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

NCT07109648 | Active Not Recruiting

• 2 other identifiers: STUDY00006401SA24-03-08
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Health; Wellbeing

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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)

  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)

  From enrollment to 3 and 8 weeks after

Secondary Outcomes (1)

• Social media use - TikTok

  At 3 and 8 weeks after enrollment

Other Outcomes (12)

• Ongoing affect

  Weekly from rectuiment up to 12 weeks.

• Sleep quantity

  At 3 and 8 weeks after enrollment

• Sleep quality

  At 3 and 8 weeks after enrollment

Study Arms (2)

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

Behavioral: Access to app

Interventions

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

Access to app

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Raissa Fabregas: lead

Study Sites (1)

The University if Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: April 18, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)