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Active, not recruitingNCT07109648Updated May 7, 2026

Evaluating the Impacts of a Well-Being Mobile App in Mexico

An interventional study of Access to app in Mental Health and Wellbeing, sponsored by Raissa Fabregas. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Raissa Fabregas · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Apr 2023, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
4,000
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Mental Health
  • Wellbeing
03

In context

Psychological Well-Being

971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 116 across 830 interventional studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

This is the only study on the registry with Raissa Fabregas as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • If she doesn't meet any of the inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,000 participants (estimated)

Study arms

  • No intervention
    Control

    Participants do not have access to the app during the study.

  • Experimental
    Access to app

    Participants will be offered free premium access to the app for three months

    Behavioral: Access to app

Interventions

  • BehavioralAccess to app

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to 3 and 8 weeks after

  2. 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)

    Time frame: From enrollment to 3 and 8 weeks after

  3. 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)

    Time frame: From enrollment to 3 and 8 weeks after

  4. 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)

    Time frame: 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

    Time frame: At 3 and 8 weeks after enrollment

Other outcomes

  1. Ongoing affect

    Measured through a purposely designed "emoji" survey, where the participants is asked how the participant is feeling. The options are very well, neutral, very bad. After it is constructed as a dummy variable that takes value of one if the participant answered "very well" or zero otherwise

    Time frame: Weekly from rectuiment up to 12 weeks.

  2. Sleep quantity

    hours slept the night before

    Time frame: At 3 and 8 weeks after enrollment

  3. Sleep quality

    The number of times participants experienced sleep interruptions the night before

    Time frame: At 3 and 8 weeks after enrollment

  4. Social media use - Facebook

    number of days in the last seven days the participant has used Facebook

    Time frame: At 3 and 8 weeks after enrollment

  5. Psychotherapy

    If the participant visit recently a therapist

    Time frame: At 3 and 8 weeks after enrollment

  6. Effort

    Performance on an incentive-compatible, real-effort task, where the participant needs to count the number of zeros in matrices of five columns and five rows where there are zeros and ones. The measure is the correct answers within one minute

    Time frame: At 3 and 8 weeks after enrollment

  7. Emotional interference

    reaction time in the emotional Stroop task, specifically for matching colors of emotionally salient words. The emotional Stroop task is a variation of the Stroop effect that explores how emotional stimuli impact cognitive processing. Participants are presented with words in different colors and asked to name the ink color while ignoring the word's meaning. Longer reaction times for emotional words (e.g., "fear," "sadness") compared to neutral words (e.g., "table," "chair") indicate interference from the emotional content

    Time frame: At 3 and 8 weeks after enrollment

  8. Healthful habits

    The index is calculated following Anderson (2008) and includes six standardized outcomes: the number of days in the last seven days the person exercised, went outside, did not miss work, did not raise her voice in anger, helped with homework, and had 10 minutes of self-time.

    Time frame: At 3 and 8 weeks of enrollment

  9. Isolation

    Emotional and social isolation, measured by the Gierveld Loneliness Scale. It has a range of scores from 0 (least lonely, better outcome) to 6 (most lonely, worse outcome)

    Time frame: At 3 and 8 weeks of enrollment

  10. Perceptions of efficacy

    measured using the Generalized Self-Efficacy Scale (GSE). The total score ranges between 10 and 40, with a higher score indicating more self-efficacy (better outcome).

    Time frame: At 3 and 8 weeks after enrollment

  11. Social media use - X

    number of days in the last seven days the participant has used X

    Time frame: At 3 and 8 weeks after enrollment

  12. Social media use - Instagram

    Number of days in the last seven days the participant used Instagram

    Time frame: At 3 and 8 weeks after enrollment

07

Study locations

1 site
  • The University if Texas at Austin
    Austin, Texas 78712, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07109648
Lead sponsor
Raissa Fabregas
Responsible party
Raissa Fabregas (Assistant Professor, University of Texas at Austin) — Sponsor-investigator
First posted
Aug 7, 2025
Start date
Apr 18, 2023
Primary completion
Aug 15, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
May 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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