Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy

NCT05908565 | Recruiting DMC

• 1 other identifier: IRB#22-000218
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to optimize peer coaching in order to optimize engagement and outcomes in digital therapy. The unmet mental health needs of community college students are staggering and a growing body of research demonstrates that therapy provided digitally with the assistance of trained community members without advanced degrees in mental health is an effective and scalable way to address these needs. Despite being effective for improving symptoms and functioning in those who engage in it, uptake and engagement in digital therapy is generally quite low. Recent research suggests that this is especially true of Latinx individuals, who tend to have unique and significant unmet mental health needs. To address these issues, Project 2 will examine treatment engagement, treatment satisfaction, symptoms and functioning outcomes among Latinx students at East Los Angeles College (ELAC) receiving digital therapy with peer coaching in the STAND program.

Conditions

Depression; Anxiety

Keywords

personalized care; cognitive behavioral therapy; depression; anxiety

Outcome Measures

Primary Outcomes (1)

• Engagement

  Indexed by 1) proportion of digital therapy lessons completed and 2) proportion of coaching sessions attended.

  Up to 24 weeks

Secondary Outcomes (3)

• Treatment satisfaction

  Up to 24 weeks

• Symptom severity for mental health

  Up to 24 weeks

• Baseline social, occupational, and home functioning

  Baseline, Weeks 8, 16, and 24

Study Arms (3)

Aim 1

ACTIVE COMPARATOR

To examine the impact of demographic matching and supervision intensity on treatment engagement, treatment satisfaction, symptoms, and functioning for students receiving digital therapy. Hypothesis for Main Effect 1: Participants who are matched with Latinx peer coaches will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to participants who are not. Hypothesis for Main Effect 2: Participants assigned to peer coaches in standard supervision will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to those assigned to coaches in reduced supervision. Hypothesis for Interaction Effect: Students assigned to coaches who are demographically matched and receiving standard supervision will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to those in all other conditions.

Behavioral: Demographic Matching; Behavioral: Supervision Intensity

Aim 2

NO INTERVENTION

To examine explanatory/intervening variables impacting treatment engagement, treatment satisfaction, symptoms and functioning for students receiving digital therapy. Hypothesis 2: Evidence of mediation will be observed for the following five explanatory/intervening variables: 1) quality of the relationship between the participant and peer coach, 2) the participants' perception of cultural similarity with their coach, 3) the participants' treatment expectancy and treatment credibility, 4) the participants' perception of their peer coach's cultural competence, and 5) the peer coaches' fidelity to the treatment model.

Aim 3

NO INTERVENTION

To examine the cost-effectiveness of providing standard supervision. Hypothesis 3: Cost-effectiveness analyses will demonstrate that the increased costs incurred by standard supervision relative to reduced supervision will be justified by participants assigned to peer coaches receiving standard supervision experiencing greater improvements in symptoms than those assigned to peer coaches receiving reduced supervision.

Interventions

Demographic Matching BEHAVIORAL

At randomization, students will be randomized to a Latinx or non-Latinx coach and will be informed whether or not their coach identifies as Latinx. Although we are not recruiting coaches or matching coaches with participants based on gender, gender identity or lived experience with mental health problems, we will collect these data from coaches in order to do conduct secondary exploratory analyses examining these variables as predictors or moderators of outcome.

Aim 1

Supervision Intensity BEHAVIORAL

Coaches will be assigned to either standard supervision or reduced supervision, with equal distribution across Latinx vs non-Latinx. Coaches assigned to standard supervision will receive weekly supervision by a licensed provider consistent with the procedures outlined in the Data and Safety Monitoring Plan for the Signature Project. Coaches assigned to reduced supervision will attend weekly group supervision, but their session recordings or live sessions will not be reviewed by licensed supervisors or advanced peers and they will not receive personalized feedback about how they are performing in their sessions. Students will not be informed which supervision condition they have been assigned to in order to maintain high treatment expectancies. Of note, this design prohibits the coach and supervisors from being blind to participant condition.

Aim 1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Self-identify as Latinx.

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

East Los Angeles College

Los Angeles, California, 91754, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Amy Sewart, 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

916-202-5952; awelborn@mednet.ucla.edu

Tamar Kodish, Ph.D.

CONTACT

tamarkodish@ucla.edu

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: May 23, 2023
• First Posted: June 18, 2023
• Study Start: April 26, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

US (1)