Mental Health, Wellbeing
Conditions
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.
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
Sponsors
Raissa Fabregas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
* If she doesn't meet any of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Social media use - TikTok | At 3 and 8 weeks after enrollment | Number of days in the last seven days the participant used TikTok |
Countries
United States
Outcome results
None listed