Mental HealthNCT07109648
Evaluating the Impacts of a Well-Being Mobile App in Mexico
A study testing Access to app in people with Mental Health and Wellbeing, run by Raissa Fabregas at 1 site in United States.
Trial summary
The researchers will study the impacts of offering access to an emotional well-being phone app to women in psychological distress in Mexico. The primary outcome is participants' psychological well-being and mental health. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Mental Health, Wellbeing
- What is being tested?
- Access to app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2023to 30 Aug 2026
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PHQ-4 scale equal or greater than 3
- Access to a smartphone and whatsapp
- Less than graduate school education
- Leaves in Mexico
- Earn less than 26,000 Mexican pesos
Who cannot join
- If she doesn't meet any of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
The University if Texas at Austin
Austin, Texas, 78712
About this study
The researchers will study the impacts of offering access to an emotional well-being phone app to women in psychological distress in Mexico. The primary outcome is participants' psychological well-being and mental health.
- Conditions
- Mental Health, Wellbeing
- Being tested
- Access to app
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to appBehavioural
The intervention is offering a free subscription to a mental health app that combines self-guided digital tools with AI-powered support. The app features functions such as an emotional diary and structured courses on topics including managing anxiety and stress regulation. A personalized chatbot, powered by large language models (LLMs) and trained on content grounded in cognitive behavioral therapy, delivers evidence-based strategies such as cognitive restructuring, behavioral activation, and emotion regulation. The chatbot also guides users through these resources using natural, supportive conversations.
Participants were randomly assigned to one of two groups:
A treatment group offered free access to the app for three months, or A control group, which will receive free access to the app for one month at the end of the study
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants do not have access to the app during the study. |
| Access to app | Experimental | Participants will be offered free premium access to the app for three months Receives: Behavioral: Access to app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellbeing
Measured using the World Health Organization-Five Well-Being Index (who-5). The raw score ranges from zero to 25, zero representing worst possible mental well-being and 25 representing best possible mental well-being.
Measured: From enrollment to 3 and 8 weeks after
Anxiety
Measured using General Anxiety Disorder-7 scale (GAD-7). This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. The definitions are:
0-4: minimal anxiety (better outcome) 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety (worse outcome)
Measured: From enrollment to 3 and 8 weeks after
Depression
Mesured using Personal Health Questionnaire Depression Scale (PHQ-8). This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." PHQ-8 total score for the eight items ranges from 0 to 24. The definitions are:
Less than 5: Minimal depression (better outcome) 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression More or equal to 20: Severe depression (worse outcome)
Measured: From enrollment to 3 and 8 weeks after
Stress
Measured using Perceived Stress Scale 4 (PSS-4). The scores range from 0 to 16 where higher scores are correlated to more stress (worse outcome)
Measured: From enrollment to 3 and 8 weeks after
Secondary outcomes (1)
Social media use - TikTok
Number of days in the last seven days the participant used TikTok
Measured: At 3 and 8 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start18 Apr 2023
- Primary completion15 Aug 2026 (estimated)
- Study completion30 Aug 2026 (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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raissa Fabregas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raissa Fabregas, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109648
- Sponsor's protocol ID
- STUDY00006401
- Other IDs
- SA24-03-08
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impacts of a Well-Being Mobile App in Mexico
- ClinicalTrials.gov ID
- NCT07109648
- Acronym / sponsor ID
- STUDY00006401
- Conditions
- Mental Health, Wellbeing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Raissa FabregasUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 7 Aug 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.
The researchers will study the impacts of offering access to an emotional well-being phone app to women in psychological distress in Mexico. The primary outcome is participants' psychological well-being and mental health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants do not have access to the app during the study. |
| Access to app | Experimental | Behavioral: Access to appParticipants will be offered free premium access to the app for three months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- PHQ-4 scale equal or greater than 3
- Access to a smartphone and whatsapp
- Less than graduate school education
- Leaves in Mexico
- Earn less than 26,000 Mexican pesos
Key exclusion criteria (1 listed)
- If she doesn't meet any of the inclusion criteria
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 |
|---|---|---|
| Access to appThe intervention is offering a free subscription to a mental health app that combines self-guided digital tools with AI-powered support. The app features functions such as an emotional diary and structured courses on topics including managing anxiety and stress regulation. A personalized chatbot, powered by large language models (LLMs) and trained on content grounded in cognitive behavioral therapy, delivers evidence-based strategies such as cognitive restructuring, behavioral activation, and emotion regulation. The chatbot also guides users through these resources using natural, supportive conversations. Participants were randomly assigned to one of two groups: A treatment group offered free access to the app for three months, or A control group, which will receive free access to the app for one month at the end of the study | Behavioural | Access to app |
Primary outcome
Wellbeing
Time frame: From enrollment to 3 and 8 weeks after
Measured using the World Health Organization-Five Well-Being Index (who-5). The raw score ranges from zero to 25, zero representing worst possible mental well-being and 25 representing best possible mental well-being.
Anxiety
Time frame: From enrollment to 3 and 8 weeks after
Measured using General Anxiety Disorder-7 scale (GAD-7). This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. The definitions are: 0-4: minimal anxiety (better outcome) 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety (worse outcome)
Depression
Time frame: From enrollment to 3 and 8 weeks after
Mesured using Personal Health Questionnaire Depression Scale (PHQ-8). This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." PHQ-8 total score for the eight items ranges from 0 to 24. The definitions are: Less than 5: Minimal depression (better outcome) 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression More or equal to 20: Severe depression (worse outcome)
Stress
Time frame: From enrollment to 3 and 8 weeks after
Measured using Perceived Stress Scale 4 (PSS-4). The scores range from 0 to 16 where higher scores are correlated to more stress (worse outcome)
1 secondary outcome
Social media use - TikTok
Time frame: At 3 and 8 weeks after enrollment
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 7 May 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to app in people with Mental Health and Wellbeing, run by Raissa Fabregas 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wellbeing (time frame: From enrollment to 3 and 8 weeks after). The study lists 4 primary outcomes in all. 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 7 May 2026.