Digital Therapy + Peer Coaching for Mental Health in Latinx College Students
(P2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Disqualifiers: Psychotic disorder, Severe eating disorder, others
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?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.
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 data supports the effectiveness of the treatment Digital Therapy + Peer Coaching for Mental Health in Latinx College Students?
Research shows that internet-based cognitive behavioral therapy (ICBT) can improve mental health care access and outcomes for students, and digital mental health tools can effectively reach underserved students of color. Additionally, virtual cognitive behavioral therapy has been found to be as effective as face-to-face therapy for depression.
12345Is digital therapy with peer coaching safe for mental health treatment in humans?
Research on digital therapy, like Internet-Based Cognitive Behavioral Therapy (ICBT), shows it is generally safe for treating mental health issues such as depression and anxiety in students, with improvements in symptoms reported. However, challenges like low completion rates and the need for cultural adaptations are noted, but no significant safety concerns have been identified.
12567How is Digital Therapy + Peer Coaching different from other mental health treatments for Latinx college students?
Digital Therapy + Peer Coaching is unique because it combines online cognitive behavioral therapy (a type of talk therapy) with support from trained peers, making it more accessible and relatable for Latinx college students who may face barriers to traditional mental health services. This approach leverages digital tools and peer support to bridge gaps in care and enhance engagement among underserved students.
2891011Eligibility Criteria
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.
+1 more
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
Trial Timeline
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
Participant Groups
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.
3Treatment groups
Active Control
Group I: Aim 1Active Control2 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 3Active Control1 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 2Active Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
East Los Angeles CollegeLos Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
References
Internet-Delivered Cognitive Behavioral Therapy for Postsecondary Students: Randomized Factorial Trial for Examining Motivational Interviewing and Booster Lessons. [2022]Internet-delivered cognitive behavioral therapy (ICBT) can improve access to mental health care for students, although high attrition rates are concerning and little is known about long-term outcomes. Motivational interviewing (MI) exercises and booster lessons can improve engagement and outcomes in face-to-face cognitive behavioral therapy.
Enhancing Racial/Ethnic Equity in College Student Mental Health Through Innovative Screening and Treatment. [2022]Although college campuses are diversifying rapidly, students of color remain an underserved and understudied group. Online screening and subsequent allocation to treatment represents a pathway to enhancing equity in college student mental health. The purpose of the current study was to evaluate racial/ethnic differences in mental health problems and treatment enrollment within the context of a largescale screening and treatment research initiative on a diverse college campus. The sample was comprised of n = 2090 college students who completed an online mental health screening survey and were offered either free online or face-to-face treatment based on symptom severity as a part of a research study. A series of ordinal, binomial and multinomial logistic regression models were specified to examine racial/ethnic differences in mental health problems, prior treatment receipt, and enrollment in online and face-to-face treatment through the campus-wide research initiative. Racial/ethnic differences in depression, anxiety and suicidality endorsed in the screening survey were identified. Students of color were less likely to have received prior mental health treatment compared to non-Hispanic white students, but were equally likely to enroll in and initiate online and face-to-face treatment offered through the current research initiative. Rates of enrollment in online therapy were comparable to prior studies. Online screening and treatment may be an effective avenue to reaching underserved students of color with mental health needs on college campuses. Digital mental health tools hold significant promise for bridging gaps in care, but efforts to improve uptake and engagement are needed.
Virtual versus Face-to-Face Cognitive Behavioral Treatment of Depression: Meta-Analytic Test of a Noninferiority Hypothesis and Men's Mental Health Inequities. [2022]Global rates of depression have increased significantly since the beginning of the COVID-19 pandemic. It is unclear how the recent shift of many mental health services to virtual platforms has impacted service users, especially for the male population which are significantly more likely to complete suicide than women. This paper presents the findings of a rapid meta-analytic research synthesis of 17 randomized controlled trials on the relative efficacy of virtual versus traditional face-to-face cognitive behavioral therapy (CBT) in mitigating symptoms of depression. Participants' aggregated depression scores were compared upon completion of the therapy (posttest) and longest follow-up measurement. The results supported the noninferiority hypothesis indicating that the two modes of CBT delivery are equally efficacious, but the results proved to be significantly heterogeneous indicating the presence of moderating effects. Indirect suggestive evidence was found to support moderation by gender; that is, depressed males may benefit more from virtual CBT. Perhaps, this field's most telling descriptive finding was that boys/men have been grossly underrepresented in its trials. Future trials ought to oversample those who have been at this field's margins to advance the next generation of knowledge, allowing us to best serve people of all genders, those who live in poverty, Indigenous, Black, and other Peoples of Colour, as well as any others at risk of being marginalized or oppressed in contemporary mental health care systems.
Addressing depression and behavioral health needs through a digital program at scale. [2021]Depression and anxiety disorders are prevalent mental health conditions; yet they are often unrecognized, under-addressed and/or under-treated, and specialty treatment for these conditions is oftentimes difficult to access. By acting either as a bridge to therapy or as a form of therapy, digital tools, such as those that provide internet-based cognitive behavioral therapy (iCBT), may help clinicians support their patients' mental health needs. At one academic health system, a digital mental health program was deployed in primary care and outpatient behavioral health programs to help patients meet needs identified through screening or clinical visits. Over the first two years of operation, 138 clinicians (40% of eligible clinicians) prescribed the program to 2,228 unique patients, from which 1,117 (48.9%) enrolled. Patients who enrolled tended to be younger and healthier than non-enrollees. On average, enrolled patients spent 114.6 minutes within the iCBT program. Clinical improvement was assessed using pre- and post PHQ-9 and GAD-7 scores for depression and anxiety, respectively. Pre/Post scores were compared using Wilcoxon Rank Sum test. Patients with at least moderate depression had an average 23% reduction in PHQ-9 scores (median change -3(interquartile range 7), p
Culturally adapted digital mental health interventions for ethnic/racial minorities: A systematic review and meta-analysis. [2022]Digital mental health interventions (DMHIs) are typically designed as "one-size fits all" which may perpetuate health disparities for racialized minorities. This systematic review identified culturally adapted DMHIs and examined their efficacy and acceptability among racial and ethnic minorities.
