend the consent form, respond adequately to screening questions, or maintain focus or to sit still during assessment
  • Diagnosed with disorders requiring more specialized care (e.g., psychotic disorder, severe eating disorder, severe substance use disorder, severe neurological disorder), or marked cognitive impairment
  • Currently treated by psychiatrist or psychologist during timeframe that the treatment is offered through STAND and is unwilling to fully transfer care to STAND

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • East Los Angeles College — Los Angeles

Публикации

  • Wen A, Wolitzky-Taylor K, Gibbons RD, Craske M. A randomized controlled trial on using predictive algorithm to adapt level of psychological care for community college students: STAND triaging and adapting to level of care study protocol. Trials. 2023 Aug 9;24(1):508. doi: 10.1186/s13063-023-07441-7. PMID 37553688

Идентификаторы

NCT: NCT05591937 · P50MH126337

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