Clinical trial NCT06628830: Efficacy of a Mobile Phone App for Depression and Anxiety in College Students
Official title: Efficacy of a Mobile Phone Application for Early Intervention of Depression and Anxiety in Young College Students
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depressive Symptoms
Anxiety Symptoms
Keywords: digital intervention
depression
anxiety
app-based Intervention
university students
well-being
college students
mobile phone app
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: University of Talca
name: Universidad de los Andes, Chile
name: Universidad Austral de Chile
name: Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081
First posted: 2024-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Depression symptoms
timeFrame: 6-weeks post-randomization
measure: Anxiety symptoms
timeFrame: 6-weeks post-randomization
Secondary outcomes:
measure: Well-being
timeFrame: 6-weeks post-randomization
measure: User Satisfaction
timeFrame: 6-weeks post-randomization
measure: Depression symptoms
timeFrame: 3-months post-randomization
measure: Anxiety symptoms
timeFrame: 3-months post-randomization
measure: Well-being
timeFrame: 3-months post-randomization
measure: Depression symptoms
timeFrame: 6-months post-randomization
measure: Anxiety symptoms
timeFrame: 6-months post-randomization
measure: Well-being
timeFrame: 6-months post-randomization
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CEMERA, Faculty of Medicine, Universidad de Chile
state: Region Metropolitana
Study officials:
References:
citation: 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.