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RCT for Latina Mental Health Using Web-Based Apps

Randomized Controlled Trial of a Choice-driven, Interactive, Storytelling Web-based App to Investigate Mental Health Treatment Initiation Among Symptomatic Latinas

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06874790
Enrollment
700
Registered
2025-03-13
Start date
2025-07-09
Completion date
2028-11-30
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Mental Health, Well-Being, Psychological

Keywords

Latina, Women, Therapy

Brief summary

This study compares a choice-driven, interactive, evidence-informed storytelling web-based app intervention with links to resources and treatment (Tx) recommendations (made by a character via her blog) and Tx locator, to a web-based app with links to publicly available informational internet videos, MH resources, and a treatment locator for at least moderately anxious/depressed untreated English and Spanish speaking Latinas to determine if a story-based, character-driven approach is more effective for catalyzing mental health treatment initiation.

Interventions

BEHAVIORALCatalina

Catalina transmedia web-based app intervention with 10 story-based videos (including bonus story extender videos) totaling 31 minutes plus the blog of the character, Veronica, which has MH resource links including Veronica's recommendations of at least 3 local Latinx-serving clinics in LA and Orange County ZIP Codes that offer low-cost MH Tx.

BEHAVIORALControl webpage

Links to informational videos (totaling 31 minutes) on depression and anxiety, listing of the same 3 local Latinx-serving clinics in LA and Orange County ZIP codes that offer low-cost MH Tx, and links to nationally available websites that offer resources (including access to service locators).

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Individual-level randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Latina (women who are from or have family ties to Latin America) * Currently resides in LA or Orange County * Age 18 and older * Able to speak, read, and write in English or Spanish * Score 10 or higher on GAD-7 and/or PHQ-8 * Access to the internet via smartphone, tablet, or computer * Not currently receiving mental health therapy or pharmacotherapy * Has not accessed mental health services during the previous 6 months

Exclusion criteria

* Not Latina or Hispanic * Under age 18

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Initiating Mental Health Treatment (MH Tx)9 monthsMH Tx initiation, defined as completing a MH specialist visit (initial evaluation or therapy visit) or a primary care visit that results in a pharmacotherapy prescription as documented by EHR data at the site identified by the participant as where they initiated MH Tx.

Secondary

MeasureTime frameDescription
Psychological openness9 monthsPsychological openness (attitudes) subscale score of the Inventory of Attitudes towards Seeking Mental Health Services (IASMHS). The IASMHS is a 24 item scale and has three internally consistent factors: psychological openness, help-seeking propensity, and indifference to stigma. The subscales,range from 0 to 32. Higher scores indicate more positive attitude toward seeking mental health services.
Mental health help seeking attitude9 monthsThe Mental Health Seeking Attitudes Scale (MHSAS) contains 9 items which produce a single mean score, ranging 1-7. It measures respondents' overall evaluation (unfavorable vs. favorable) of their seeking help from a mental health professional if they found themselves to be dealing with a mental health concern. A higher score indicates a more favorable attitude toward seeking help.
Propensity to seek help9 monthsHelp seeking propensity subscale score of the Inventory of Attitudes towards Seeking Mental Health Services (IASMHS). The IASMHS is a 24 item scale and has three internally consistent factors: psychological openness, help-seeking propensity, and indifference to stigma. Subscales range from 0 to 32. Higher scores indicate a greater willingness to seek help.
Indifference to Stigma9 monthsIndifference to Stigma subscale score of the Inventory of Attitudes towards Seeking Mental Health Services (IASMHS). The IASMHS is a 24 item scale and has three internally consistent factors: psychological openness, help-seeking propensity, and indifference to stigma. The subscale contains 8 items related to how concerned an individual would feel if others knew they were seeking psychological help, with each item rated on a 5-point Likert scale from 0 (disagree) to 4 (agree); a higher score indicates a greater indifference to stigma; meaning the person is less concerned about others finding out about their mental health treatment.
Stigma Concerns9 monthsStigma Concerns about Care (SCC) is a 3-item questionnaire with responses on a 1-10 point scale, with higher scores indicating more concern about stigma.

Other

MeasureTime frameDescription
Depression9 monthsThe Patient Health Questionnaire 8 (PHQ-8) is an 8 item questionnaire for depression symptoms experienced during the preceding 2 weeks. Responses are scaled 0-3, total score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Anxiety9 monthsThe Generalized Anxiety Disorder-7 (GAD7) is a 7-item questionnaire to measure the severity of anxiety over the preceding 2 weeks. Responses range from 0 (not at all) to 3 (nearly every day), with total score range 0-21. Higher scores indicate more severe anxiety.

Countries

United States

Contacts

Primary ContactStudy Coordinator
mediahealthstudy@gmail.com310-210-4273

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026