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Enrolling by Invitation

NCT Number: NCT06628830

Efficacy of a Mobile Phone App for Depression and Anxiety in 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.

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Key information

Conditions

Depressive Symptoms Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEMERA, Faculty of Medicine, Universidad de Chile

Santiago, Santiago Metropolitan, 8380455, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Web Conciencia Saludable

Other

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

Primary outcomes

  1. Depression symptoms

    Time frame: 6-weeks post-randomization

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

  2. 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

  1. Well-being

    Time frame: 6-weeks post-randomization

    The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome

  2. User Satisfaction

    Time frame: 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

  3. Depression symptoms

    Time frame: 3-months post-randomization

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

  4. Anxiety symptoms

    Time frame: 3-months post-randomization

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

  5. Well-being

    Time frame: 3-months post-randomization

    The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome

  6. Depression symptoms

    Time frame: 6-months post-randomization

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

  7. Anxiety symptoms

    Time frame: 6-months post-randomization

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

  8. Well-being

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

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

Registry information

Official study title

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

Acronym: VamosJuntxs

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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