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| Name | Class |
|---|---|
| University of Talca | OTHER |
| Universidad de los Andes, Chile | OTHER |
| Universidad Austral de Chile | OTHER |
| Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay) NCS2021_081 |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression symptoms | PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome | 6-weeks post-randomization |
| Anxiety symptoms | GAD-7, total score varies between 0 and 21, higher values represent a worse outcome | 6-weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Well-being | The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), total score varies between 7 and 35, higher values represent a better outcome | 6-weeks post-randomization |
| User Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEMERA, Faculty of Medicine, Universidad de Chile | Santiago | Santiago Metropolitan | 8380455 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38414999 | Background | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| UNKNOWN |
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| Web Conciencia Saludable | Other | mental health psychoeducational campaign (https://concienciasaludable.uchile.cl/) |
|
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
| 6-weeks post-randomization |
| Depression symptoms | PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome | 3-months post-randomization |
| Anxiety symptoms | GAD-7, total score varies between 0 and 21, higher values represent a worse outcome | 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 | 3-months post-randomization |
| Depression symptoms | PHQ-9, total score varies between 0 and 27, higher values represent a worse outcome | 6-months post-randomization |
| Anxiety symptoms | GAD-7, total score varies between 0 and 21, higher values represent a worse outcome | 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 | 6-months post-randomization |