Clinical trial NCT05591937: S.T.A.N.D. Alacrity Center Signature Project
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: personalized care
cognitive behavioral therapy
depression
anxiety
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Longitudinal trajectory of treatment adherence
timeFrame: Up to 40 weeks
measure: Baseline symptom severity for mental health
timeFrame: Baseline
measure: Longitudinal trajectory of symptom severity for mental health
timeFrame: Up to 40 weeks
measure: Baseline social, occupational, and home functioning
timeFrame: Baseline
measure: Baseline academic functioning
timeFrame: Baseline
measure: Longitudinal trajectory of social, occupational, and home functioning
timeFrame: Up to 40 weeks
measure: Longitudinal trajectory of academic functioning
timeFrame: Up to 40 weeks
measure: Suicide and self-harm
timeFrame: Up to 40 weeks
Secondary outcomes:
measure: Demographic background
timeFrame: Baseline
measure: Language
timeFrame: Baseline
measure: Acculturative Stress
timeFrame: Baseline
measure: Major discrimination experiences
timeFrame: Baseline
measure: Longitudinal trajectory of daily discrimination experiences
timeFrame: Up to 40 weeks
measure: Longitudinal trajectory of employment status
timeFrame: Up to 40 weeks
measure: Longitudinal trajectory of housing/food security and financial stress
timeFrame: Up to 40 weeks
measure: Longitudinal trajectory of social support
timeFrame: Up to 40 weeks
measure: Early adversity
timeFrame: Baseline
measure: Life stress exposure
timeFrame: Baseline
measure: Longitudinal trajectory of perceived life stress
timeFrame: Up to 40 weeks
measure: Beliefs about mental health treatment and stigma
timeFrame: Baseline
measure: Insurance status
timeFrame: Baseline
measure: Willingness to pay
timeFrame: Baseline
measure: Perceived need
timeFrame: Baseline
measure: Longitudinal trajectory of sleep quality
timeFrame: Up to 40 weeks
measure: Longitudinal trajectory of substance use
timeFrame: Up to 40 weeks
measure: Other mental conditions
timeFrame: Baseline
measure: Other medical conditions
timeFrame: Baseline
measure: Emotion dysregulation
timeFrame: Baseline
measure: Verbal ability
timeFrame: Baseline
measure: Abstract reasoning
timeFrame: Baseline
measure: Cognitive response
timeFrame: Baseline
measure: Selective attention
timeFrame: Baseline
measure: Processing speed
timeFrame: Baseline
measure: Visuospatial information processing
timeFrame: Baseline
measure: Socioemotional information processing
timeFrame: Baseline
measure: Mental health treatment history
timeFrame: Baseline
measure: Mental health treatment preference
timeFrame: Baseline
measure: Longitudinal trajectory of regulatory strategy use
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: East Los Angeles College
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Michelle Craske, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Kate Taylor, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: