NCT06757842 Acceptability and Feasibility of an In-person 8-week Mindfulness-Based Cognitive Therapy Program Among Undergraduates
| NCT ID | NCT06757842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de los Andes, Chile |
| Condition | Depression/Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2024-10-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mental health among university students has emerged as a significant global issue. Recent meta-analyses reveal that 25% of students experience depressive symptoms and 14% exhibit suicidal behaviors. A study involving 19 universities across 8 countries found that 31.4% reported psychiatric disorders in the past year, particularly major depressive episodes and anxiety disorders. In Chile, research on university mental health is limited. A 2014 study at Universidad Austral reported a 27% prevalence of depression and a 5.3% risk of moderate to severe suicide risk. The "First National Survey of University Mental Health" in 2019 revealed that 46% of students had depressive symptoms, while health surveys from Universidad de los Andes in 2020 and 2022 showed a decrease in these symptoms, although suicide risk remained high. Given this situation, preventive interventions are urgently needed. "Mindfulness-Based Interventions" (MBIs) have shown effectiveness in university settings. Mindfulness, defined by Jon Kabat-Zinn, involves deliberate, non-judgmental attention to the present moment. Programs like "Mindfulness-Based Stress Reduction" (MBSR) have proven effective in reducing symptoms of depression, anxiety, and stress. Studies indicate that MBIs can effectively alleviate mental health symptoms in university populations. Some of the MBIs include "Mindful Mood Balance" (MMB) and "Mindfulness Skills for Students". The latter has shown effectiveness in reducing depressive and anxious symptoms among university students. A 2021 pilot study at Universidad de los Andes on an online 8-session intervention combining mindfulness with cognitive-behavioral techniques yielded positive results in reducing symptoms and enhancing students' quality of life. In the current proposal we want to evaluate the feasibility and acceptability of the "Mindfulness Skills for Students" program delivered in-person by two trained facilitators. Additionally, we want to explore the efficacy of this intervention in reducing depressive, anxious, and stress symptoms among undergraduate students at Universidad de los Andes, using a quasi-experimental study design.
Eligibility Criteria
Inclusion Criteria: * Undergraduate students at the Universidad de los Andes. * Aged 18 or older. * Capable of reading and speaking Spanish. * With a score on the PHQ-9 depression scale between 0 and 14. * Have participated in an informational meeting about the study and the implications of the intervention. * Availability to attend 1 weekly session of 90 minutes for 8 consecutive weeks, and time to practice mindfulness exercises at home for at least 15 minutes daily during the intervention period. Exclusion Criteria: * With a PHQ-9 score greater than or equal to 15. * With active suicidality, defined as score ≥ 3 in Columbia suicide severity scale. * Currently undergoing psychiatric treatment for a severe condition, understood as: psychotic disorders and/or substance abuse. * History of hospitalization for psychiatric conditions in the last 2 years. * History of having participated in a previous MBI course, such as: MBCT, MBSR, MMB, among others. * History of sexual abuse in their lifetime.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06757842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 30 Years, studying Depression/Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06757842 currently recruiting?
Yes, NCT06757842 is actively recruiting participants. Contact the research team at jgaete@uandes.cl for enrollment information.
Where is the NCT06757842 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT06757842 clinical trial?
NCT06757842 is sponsored by Universidad de los Andes, Chile. The trial plans to enroll 45 participants.
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