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

NCT ID: NCT07109648

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-18

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Health Wellbeing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Access to app

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

Group Type EXPERIMENTAL

Access to app

Intervention Type 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

Interventions

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Access 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University if Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SA24-03-08

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00006401

Identifier Type: -

Identifier Source: org_study_id

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