Efficacy of a Mobile Phone App for Depression and Anxiety in College Students (VamosJuntxs)

Efficacy of a Mobile Phone Application for Early Intervention of Depression and Anxiety in Young College Students

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depressive Symptoms; Anxiety Symptoms
• Intervention / Treatment: Device: VamosJuntxs App; Other: Web Conciencia Saludable

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile, 8380455
      • CEMERA, Faculty of Medicine, Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The intervention consists of an indicated prevention program delivered through a mobile app. The program will last 6 weeks and includes the following: Psychoeducation on depression and anxiety; CBT skills training; mood and symptom monitoring and feedback: mood tracker and the application every two weeks of the PHQ-4 and question 9 of the PHQ-9; Chat with a psychologist (on demand); Optional modules on other related mental health topics (e.g. healthy habits, relaxation, mindfulness) Additionally, participants will be able to access additional help resources that include a speed dial button for a suicide prevention hotline and a web link to access contact information for mental health services. Finally, the intervention protocol also includes the eventual referral to face-to-face mental health care if required.	Device: VamosJuntxs 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)
Active Comparator: Control Group; Participants in the enhanced control group will receive a web link (https://concienciasaludable.uchile.cl/) with information about places to go to seek mental health care both inside and outside the respective university and psychoeducational material on depression and anxiety	Other: Web Conciencia Saludable; mental health psychoeducational campaign (https://concienciasaludable.uchile.cl/)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome	6-weeks post-randomization
Anxiety symptoms	GAD-7, total score varies between 0 and 21, higher values represent a worse outcome	6-weeks post-randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome	6-weeks post-randomization
User Satisfaction	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	6-weeks post-randomization
Depression symptoms	PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome	3-months post-randomization
Anxiety symptoms	GAD-7, total score varies between 0 and 21, higher values represent a worse outcome	3-months post-randomization
Well-being	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome	3-months post-randomization
Depression symptoms	PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome	6-months post-randomization
Anxiety symptoms	GAD-7, total score varies between 0 and 21, higher values represent a worse outcome	6-months post-randomization
Well-being	The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome	6-months post-randomization

Collaborators and Investigators

• Sponsor: University of Chile
• Collaborators: Universidad de los Andes, Chile; Universidad Austral de Chile; University of Talca; Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081

Publications and helpful links

General Publications

• Lira D, Caviedes P, Martinez V. Adaptation of a mobile app for early anxiety and depression intervention in university students in Chile: participatory study. BJPsych Int. 2023 May;20(2):37-41. doi: 10.1192/bji.2023.1.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: depression; anxiety; well-being; university students; digital intervention; college students; mobile phone app; app-based Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Anxiety Disorders; Depression
• Other Study ID Numbers: Fondecyt 1221230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No