Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2022-08-29
2027-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Symptom Severity Decision-Making
Using current symptom severity level to guide triaging and adapting level of care.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Michelle Craske
Principal Investigator
Principal Investigators
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Michelle Craske, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Kate Taylor, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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East Los Angeles College
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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