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

NCT ID: NCT06628830

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2025-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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:

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.

Group Type: EXPERIMENTAL

VamosJuntxs App

Intervention Type: 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)

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

Group Type: ACTIVE_COMPARATOR

Web Conciencia Saludable

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: DEVICE

Web Conciencia Saludable

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Talca

OTHER

Sponsor Role: collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role: collaborator

Universidad Austral de Chile

OTHER

Sponsor Role: collaborator

Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081

UNKNOWN

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 38414999 (View on PubMed)

Other Identifiers

Fondecyt 1221230

Identifier Type: -

Identifier Source: org_study_id