Depressive SymptomsVamosJuntxsNCT06628830
Efficacy of a Mobile Phone App for Depression and Anxiety in College Students
A study testing VamosJuntxs App and Web Conciencia Saludable in people with Depressive Symptoms and Anxiety Symptoms, run by University of Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Depressive Symptoms, Anxiety Symptoms
- What is being tested?
- VamosJuntxs App and Web Conciencia Saludable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChile
- Study dates
- 23 May 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- PHQ-9 and GAD-7 score between 5 and 14 points
- Have a stable internet connection
- To provide informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site
CEMERA, Faculty of Medicine, Universidad de Chile
Santiago, Santiago Metropolitan, 8380455
About this study
Official title: Efficacy of a Mobile Phone Application for Early Intervention of Depression and Anxiety in Young 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?
Read more
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
- Being tested
- VamosJuntxs App, Web Conciencia Saludable
- Keywords
- digital intervention, depression, anxiety, app-based Intervention, university students, well-being, college students, mobile phone app
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VamosJuntxs AppDevice
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 SaludableOther
mental health psychoeducational campaign (https://concienciasaludable.uchile.cl/)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: VamosJuntxs App |
| Control Group | Active comparator | 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 Receives: Other: Web Conciencia Saludable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome
Measured: 6-weeks post-randomization
Anxiety symptoms
GAD-7, total score varies between 0 and 21, higher values represent a worse outcome
Measured: 6-weeks post-randomization
Secondary outcomes (8)
Well-being
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome
Measured: 6-weeks post-randomization
User Satisfaction
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
Measured: 6-weeks post-randomization
Depression symptoms
PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome
Measured: 3-months post-randomization
Anxiety symptoms
GAD-7, total score varies between 0 and 21, higher values represent a worse outcome
Measured: 3-months post-randomization
Well-being
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome
Measured: 3-months post-randomization
Depression symptoms
PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome
Measured: 6-months post-randomization
Anxiety symptoms
GAD-7, total score varies between 0 and 21, higher values represent a worse outcome
Measured: 6-months post-randomization
Well-being
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome
Measured: 6-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Talca, Universidad de los Andes, Chile, Universidad Austral de Chile, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628830
- Sponsor's protocol ID
- Fondecyt 1221230
- Acronym
- VamosJuntxs
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38414999
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mobile Phone Application for Early Intervention of Depression and Anxiety in Young College Students
- ClinicalTrials.gov ID
- NCT06628830
- Acronym / sponsor ID
- VamosJuntxs / Fondecyt 1221230
- Conditions
- Depressive Symptoms, Anxiety Symptoms
- Keywords
- digital intervention, depression, anxiety, app-based Intervention, university students, well-being, college students, mobile phone app
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- University of Talca, Universidad de los Andes, Chile, Universidad Austral de Chile, Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081
- Study start
- 23 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: VamosJuntxs AppThe 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. |
| Control Group | Active comparator | Other: Web Conciencia SaludableParticipants 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 |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- PHQ-9 and GAD-7 score between 5 and 14 points
- Have a stable internet connection
- To provide informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VamosJuntxs AppPsychoeducational 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) | Device | Intervention Group |
| Web Conciencia Saludablemental health psychoeducational campaign (https://concienciasaludable.uchile.cl/) | Other | Control Group |
Primary outcome
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
8 secondary outcomes
Well-being
Time frame: 6-weeks post-randomization
User Satisfaction
Time frame: 6-weeks post-randomization
Depression symptoms
Time frame: 3-months post-randomization
Anxiety symptoms
Time frame: 3-months post-randomization
Well-being
Time frame: 3-months post-randomization
Depression symptoms
Time frame: 6-months post-randomization
Anxiety symptoms
Time frame: 6-months post-randomization
Well-being
Time frame: 6-months post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 38414999Lira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VamosJuntxs App and Web Conciencia Saludable in people with Depressive Symptoms and Anxiety Symptoms, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: 6-weeks post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.