跳至主要内容
临床试验/NCT05591937
NCT05591937招募中不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年8月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Suicide and self-harm

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Symptom Severity Decision-Making

Active Comparator

Using current symptom severity level to guide triaging and adapting level of care.

干预措施: Self-Guided Online Prevention (Behavioral)

Symptom Severity Decision-Making

Active Comparator

Using current symptom severity level to guide triaging and adapting level of care.

干预措施: Coach-Guided Online Cognitive Behavioral Therapy (Behavioral)

Symptom Severity Decision-Making

Active Comparator

Using current symptom severity level to guide triaging and adapting level of care.

干预措施: Clinician-Delivered Psychological and Psychiatric Care (Behavioral)

Data-Driven Decision-Making

Experimental

Using data-driven algorithm that considers social determinants of mental health, early life adversity/stress, predisposing, enabling and need influences upon health services use, and comprehensive mental health status to guide triaging and adapting level of care.

干预措施: Self-Guided Online Prevention (Behavioral)

Data-Driven Decision-Making

Experimental

Using data-driven algorithm that considers social determinants of mental health, early life adversity/stress, predisposing, enabling and need influences upon health services use, and comprehensive mental health status to guide triaging and adapting level of care.

干预措施: Coach-Guided Online Cognitive Behavioral Therapy (Behavioral)

Data-Driven Decision-Making

Experimental

Using data-driven algorithm that considers social determinants of mental health, early life adversity/stress, predisposing, enabling and need influences upon health services use, and comprehensive mental health status to guide triaging and adapting level of care.

干预措施: Clinician-Delivered Psychological and Psychiatric Care (Behavioral)

结局指标

主要结局

Suicide and self-harm

时间窗: Up to 40 weeks

Number of attempts of suicide and non-suicidal self harm (11 items, scored with yes/no). Higher scores reflect higher overall self harm risk.

Baseline symptom severity for mental health

时间窗: Baseline

Computerized Adaptive Test - Mental Health (CAT-MH). Symptoms of depression and anxiety are assessed using item response theory (IRT), where a subset of items are selected from a pool of approximately 1000 questions based on participant impairment level. Higher scores reflect greater symptom severity. Measured prior to beginning treatment to capture baseline value.

Longitudinal trajectory of symptom severity for mental health

时间窗: Up to 40 weeks

Computerized Adaptive Test - Mental Health (CAT-MH). Symptoms of depression and anxiety are assessed using item response theory (IRT), where a subset of items are selected from a pool of approximately 1000 questions based on participant impairment level. Higher scores reflect greater symptom severity. Measured longitudinally to capture trajectory over the course of the treatment.

Longitudinal trajectory of academic functioning

时间窗: Up to 40 weeks

Healthy Minds Survey: grade point average and perceived impact of mental health on academic functioning (1 item each, scored on a 1 to 4 scale). Higher scores reflect poorer academic functioning. Measured longitudinally to capture trajectory over the course of the treatment.

Baseline academic functioning

时间窗: Baseline

Healthy Minds Survey: grade point average and perceived impact of mental health on academic functioning (1 item each, scored on a 1 to 4 scale). Higher scores reflect poorer academic functioning. Measured prior to beginning treatment to capture baseline value.

Longitudinal trajectory of treatment adherence

时间窗: Up to 40 weeks

Number of clinician sessions or coaching lessons attended or the number of online lessons completed; number of missed/cancelled sessions with clinicians or coaches; number of times logged on and total time spent online (1 item each). Measured longitudinally to capture trajectory over the course of the treatment.

Baseline social, occupational, and home functioning

时间窗: Baseline

Work and Social Adjustment Scale: functioning at work/school, home, social, and leisure activities (5 items, scored on a 0 to 8 scale). Higher scores reflect better adjustment. Measured prior to beginning treatment to capture baseline value.

Longitudinal trajectory of social, occupational, and home functioning

时间窗: Up to 40 weeks

Work and Social Adjustment Scale: functioning at work/school, home, social, and leisure activities (5 items, scored on a 0 to 8 scale). Higher scores reflect better adjustment. Measured longitudinally to capture trajectory over the course of the treatment.

次要结局

  • Longitudinal trajectory of substance use(Up to 40 weeks)
  • Language(Baseline)
  • Major discrimination experiences(Baseline)
  • Longitudinal trajectory of employment status(Up to 40 weeks)
  • Early adversity(Baseline)
  • Perceived need(Baseline)
  • Acculturative Stress(Baseline)
  • Longitudinal trajectory of housing/food security and financial stress(Up to 40 weeks)
  • Longitudinal trajectory of perceived life stress(Up to 40 weeks)
  • Insurance status(Baseline)
  • Visuospatial information processing(Baseline)
  • Demographic background(Baseline)
  • Longitudinal trajectory of social support(Up to 40 weeks)
  • Life stress exposure(Baseline)
  • Beliefs about mental health treatment and stigma(Baseline)
  • Willingness to pay(Baseline)
  • Longitudinal trajectory of sleep quality(Up to 40 weeks)
  • Other medical conditions(Baseline)
  • Mental health treatment preference(Baseline)
  • Longitudinal trajectory of daily discrimination experiences(Up to 40 weeks)
  • Other mental conditions(Baseline)
  • Emotion dysregulation(Baseline)
  • Cognitive response(Baseline)
  • Selective attention(Baseline)
  • Abstract reasoning(Baseline)
  • Socioemotional information processing(Baseline)
  • Verbal ability(Baseline)
  • Processing speed(Baseline)
  • Mental health treatment history(Baseline)
  • Longitudinal trajectory of regulatory strategy use(Up to 40 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michelle Craske

Principal Investigator

University of California, Los Angeles

研究点 (1)

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