Mental HealthNCT06874790
RCT for Latina Mental Health Using Web-Based Apps
A study testing Catalina in people with Mental Health and Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Anxiety, Depression
- What is being tested?
- Catalina
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not Latina or Hispanic
- Under age 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
About this study
Official title: 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.
- Conditions
- Mental Health, Anxiety, Depression, Well-Being, Psychological
- Being tested
- Catalina, Control webpage
- Keywords
- Latina, Women, Therapy
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatalinaBehavioural
Also called Confronting My Emotions, Enfrentando Mis Emociones
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.
Control webpageBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Catalina transmedia web-based app | Experimental | 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. Receives: Behavioral: Catalina |
| Links to informational videos | Active comparator | 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. Receives: Behavioral: Control webpage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Initiating Mental Health Treatment (MH Tx)
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.
Measured: 9 months
Secondary outcomes (5)
Psychological openness
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.
Measured: 9 months
Mental health help seeking attitude
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.
Measured: 9 months
Propensity to seek help
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.
Measured: 9 months
Indifference to Stigma
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.
Measured: 9 months
Stigma Concerns
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start9 Jul 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual-level randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, MarySue Heilemann, PhD, RN, FAAN, University of California, Los Angeles
- Investigators
- MarySue V. Heilemann, PhD,RN,FAAN, Principal investigator, UCLA School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874790
- Sponsor's protocol ID
- 24-5962
- Other IDs
- R01MH137232
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Choice-driven, Interactive, Storytelling Web-based App to Investigate Mental Health Treatment Initiation Among Symptomatic Latinas
- ClinicalTrials.gov ID
- NCT06874790
- Acronym / sponsor ID
- 24-5962
- Conditions
- Mental Health, Anxiety, Depression, Well-Being, Psychological
- Keywords
- Latina, Women, Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individual-level randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Catalina transmedia web-based app | Experimental | Behavioral: CatalinaAccess 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. |
| Links to informational videos | Active comparator | Behavioral: Control webpageAccess 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Not Latina or Hispanic
- Under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CatalinaAlso: Confronting My Emotions, Enfrentando Mis EmocionesCatalina 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. | Behavioural | Catalina transmedia web-based app |
| Control webpageLinks 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). | Behavioural | Links to informational videos |
Primary outcome
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.
5 secondary outcomes
Psychological openness
Time frame: 9 months
Mental health help seeking attitude
Time frame: 9 months
Propensity to seek help
Time frame: 9 months
Indifference to Stigma
Time frame: 9 months
Stigma Concerns
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MarySue V. Heilemann, PhD,RN,FAAN principal investigator
UCLA School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catalina in people with Mental Health and Anxiety, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (310-210-4273, mediahealthstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Initiating Mental Health Treatment (MH Tx) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.