Clinical trial NCT05908565: Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy
Official title: Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy
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: 2023-06-18
Enrollment: 240
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 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.

Detailed description: A sample of 240 students who identify as Latinx will be recruited. A 2x2 design will randomize students to 1 of 4 peer coaching conditions (n = 60 per condition): 1) demographic matching + standard supervision, 2) demographic matching + reduced supervision, 3) no demographic matching + standard supervision, and 4) no demographic matching + reduced supervision. Students in the demographic matching condition will be assigned to peer coaches who also identify as Latinx, whereas those in the no demographic matching condition will be assigned to peer coaches who do not identify as Latinx. Supervision will either involve individual session review and personalized feedback or not. Students will participate in this project for 24 weeks and will complete brief weekly assessment batteries and longer assessment batteries at baseline and at weeks 8, 16 and 24. Explanatory/intervening variables that are hypothesized to explain treatment effects will also be explored. In addition to the quantitative data collected from the randomized controlled trial, we will collect and analyze qualitative data from the peer coaches via annual focus groups and will evaluate cost-effectiveness specifically focused on costs related to supervision. These data will inform the iterative refinements made to Tier II in the Signature Project.

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
* Self-identify as Latinx.

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: Engagement
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: Up to 24 weeks
measure: Symptom severity for mental health
timeFrame: Up to 24 weeks
measure: Baseline social, occupational, and home functioning
timeFrame: Baseline, Weeks 8, 16, and 24
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: Amy Sewart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Kate Taylor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: