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

Depression Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591937
• Other study ID #: P50MH126337
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: Andrew J Sanders, Ph.D.
• Phone: 310-206-4662
• Email: ajsanders[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
United States	East Los Angeles College	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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