Guided mobile app intervention for depression and anxiety in university students
Effectiveness of a Guided Mobile App Intervention for Depression and Anxiety in University Students: a Multicenter Randomized Controlled Trial (PROMES-U Study)
This study is testing a mobile app called MyMoodCoach to see if it can help university students in Spain feel less depressed and anxious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of the Balearic Islands Academic / other |
| Locations | 1 site (Palma de Mallorca, Balearic Islands) |
| Trial ID | NCT06078007 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a guided mobile app intervention, MyMoodCoach, aimed at reducing depressive and anxiety symptoms among undergraduate students at six public universities in Spain. It is a multicenter randomized controlled trial where 600 students with mild to moderate symptoms will be randomly assigned to either the intervention group or a control group receiving treatment as usual. Participants will complete an online survey assessing various mental health factors, including sociodemographic variables and recent stressful events, to measure the intervention's impact on their mental health.
Who should consider this trial
Good fit: Ideal candidates for this study are undergraduate students aged 18 and older who exhibit mild to moderate symptoms of depression and/or anxiety and have access to a smartphone.
Not a fit: Patients with severe depression or anxiety, high suicide risk, or those currently receiving mental health treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide an accessible and effective tool for university students to manage and reduce symptoms of depression and anxiety.
How similar studies have performed: Previous studies have shown promise for minimally guided online interventions in reducing mental health symptoms, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible participants are all undergraduate students at the 6 participating universities and students followed in the PROMES-U observational study * Having 18 years of age or more * Having literacy in Spanish * Having access to a smartphone (Android or Apple) * With mild or moderate depression and/or anxiety symptoms screened (i.e., depression (5≤ (PHQ-9) ≤14); and/or anxiety (5≤ GAD-7 ≤14). Exclusion Criteria: * Moderately severe or severe depression and/or anxiety (i.e., PHQ-9≥15 and/or GAD-7≥15) * High suicide risk * A history of severe psychiatric disorder (e.g., bipolar, psychosis) * Being on mental health treatment (i.e., medication, psychotherapy or other intervention) Students with high suicide risk will receive a clinical alert recommending them to visit a specialist and a list of available mental health resources.
Where this trial is running
Palma de Mallorca, Balearic Islands
- Miquel Roca — Palma de Mallorca, Balearic Islands, Spain (Recruiting)
Study contacts
- Principal investigator: Jordi Alonso — Hospital de Mar Medical Research Institute (IMIM)
- Study coordinator: Jordi Alonso
- Email: jalonso@researchmar.net
- Phone: 93 316 07 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.