Digital Therapy + Peer Coaching for Mental Health in Latinx College Students

(P2 Trial)

Overseen By Amelia Welborn, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Psychotic disorder, Severe eating disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 24 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance digital therapy for Latinx college students through peer coaching. It focuses on students at East Los Angeles College to determine if a coach with a shared background or increased supervision aids in maintaining engagement and improving mental health. The trial will also assess the costs of various coaching methods and identify factors that enhance coaching effectiveness. Ideal candidates are Latinx students at the college who are uninsured or on California Medicaid and have their own internet access. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health solutions tailored for Latinx students.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently being treated by a psychiatrist or psychologist, you must be willing to transfer your care to the STAND program during the trial.

What prior data suggests that digital therapy and peer coaching are safe for mental health treatment?

Research shows that digital therapy is generally safe for users. One study on internet-based cognitive behavioral therapy (CBT) found it reduced anxiety and depression in young adults without major side effects. This digital method allows users to access therapy at their own pace, often leading to better commitment and satisfaction.

Evidence suggests peer coaching is well-received and can improve mental health. Specifically, a study on brief peer coaching for young adult Latinas showed positive results, with participants experiencing better health habits and engagement. Peer coaching involves trained peers offering support, which many find relatable and comforting.

Overall, both digital therapy and peer coaching are safe and helpful, especially for mental health. However, individual experiences may differ, so consider personal comfort with these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores digital therapy paired with peer coaching tailored for Latinx college students, a group that often lacks culturally specific mental health support. Unlike traditional therapy methods, which might not always consider cultural nuances, this approach uses demographic matching to potentially enhance engagement and satisfaction. The trial also examines the impact of different levels of supervision for peer coaches, aiming to find a cost-effective way to boost mental health outcomes. By focusing on cultural similarity and peer support, this trial could pave the way for more personalized and effective mental health interventions.

What evidence suggests that this trial's treatments could be effective for mental health in Latinx college students?

Studies have shown that digital therapy can effectively improve mental health symptoms and functioning. For example, researchers have compared online cognitive behavioral therapy (i-CBT) to regular treatments and found it helpful. In this trial, participants will receive digital therapy, with some also receiving peer coaching. Research indicates that peer coaching can increase engagement in digital therapy, particularly among college students. One study found that peer support benefited nearly 60% of students who used it. These findings suggest that combining digital therapy with peer coaching could effectively address mental health needs in Latinx college students. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy Sewart, Ph.D.

Principal Investigator

University of California, Los Angeles

Kate Taylor, Ph.D.

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for Latinx students enrolled at East Los Angeles College who are either uninsured or have California Medicaid. Participants need private internet access to complete online programs and assessments.

Inclusion Criteria

Own or have private access to internet to complete the assessments and online prevention and therapy programs

Self-identify as Latinx.

I am either uninsured or covered by California Medicaid.

Exclusion Criteria

I can understand the consent form and answer questions about my health.

I am seeing a psychiatrist or psychologist and do not want to switch to STAND.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital therapy with peer coaching, randomized into different peer coaching conditions

24 weeks

Weekly assessments, longer assessments at baseline, weeks 8, 16, and 24

Follow-up

Participants are monitored for treatment engagement, satisfaction, and symptom severity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Therapy
• Peer Coaching

Trial Overview The study tests whether matching peer coaches by demographics and adjusting supervision intensity can improve engagement and outcomes in digital therapy for depression and anxiety among college students.

How Is the Trial Designed?

Group I: Aim 1 Active Control 2 Interventions

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.

Group II: Aim 3 Active Control 1 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.

Group III: Aim 2 Active Control 1 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.

Digital Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Digital Therapy for:

• Anxiety
• Depression
• Social Anxiety Disorder

Approved in European Union as Digital Mental Health Intervention for:

• Mental Health Support
• Anxiety Management
• Depression Treatment

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A study involving 2090 college students found that students of color reported higher levels of depression, anxiety, and suicidality but were less likely to have received prior mental health treatment compared to their non-Hispanic white peers.

Despite the disparities in prior treatment, students of color were equally likely to enroll in and start online or face-to-face therapy offered through the campus initiative, suggesting that online mental health resources can effectively reach underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Racial/Ethnic Equity in College Student Mental Health Through Innovative Screening and Treatment. Kodish, T., Lau, AS., Gong-Guy, E., et al.[2022]

In a study involving 308 postsecondary students undergoing internet-delivered cognitive behavioral therapy (ICBT), 54% completed the treatment, showing significant improvements in depression and anxiety symptoms that were sustained at 1 and 3 months post-treatment.

While motivational interviewing (MI) before treatment did not enhance completion rates, students who accessed self-guided booster lessons after treatment experienced greater reductions in depressive symptoms, suggesting that timing and support for boosters may be crucial for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Postsecondary Students: Randomized Factorial Trial for Examining Motivational Interviewing and Booster Lessons. Peynenburg, V., Hadjistavropoulos, H., Thiessen, D., et al.[2022]

Computerized cognitive-behavioral therapy (cCBT) for depression and anxiety showed significant symptom and functional improvements in university students, similar to results from controlled efficacy trials.

Despite the effectiveness of cCBT, the study found low rates of session completion among participants, and sending email reminders did not improve retention rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot implementation of computerized cognitive behavioral therapy in a university health setting. Santucci, LC., McHugh, RK., Elkins, RM., et al.[2018]

The demand for mental health care among college students has surged, prompting the exploration of peer-to-peer support programs as a viable solution to extend mental health services on campuses.

Programs like the College Mental Health Program at McLean Hospital and the Student Support Network at Worcester Polytechnic Institute demonstrate the potential effectiveness of student-to-student support, although more empirical research is needed to solidify their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-based initiatives in college mental health: students helping students to overcome obstacles. Kirsch, DJ., Pinder-Amaker, SL., Morse, C., et al.[2022]

The study involving 102 university students showed that internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of depression, anxiety, and stress over 8 weeks, with participants reporting the most improvement in the 'Space from Depression' and 'Space from Stress' programs.

Participants found the iCBT programs to be feasible and acceptable, appreciating the convenience and flexibility of the online format, which suggests that such interventions could effectively complement traditional face-to-face mental health services on campus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported Internet-Delivered Cognitive Behavioral Therapy Programs for Depression, Anxiety, and Stress in University Students: Open, Non-Randomised Trial of Acceptability, Effectiveness, and Satisfaction. Palacios, JE., Richards, D., Palmer, R., et al.[2020]

A study involving 1,224 U.S. undergraduate students found that interest in free mental health supports, such as teletherapy and online self-help, was very high at 70% and 72%, respectively, compared to only 20% and 25% for at-cost options.

Factors like age, anxiety severity, and race/ethnicity influenced students' interest in these digital mental health supports, highlighting the need for universities to tailor their mental health resources to better engage students during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

College student interest in teletherapy and self-guided mental health supports during the COVID-19 pandemic. Ahuvia, IL., Sung, JY., Dobias, ML., et al.[2022]

A digital mental health program providing internet-based cognitive behavioral therapy (iCBT) was successfully implemented in primary care, with 2,228 patients prescribed the program and nearly 49% enrolling, indicating good acceptance among patients.

Patients who engaged with the iCBT program showed significant clinical improvements, with a 23% reduction in depression scores (PHQ-9) and a 26% reduction in anxiety scores (GAD-7), demonstrating the efficacy of digital tools in treating mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing depression and behavioral health needs through a digital program at scale. Sharif-Sidi, Z., Shen, C., Wong, W., et al.[2021]

Culturally adapted digital mental health interventions (DMHIs) have shown a large and significant positive effect (g = 0.90) on mental health outcomes for racial and ethnic minorities, based on a systematic review of 32 studies involving 653 participants.

These interventions are generally accepted and feasible, but a high attrition rate of 42% suggests that while participants are satisfied, many do not complete all modules, highlighting the need for further research to enhance engagement and effectiveness, especially for Black and Indigenous populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally adapted digital mental health interventions for ethnic/racial minorities: A systematic review and meta-analysis. Ellis, DM., Draheim, AA., Anderson, PL.[2022]

The SPARX computerized cognitive behavioral therapy program is seen as a promising way to improve access to mental health treatment for rural youth in Australia, especially when it supports privacy and offers choices in how to access services.

Participants found the design features of SPARX, such as its narrative structure and personalization options, appealing, indicating that engaging design is crucial for acceptance, regardless of the program's New Zealand origins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Young People in Rural Australia on SPARX, a Fantasy World Developed for New Zealand Youth With Depression. Cheek, C., Bridgman, H., Fleming, T., et al.[2020]

A study involving 70 graduate-level student coaches trained to provide digital guided self-help for mental health issues reported a high satisfaction rate, with 95% of coaches feeling positive about their training and supervision experience.

The training program, which included live sessions, videos, and a detailed manual, effectively prepared coaches, boosting their confidence and skills for helping college students with depression, anxiety, and eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training, supervision, and experience of coaches offering digital guided self-help for mental health concerns. Fitzsimmons-Craft, EE., Rojas, E., Topooco, N., et al.[2023]

A meta-analysis of 17 randomized controlled trials found that virtual cognitive behavioral therapy (CBT) is as effective as traditional face-to-face CBT in reducing symptoms of depression, supporting the idea that both delivery methods can be used interchangeably.

The study suggests that depressed males may benefit more from virtual CBT, highlighting a need for future research to include more male participants and those from marginalized groups to ensure equitable mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual versus Face-to-Face Cognitive Behavioral Treatment of Depression: Meta-Analytic Test of a Noninferiority Hypothesis and Men's Mental Health Inequities. Charron, CM., Gorey, KM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138320/

Effectiveness-implementation hybrid trial of Spanish ... The long-term goal of this research is to aid in the implementation of digital mental health interventions that can be sustainably implemented in low-resourced ...

2. psycnet.apa.org psycnet.apa.org/record/2024-31634-003

Internet-delivered cognitive behavior therapy versus treatment ... This study compared transdiagnostic self-guided and guided internet-delivered cognitive behavioral therapy (i-CBT) with treatment as usual (TAU) for clinically ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11078571/

Internet-delivered cognitive behavior therapy versus ... Only about 6.7–11.4% of LMIC college students (including those in Colombia and Mexico) receive minimally adequate treatment, compared to roughly 23.1% of ...

4. mental.jmir.org mental.jmir.org/2018/4/e11467/citations

Supported Internet-Delivered Cognitive Behavioral Therapy ... Internet-Based Cognitive-Behavioral Therapy ... College students' perceptions of telemental health to address their mental health needs.

5. dheal.berkeley.edu dheal.berkeley.edu/publications/effectiveness-implementation-hybrid-trial-spanish-language-digital-cognitive-behavioral

Effectiveness-implementation hybrid trial of Spanish language ... We will conduct an effectiveness-implementation hybrid trial (Type 2) design comparing engagement and clinical outcomes in two modalities of dCBT delivery.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05746767?cond=Depression%2FAnxiety&intr=Digital%20Cognitive%20Behavioral%20Therapy&lat=37.7553498&lng=-122.4054036&locStr=ZSFG,%20Potrero%20Avenue,%20San%20Francisco,%20CA,%20USA&distance=50&rank=1

Supporting Peer Interactions to Expand Access to Digital ... SUPERA: Supporting Peer Interactions to Expand Access to Digital Cognitive Behavioral Therapy for Spanish-speaking Safety-Net Patients in Primary Care.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214782925000557

Internet-based cognitive behavioral therapy for anxiety and ... This study examines the efficacy of individually tailored ICBT intervention with on-demand support for reducing anxiety and depressive symptoms in young adults.

8. latinomentalhealth.ucsf.edu latinomentalhealth.ucsf.edu/research-projects

Research Projects | Latino Mental Health Research Program The SUPERA project investigates the implementation of an evidence-based, Spanish language, digital cognitive-behavioral therapy (dCBT) intervention (SilverCloud) ...

9. apa.org apa.org/practice/digital-therapeutics-mobile-health

Digital mental health technologies Digital therapeutics (DTx) use software programs to deliver evidence-based and clinically validated interventions to diagnose, treat, or prevent mental and ...