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Clinical Trials/NCT06628830
NCT06628830
Enrolling by Invitation
N/A

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

University of Chile1 site in 1 country200 target enrollmentMay 23, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depressive Symptoms
Sponsor
University of Chile
Enrollment
200
Locations
1
Primary Endpoint
Depression symptoms
Status
Enrolling by Invitation
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
May 23, 2024
End Date
August 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Depression symptoms

Time Frame: 6-weeks post-randomization

PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome

Anxiety symptoms

Time Frame: 6-weeks post-randomization

GAD-7, total score varies between 0 and 21, higher values represent a worse outcome

Secondary Outcomes

  • Well-being(6-months post-randomization)
  • User Satisfaction(6-weeks post-randomization)
  • Depression symptoms(6-months post-randomization)
  • Anxiety symptoms(6-months post-randomization)

Study Sites (1)

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