RCT for Latina Mental Health Using Web-Based Apps

December 18, 2025 updated by: MarySue Heilemann, PhD, RN, FAAN, University of California, Los Angeles

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Catalina transmedia web-based app
Access to Confronting My Emotions/ Enfrentando Mis Emociones (Catalina), an interactive web-based app containing 31 minutes of story based, character-driven videos, featuring evidence-informed Latina characters (Catalina and Veronica) in a relatable story about dealing with depression and anxiety. All features are available 24 hours/day in Spanish and English via a participant's unique link, including access to "Veronica's Blog" linked to the story, and links to resources such as infographics on depression and anxiety, hotlines and helplines, free evidence-based apps, online support groups, SAMHSA's MH service locator plus "Veronica's" recommendation of up to 3 Latinx-serving MH Tx clinics in LA & Orange Counties where participants can see a primary care physician for referral to MH therapy or pharmacotherapy. Monthly text/email messages will be sent for 9 months to prompt/remind Latinas they can use their unique link to re-watch videos and re-visit Veronica's blog.
Behavioral: Catalina
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.
Other Names:
  • Confronting My Emotions
  • Enfrentando Mis Emociones
Active Comparator: Links to informational videos
Access to the control web-based app that offers links to 31 minutes of publicly available informational videos specifically about depression and anxiety in Spanish and English (that are not story based and feature no fictionalized characters), available 24 hours/ day via participant's unique link on Chorus. It will provides direct links to 3 public websites: 1) Mental Health America, 2) Anxiety & Depression Association of America, 3) SAMHSA. All offer even more links to various MH resources, platforms, videos, and to SAMHSA's MH service locator by ZIP Code including to low cost sites for MH Tx.
Behavioral: Control 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Initiating Mental Health Treatment (MH Tx)
Time Frame: 9 months
MH 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.
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological openness
Time Frame: 9 months
Psychological 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.
9 months
Mental health help seeking attitude
Time Frame: 9 months
The 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.
9 months
Propensity to seek help
Time Frame: 9 months
Help 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.
9 months
Indifference to Stigma
Time Frame: 9 months
Indifference 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.
9 months
Stigma Concerns
Time Frame: 9 months
Stigma 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.
9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: 9 months
The 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.
9 months
Anxiety
Time Frame: 9 months
The 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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: MarySue V. Heilemann, PhD,RN,FAAN, UCLA School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-5962
  • R01MH137232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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