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

Study 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. Recruitment will take place in the first two to four months of each academic year. 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 in the first two to four months of the academic year 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.

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

Conditions
-----------------
Anxiety, Depression

Intervention / Treatment
-----------------
* Behavioral: Self-Guided Online Prevention
* Behavioral: Coach-Guided Online Cognitive Behavioral Therapy
* Behavioral: Clinician-Delivered Psychological and Psychiatric Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Symptom Severity Decision-Making<br>Using current symptom severity level to guide triaging and adapting level of care. | Behavioral: Self-Guided Online Prevention<br>* 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.<br>Behavioral: Coach-Guided Online Cognitive Behavioral Therapy<br>* 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.<br>Behavioral: Clinician-Delivered Psychological and Psychiatric Care<br>* 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.<br>|
| Experimental: Data-Driven Decision-Making<br>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. | Behavioral: Self-Guided Online Prevention<br>* 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.<br>Behavioral: Coach-Guided Online Cognitive Behavioral Therapy<br>* 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.<br>Behavioral: Clinician-Delivered Psychological and Psychiatric Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Up to 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic background | Healthy Minds Survey: age, sex assigned at birth, gender identity, sexual orientation, race/ethnicity, citizenship/immigration status (1 item each). | Baseline | 
| Language | Healthy Minds Survey: language most commonly spoken with friends (1 item). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline | 
| Insurance status | Healthy Minds Survey: insurance status (1 item). | Baseline | 
| Willingness to pay | Modified Willingness to Pay Scale: maximum yearly amount that one is willing to pay for mental health treatment (1 item). | 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. | 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. | 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. | 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. | Baseline | 
| Other medical conditions | Healthy Minds Survey: physical health (1 item). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline | 
| Mental health treatment history | Healthy Minds Survey: prior therapy, medications, and helpfulness (4 items). | Baseline | 
| Mental health treatment preference | Preference Scale: preference for online vs. clinician-delivered therapy (1 item). | 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. | Up to 40 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
personalized care, cognitive behavioral therapy, depression, anxiety