Anxiety Symptoms, Depressive Symptoms
Conditions
Keywords
digital intervention, depression, anxiety, app-based Intervention, university students, well-being, college students, mobile phone app
Brief summary
The goal of this clinical trial is to evaluate the efficacy of a mobile phone application for the early intervention of depression and anxiety among young university students in Chile. The main question it aims to answer is: \- Can a mobile app reduce depressive and anxious symptomatology in college students? Researchers will compare the intervention arm (mobile app users) to the control group (receives psychoeducational material and mental health care resources) to see if the app leads to significant improvements in depressive and anxious symptoms and well-being. Participants will: * Be randomly assigned to either the intervention or control group. * Use the mobile application, which includes psychoeducational materials, cognitive-behavioral therapy modules, and periodic personalized feedback. * Complete assessments at baseline, post-intervention, and 3 and 6 months after randomization using online tools such as the PHQ-9 for depressive symptoms and the GAD-7 for anxious symptoms.
Interventions
DEVICEVamosJuntxs App
Psychoeducational materials (videos, information and interactive exercises) about depression, anxiety and social support Skills training through information and activities based on the principles of cognitive behavioral therapy (cognitive restructuring, behavioral activation, emotional regulation, problem solving and exposure)
OTHERWeb Conciencia Saludable
mental health psychoeducational campaign (https://concienciasaludable.uchile.cl/)
Sponsors
University of Talca
Universidad de los Andes, Chile
Universidad Austral de Chile
Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* PHQ-9 and GAD-7 score between 5 and 14 points * Have a stable internet connection * To provide informed consent
Exclusion criteria
* High risk of suicide according to C-SSRS * Currently undergoing psychological, psychiatric and/or psychopharmacological treatment * Bipolar disorder, psychotic disorder or substance use disorder assessed with the respective modules of the MINI interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression symptoms | 6-weeks post-randomization | PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome |
| Anxiety symptoms | 6-weeks post-randomization | GAD-7, total score varies between 0 and 21, higher values represent a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Well-being | 6-weeks post-randomization | The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome |
| User Satisfaction | 6-weeks post-randomization | Ad-hoc satisfaction questionnaire for the intervention group, total score varies between 7 and 28, higher values represent a better outcome and an overall index with values ranging from 1 to 10 |
| Depression symptoms | 3-months post-randomization | PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome |
| Anxiety symptoms | 3-months post-randomization | GAD-7, total score varies between 0 and 21, higher values represent a worse outcome |
Countries
Chile
Outcome results
None listed