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

Not Applicable

• Conditions: Depressive Symptoms; Anxiety Symptoms

• Registration Number: NCT06628830
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-23
• Status Verified: 2024-09
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-08
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Well-being	6-months 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	6-months post-randomization	PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome
Anxiety symptoms	6-months post-randomization	GAD-7, total score varies between 0 and 21, higher values represent a worse outcome

Trial Locations

Locations (1)

CEMERA, Faculty of Medicine, Universidad de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile