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OpenTrials
Active, Not Recruiting

NCT Number: NCT07109648

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University if Texas at Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Access to app

Behavioral

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

Primary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Social media use - TikTok

    Time frame: At 3 and 8 weeks after enrollment

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

Other outcomes

  1. Ongoing affect

    Time frame: Weekly from rectuiment up to 12 weeks.

    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

  2. Sleep quantity

    Time frame: At 3 and 8 weeks after enrollment

    hours slept the night before

  3. Sleep quality

    Time frame: At 3 and 8 weeks after enrollment

    The number of times participants experienced sleep interruptions the night before

  4. Social media use - Facebook

    Time frame: At 3 and 8 weeks after enrollment

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

  5. Psychotherapy

    Time frame: At 3 and 8 weeks after enrollment

    If the participant visit recently a therapist

  6. Effort

    Time frame: At 3 and 8 weeks after enrollment

    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

  7. Emotional interference

    Time frame: At 3 and 8 weeks after enrollment

    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

  8. Healthful habits

    Time frame: At 3 and 8 weeks of enrollment

    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.

  9. Isolation

    Time frame: At 3 and 8 weeks of enrollment

    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)

  10. Perceptions of efficacy

    Time frame: At 3 and 8 weeks after enrollment

    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).

  11. Social media use - X

    Time frame: At 3 and 8 weeks after enrollment

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

  12. Social media use - Instagram

    Time frame: At 3 and 8 weeks after enrollment

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

Sponsors and collaborators

Lead sponsor

Raissa Fabregas

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 7, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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