Pilot implementation of computerized cognitive behavioral therapy in a university health setting. [2018]This study evaluated the implementation of computerized cognitive-behavioral therapy (cCBT) for depression and anxiety in a university health center. Students reporting symptoms of depression and/or anxiety were offered cCBT and randomized to a session email reminder or no-reminder condition. Participants reported significant symptom and functional improvement after receiving treatment, comparable to outcomes achieved in controlled efficacy trials. However, rates of session completion were low, and reminders did not enhance retention. Results suggest that cCBT is a promising intervention in this population, with little attenuation of gains relative to efficacy trials but low levels of treatment completion.
Views of Young People in Rural Australia on SPARX, a Fantasy World Developed for New Zealand Youth With Depression. [2020]A randomized control trial demonstrated that a computerized cognitive behavioral therapy (cCBT) program (Smart, Positive, Active, Realistic, X-factor thoughts [SPARX]) was an appealing and efficacious treatment for depression for adolescents in New Zealand. Little is known about the acceptability of computerized therapy programs for rural Australians and the suitability of computerized programs developed in one cultural context when used in another country. Issues such as accents and local differences in health care access might mean adjustments to programs are required.
Population-based initiatives in college mental health: students helping students to overcome obstacles. [2022]College students' need for mental health care has increased dramatically, leaving campus counseling and mental health centers struggling to meet the demand. This has led to the investigation and development of extra-center, population-based interventions. Student-to-student support programs are but one example. Students themselves are a plentiful, often-untapped resource that extends the reach of mental health services on campus. Student-to-student programs capitalize on students' natural inclination to assist their peers. A brief review of the prevalence and effects of mental disorders in the college population is provided, followed by a broad overview of the range of peer-to-peer programs that can be available on college campuses. Two innovative programs are highlighted: (1) a hospital- and community-based program, the College Mental Health Program (CMHP) at McLean Hospital, and 2) the Student Support Network (SSN) at Worcester Polytechnic Institute. The subsequent section reviews the literature on peer-to-peer programs for students with serious and persistent mental illness for which there is a small but generally positive body of research. This lack of an empirical basis in college mental health leads the authors to argue for development of broad practice-research networks.
Supported Internet-Delivered Cognitive Behavioral Therapy Programs for Depression, Anxiety, and Stress in University Students: Open, Non-Randomised Trial of Acceptability, Effectiveness, and Satisfaction. [2020]Many university campuses have limited mental health services that cannot cope with the high demand. One alternative is to use internet-delivered cognitive behavioral therapy (iCBT) as a way of tackling barriers such as lack of availability and scheduling issues.
College student interest in teletherapy and self-guided mental health supports during the COVID-19 pandemic. [2022]Objective The COVID-19 pandemic has worsened college students' mental health while simultaneously creating new barriers to traditional in-person care. Teletherapy and online self-guided mental health supports are two potential avenues for addressing unmet mental health needs when face-to-face services are less accessible, but little is known about factors that shape interest in these supports. Participants: 1,224 U.S. undergraduate students (mean age = 20.7; 73% female; 40% White) participated. Methods: Students completed an online questionnaire assessing interest in teletherapy and self-guided supports. Predictors included age, sex, race/ethnicity, sexual minority status, and anxiety and depression symptomatology. Results: Interest rates were 20% and 25% for at-cost supports (teletherapy and online self-help, respectively) and 70% and 72% for free supports (teletherapy and online self-help, respectively). Patterns emerged by age, anxiety symptom severity, and race/ethnicity. Conclusions: Results may inform universities' efforts to optimize students' engagement with nontraditional, digital mental health supports, including teletherapy and self-guided programs.The SARS-CoV2 (COVID-19) pandemic has taken a severe toll on public health, with effects reaching far beyond unprecedented illness and mortality. Levels of mental health difficulties appear to be rising broadly as the pandemic has progressed, both in the general U.S. population and among college students specifically.1,2 The COVID-19 pandemic and its repercussions may undermine college student mental health in myriad ways.2 Concurrently, students now face the potential for serious illness, loss of loved ones, financial strain, social isolation, loss of on-campus resources, and sudden disruption of routines-creating a "perfect storm" for the emergence or exacerbation of psychological distress.
Training, supervision, and experience of coaches offering digital guided self-help for mental health concerns. [2023]Accessible, low-cost intervention options are necessary to address the rise in mental health problems among college students. Digital guided self-help, or coached, programs have been developed to provide such services, with many commercially available. As such, there are a large and growing number of individuals coaching these programs. However, an unmet need is to evaluate and assess best practices for training and supervising individuals in these positions. To this end, we describe how we recruited, trained, and supervised coaches as part of a large randomized controlled trial using a widely available digital commercial platform. Coaches were trained to provide digital guided self-help for depression, anxiety, and/or eating disorders for college students. Coaches initially attended three live training sessions over 2-3 weeks, viewed multiple training videos, and read a detailed coaching manual developed by our team. Thereafter, they attended weekly supervision. Following their term, coaches completed an exit survey to assess their supervision and training experiences. A total of 37 of 70 (53%) graduate-level student coaches completed the survey. The experience was reported as very positive (95%). In particular, the majority reported feeling well prepared, more confident, and felt they had developed useful skills for their own practice.