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Clinical Trials/NCT05591937
NCT05591937
Recruiting
N/A

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 site in 1 country1,000 target enrollmentAugust 29, 2022

Overview

Phase
N/A
Intervention
Self-Guided Online Prevention
Conditions
Depression
Sponsor
University of California, Los Angeles
Enrollment
1000
Locations
1
Primary Endpoint
Suicide and self-harm
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 29, 2022
End Date
April 30, 2027
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Craske

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Arms & Interventions

Symptom Severity Decision-Making

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

Intervention: Self-Guided Online Prevention

Symptom Severity Decision-Making

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

Intervention: Coach-Guided Online Cognitive Behavioral Therapy

Symptom Severity Decision-Making

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

Intervention: Clinician-Delivered Psychological and Psychiatric Care

Data-Driven Decision-Making

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.

Intervention: Self-Guided Online Prevention

Data-Driven Decision-Making

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.

Intervention: Coach-Guided Online Cognitive Behavioral Therapy

Data-Driven Decision-Making

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.

Intervention: Clinician-Delivered Psychological and Psychiatric Care

Outcomes

Primary Outcomes

Suicide and self-harm

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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