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

NCT06628830 | Enrolling By Invitation

• 1 other identifier: Fondecyt 1221230
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Anxiety Symptoms

Keywords

digital intervention; depression; anxiety; app-based Intervention; university students; well-being; college students; mobile phone app

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Well-being

  6-weeks post-randomization

• User Satisfaction

  6-weeks post-randomization

• Depression symptoms

  3-months post-randomization

• Anxiety symptoms

  3-months post-randomization

• Well-being

  3-months post-randomization

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention consists of an indicated prevention program delivered through a mobile app. The program will last 6 weeks and includes the following: 1. Psychoeducation on depression and anxiety 2. CBT skills training 3. 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 4. Chat with a psychologist (on demand) 5. 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

Control Group

ACTIVE COMPARATOR

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

Interventions

VamosJuntxs App DEVICE

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)

Intervention Group

Web Conciencia Saludable OTHER

mental health psychoeducational campaign (https://concienciasaludable.uchile.cl/)

Control Group

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PHQ-9 and GAD-7 score between 5 and 14 points
• Have a stable internet connection
• To provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, 8380455, Chile

Location

Related Publications (1)

• 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.

  PMID: 38414999 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: May 23, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)