NCT05591937

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. The total length of participation is 40 weeks.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable depression

Timeline
13mo left

Started Aug 2022

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Aug 2022Apr 2027

First Submitted

Initial submission to the registry

August 29, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

August 29, 2022

Last Update Submit

February 2, 2026

Conditions

Keywords

personalized carecognitive behavioral therapydepressionanxiety

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (30)

  • Demographic background

    Baseline

  • Language

    Baseline

  • Acculturative Stress

    Baseline

  • Major discrimination experiences

    Baseline

  • Longitudinal trajectory of daily discrimination experiences

    Up to 40 weeks

  • +25 more secondary outcomes

Study Arms (2)

Symptom Severity Decision-Making

ACTIVE COMPARATOR

Using current symptom severity level to guide triaging and adapting level of care.

Behavioral: Self-Guided Online PreventionBehavioral: Coach-Guided Online Cognitive Behavioral TherapyBehavioral: 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.

Behavioral: Self-Guided Online PreventionBehavioral: Coach-Guided Online Cognitive Behavioral TherapyBehavioral: Clinician-Delivered Psychological and Psychiatric Care

Interventions

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.

Data-Driven Decision-MakingSymptom Severity Decision-Making

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.

Data-Driven Decision-MakingSymptom Severity Decision-Making

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-MakingSymptom Severity Decision-Making

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Los Angeles College

Los Angeles, California, 91754, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Michelle Craske, Ph.D

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Kate Taylor, Ph.D

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelia Welborn, Ph.D.

CONTACT

Alainna Wen, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 29, 2022

First Posted

October 24, 2022

Study Start

August 29, 2022

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations