DepressionNCT05591937
S.T.A.N.D. Alacrity Center Signature Project
A study testing Self-Guided Online Prevention, Coach-Guided Online Cognitive Behavioral Therapy and Clinician-Delivered Psychological and Psychiatric Care in people with Depression and Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Self-Guided Online Prevention, Coach-Guided Online Cognitive Behavioral Therapy and Clinician-Delivered Psychological and Psychiatric Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alainna Wen, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
East Los Angeles College
Los Angeles, California, 91754
Areli Vargas, VARGASA3@ELAC.EDU
About this study
Official title: Screening and Treatment for Anxiety & Depression (S.T.A.N.D): Alacrity Center Signature Project on Triaging and Adapting to Level of Care
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Self-Guided Online Prevention, Coach-Guided Online Cognitive Behavioral Therapy, Clinician-Delivered Psychological and Psychiatric Care
- Keywords
- personalized care, cognitive behavioral therapy, depression, anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided Online PreventionBehavioural
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.
Coach-Guided Online Cognitive Behavioral TherapyBehavioural
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 (phone, tablet or computer) and speak to a certified student coach through remote video chat.
Clinician-Delivered Psychological and Psychiatric CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Symptom Severity Decision-Making | Active comparator | Using current symptom severity level to guide triaging and adapting level of care. Receives: Behavioral: Self-Guided Online Prevention; Behavioral: Coach-Guided Online Cognitive Behavioral Therapy; Behavioral: Clinician-Delivered Psychological and Psychiatric Care |
| 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. Receives: Behavioral: Self-Guided Online Prevention; Behavioral: Coach-Guided Online Cognitive Behavioral Therapy; Behavioral: Clinician-Delivered Psychological and Psychiatric Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal trajectory of treatment adherence
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.
Measured: Up to 40 weeks
Baseline symptom severity for mental health
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.
Measured: Baseline
Longitudinal trajectory of symptom severity for mental health
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.
Measured: Up to 40 weeks
Baseline social, occupational, and home functioning
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.
Measured: Baseline
Baseline academic functioning
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.
Measured: Baseline
Longitudinal trajectory of social, occupational, and home functioning
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.
Measured: Up to 40 weeks
Longitudinal trajectory of academic functioning
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.
Measured: Up to 40 weeks
Suicide and self-harm
Number of attempts of suicide and non-suicidal self harm (11 items, scored with yes/no). Higher scores reflect higher overall self harm risk.
Measured: Up to 40 weeks
Secondary outcomes (30)
Demographic background
Healthy Minds Survey: age, sex assigned at birth, gender identity, sexual orientation, race/ethnicity, citizenship/immigration status (1 item each).
Measured: Baseline
Language
Healthy Minds Survey: language most commonly spoken with friends (1 item).
Measured: Baseline
Acculturative Stress
Societal, Attitudinal, Familial and Environmental Acculturative Stress Scale: validated with Black, Latino and Asian American samples, particularly among college samples (6 items, scored on a 1 to 4 scale). Higher scores reflect greater acculturative stress.
Measured: Baseline
Major discrimination experiences
Major Experiences of Discrimination-Abbreviated: discrimination due to racial, ethnic, socioeconomic, gender or other reasons (12 items, scored on a 1 to 4 scale). Higher scores reflect more discrimination experiences.
Measured: Baseline
Longitudinal trajectory of daily discrimination experiences
Everyday Discrimination-Short Form: daily experiences of discrimination (6 items, scored on a 1 to 6 scale). Higher scores reflect more discrimination experiences. Measured longitudinally to capture trajectory over the course of the treatment.
Measured: Up to 40 weeks
Longitudinal trajectory of employment status
Healthy Minds Survey (1 item). Measured at baseline and longitudinally to capture value prior to beginning treatment and trajectory over the course of the treatment.
Measured: Up to 40 weeks
Longitudinal trajectory of housing/food security and financial stress
Assessment of food, housing, and financial needs (4 items, scored with 1 = yes and 0 = no). Higher scores reflect higher stress level. Measured at baseline and longitudinally to capture value prior to beginning treatment and trajectory over the course of the treatment.
Measured: Up to 40 weeks
Longitudinal trajectory of social support
Medical Outcomes Social Support Survey: perceived level of social support (4 items, scored on a 1 to 5 scale). Higher scores reflect higher support level. Measured at baseline and longitudinally to capture value prior to beginning treatment and trajectory over the course of the treatment.
Measured: Up to 40 weeks
Early adversity
Adverse Childhood Experiences Questionnaire: exposure to early life adversity and maltreatment (10 items, scored with 1 = yes and 0 = no). Higher scores reflect greater adversity.
Measured: Baseline
Life stress exposure
Youth Partners in Care Life Events Scale: exposure to 15 negative stressful life events in the past 6 months (18 items, scored with 1 = yes and 0 = no). Higher scores reflect more stress exposure.
Measured: Baseline
Longitudinal trajectory of perceived life stress
Perceived Stress Scale: exposure to ongoing life stress (1 item, scored on a 0 to 3 scale). Higher scores reflect greater perceived stress. Measured longitudinally to capture trajectory over the course of the treatment.
Measured: Up to 40 weeks
Beliefs about mental health treatment and stigma
Healthy Minds Survey: attitudes towards mental health treatment and perceived and personal stigma about receiving mental health treatment (8 items, scored on a 1 to 6 scale); adapted from the Perceived Devaluation-Discrimination scale. Higher scores reflect more stigmatizing beliefs.
Measured: Baseline
Insurance status
Healthy Minds Survey: insurance status (1 item).
Measured: Baseline
Willingness to pay
Modified Willingness to Pay Scale: maximum yearly amount that one is willing to pay for mental health treatment (1 item).
Measured: Baseline
Perceived need
Healthy Minds Survey: perceived need for mental health services (1 item, scored on a 1 to 6 scale). Higher scores reflect lower perceived need.
Measured: Baseline
Longitudinal trajectory of sleep quality
Insomnia Severity Index: level of sleep quality and severity of insomnia (7 items, scored on a 1 to 5 scale). Higher scores reflect greater insomnia severity. Measured at baseline and longitudinally to capture value prior to beginning treatment and trajectory over the course of the treatment.
Measured: Up to 40 weeks
Longitudinal trajectory of substance use
Computerized Adaptive Test - Substance Use Inventory (CAT-SUD). Symptoms 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 substance use severity. Measured at baseline and longitudinally to capture value prior to beginning treatment and trajectory over the course of the treatment.
Measured: Up to 40 weeks
Other mental conditions
Screening Assessment for Guiding Evaluation-Self Report (SAGE-SR): computerized self-report assessment of Diagnostic Statistical Manual-5 (DSM-5) diagnoses.
Measured: Baseline
Other medical conditions
Healthy Minds Survey: physical health (1 item).
Measured: Baseline
Emotion dysregulation
Difficulties in Emotion Regulation Scale-Short Form: self-report of emotion dysregulation or affective instability, a trait associated with many forms of psychopathology and personality disorders (16 items, scored on a 1 to 5 scale). Higher scores reflect greater emotion dysregulation.
Measured: Baseline
Verbal ability
The Vocabulary Test: a measure of verbal ability that correlates with Scholastic Aptitude Test (SAT) verbal scores. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Abstract reasoning
The Matrix Reasoning Test: a measure of intelligence quotient (IQ) and abstract reasoning that correlates with the SAT math scores. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Cognitive response
The Choice Reaction Time Test: a measure of cognitive processing, response selection and inhibition aspects of cognitive control. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Selective attention
The Gradual Onset Continuous Performance Test: a measure of sustained attention and response inhibition. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Processing speed
Digit Symbol Matching Test: a measure of processing speed. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Visuospatial information processing
Multiple Object Tracking Test: a measure of visuospatial attention and visual working memory. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Socioemotional information processing
Multiracial Emotion Identification Test: a measure of emotion recognition and social perception. Administered digitally through the TestMyBrain neurocognitive test battery, which has been shown to have adequate psychometric properties according to the National Institutes of Health report. Higher scores reflect greater functioning in this domain.
Measured: Baseline
Mental health treatment history
Healthy Minds Survey: prior therapy, medications, and helpfulness (4 items).
Measured: Baseline
Mental health treatment preference
Preference Scale: preference for online vs. clinician-delivered therapy (1 item).
Measured: Baseline
Longitudinal trajectory of regulatory strategy use
Modified brief cognitive emotion regulation questionnaire: self-report of emotion regulatory strategy use (9 items, scored on a 1 to 5 scale). Higher scores reflect more frequent use of regulatory strategies. Measured at baseline and longitudinally to capture value prior to beginning treatment and trajectory over the course of the treatment.
Measured: Up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start29 Aug 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Craske, University of California, Los Angeles
- Investigators
- Michelle Craske, Ph.D, Principal investigator, University of California, Los AngelesKate Taylor, Ph.D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591937
- Sponsor's protocol ID
- P50MH126337
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37553688
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Treatment for Anxiety & Depression (S.T.A.N.D): Alacrity Center Signature Project on Triaging and Adapting to Level of Care
- ClinicalTrials.gov ID
- NCT05591937
- Acronym / sponsor ID
- P50MH126337
- Conditions
- Depression, Anxiety
- Keywords
- personalized care, cognitive behavioral therapy, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom Severity Decision-Making | Active comparator | Behavioral: Self-Guided Online Prevention, Behavioral: Coach-Guided Online Cognitive Behavioral Therapy, Behavioral: Clinician-Delivered Psychological and Psychiatric CareUsing current symptom severity level to guide triaging and adapting level of care. |
| Data-Driven Decision-Making | Experimental | Behavioral: Self-Guided Online Prevention, Behavioral: Coach-Guided Online Cognitive Behavioral Therapy, Behavioral: Clinician-Delivered Psychological and Psychiatric CareUsing 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Guided Online PreventionAn 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. | Behavioural | Data-Driven Decision-Making, Symptom Severity Decision-Making |
| Coach-Guided Online Cognitive Behavioral TherapyAn 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 (phone, tablet or computer) and speak to a certified student coach through remote video chat. | Behavioural | Data-Driven Decision-Making, Symptom Severity Decision-Making |
| Clinician-Delivered Psychological and Psychiatric CareEvidence-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. | Behavioural | Data-Driven Decision-Making, Symptom Severity Decision-Making |
Primary outcome
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 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.
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.
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 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.
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.
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.
30 secondary outcomes
Demographic background
Time frame: Baseline
Language
Time frame: Baseline
Acculturative Stress
Time frame: Baseline
Major discrimination experiences
Time frame: Baseline
Longitudinal trajectory of daily discrimination experiences
Time frame: Up to 40 weeks
Longitudinal trajectory of employment status
Time frame: Up to 40 weeks
Longitudinal trajectory of housing/food security and financial stress
Time frame: Up to 40 weeks
Longitudinal trajectory of social support
Time frame: Up to 40 weeks
Early adversity
Time frame: Baseline
Life stress exposure
Time frame: Baseline
Longitudinal trajectory of perceived life stress
Time frame: Up to 40 weeks
Beliefs about mental health treatment and stigma
Time frame: Baseline
Insurance status
Time frame: Baseline
Willingness to pay
Time frame: Baseline
Perceived need
Time frame: Baseline
Longitudinal trajectory of sleep quality
Time frame: Up to 40 weeks
Longitudinal trajectory of substance use
Time frame: Up to 40 weeks
Other mental conditions
Time frame: Baseline
Other medical conditions
Time frame: Baseline
Emotion dysregulation
Time frame: Baseline
Verbal ability
Time frame: Baseline
Abstract reasoning
Time frame: Baseline
Cognitive response
Time frame: Baseline
Selective attention
Time frame: Baseline
Processing speed
Time frame: Baseline
Visuospatial information processing
Time frame: Baseline
Socioemotional information processing
Time frame: Baseline
Mental health treatment history
Time frame: Baseline
Mental health treatment preference
Time frame: Baseline
Longitudinal trajectory of regulatory strategy use
Time frame: Up to 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 37553688Wen 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.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alainna Wen, Ph.D. contact
Michelle Craske, Ph.D principal investigator
University of California, Los Angeles
Kate Taylor, Ph.D principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided Online Prevention, Coach-Guided Online Cognitive Behavioral Therapy and Clinician-Delivered Psychological and Psychiatric Care in people with Depression and Anxiety, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelia Welborn, Ph.D. (916-202-5952, awelborn@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal trajectory of treatment adherence (time frame: Up to 40 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.