About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Mindfulness in Students
BehavioralThe mindfulness intervention includes eight 90-minute group sessions held weekly at Universidad de los Andes, co-facilitated by two instructors. One leads the activities, while the other assists with technical aspects, monitors adverse events, and provides participant support. Participants will receive mindfulness worksheets and are required to practice at home for 15 minutes daily. They will have access to an online platform with audiovisual materials to guide their practice and will complete home practice logs online. Skills taught include sitting meditation (focused on breathing, thoughts, emotions, or sensations), body scan meditation, standing meditation, and mindfulness of daily activities. Group discussions will cover topics such as defining mindfulness, managing stress and pain, the difference between mindfulness and being on 'autopilot,' and how perceptions affect stress, as well as the relationship between pain and suffering, and the acceptance of unwanted experiences.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability Assessment
Acceptability will be evaluated by determining how this intervention program is received by students and the extent to which this intervention relates to the needs of this target population. The research team will develop an acceptability and satisfaction questionnaire and apply it to the intervention students
Feasibility Assessment: Number of participants recruited
Initially, inclusion and exclusion criteria will be defined to ensure that participants are representatives of the target group. A tracking system will be implemented to monitor the number of people recruited.
Feasibility Assessment: Recruitment time for completion
A tracking system will be implemented to monitor the time needed to complete the recruitment process.
Feasibility Assessment: Evaluation of data collection and results.
Clear protocols will be established for data collection and analysis, ensuring accuracy and consistency. Statistical analyzes will be used to check the validity and reliability of the results.
Secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
It is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which rates each of the 9 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria from "0" (Never) to "3" (Almost Every Day). In Chile, it has been validated among people aged 20 years and over, with a sensitivity of 92% and a specificity of 89%, compared to the Hamilton Depression Scale. In addition, it has construct validity and concurrent predictive validity with the The International Classification of Diseases, 10th Revision (CIE-10) criteria for depression. The interpretation is made by adding the total of the first nine questions: 0-4 points, without depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression.
Generalized Anxiety Disorder (GAD-7)
GAD-7 was originally designed primarily as a screening and severity measure for generalized anxiety disorder, this instrument also has good performance characteristics for other common anxiety disorders: panic disorder, social anxiety disorder, and post-traumatic stress disorder. This consists of 7 questions. The score is calculated by assigning scores from 0 to 3 to response categories from "Never" to "Almost Every Day." It has been validated in Spanish, where a cut-off score of 10 showed adequate values of sensitivity (86.8%) and specificity (93.4%). The scale was significantly correlated with Hamilton Anxiety scale (HAM-A) (0.852, p \< 0.001), and the Hospital Anxiety and Depression Scale (HADS ) (anxiety domain, 0.903, p \< 0.001). The GAD-7 total score for the seven items ranges from 0 to 21
Columbia-Suicide Severity Rating Scale (C-SSRS)
The first 5 items explore the presence of suicidal ideation, intention, and planning and are assessed over the past month. The sixth item explores suicidal behavior either as preparation, initiation of a suicide attempt, or a suicide attempt itself in the last three months. Each item is answered Yes or No. It has been validated in an English-speaking population (range of internal reliability goes from α=0.73 to α=0.93) and a Spanish-speaking population (α=0.53). The total score range is from 0 to 6 points. According to the answers provided To the different items, the categories of severity of suicidal ideation are established: If the answer is "Yes" to item 1 and/or item 2 and "No" to all the other items, a slight risk is indicated. If the answer is "Yes" to item 2 and answer "Yes" only to item 3, it suggests that the risk is moderate. If the answer si "Yes" to item 2 and the answer is "Yes" to any of items 4, 5, and 6, it indicates that the risk is severe.
Short Form-36 Health Survey (SF-36 v.2)
Instrument that assesses quality of life and general health status. It was developed by the Medical Outcome Study (MOS) and contains 36 items grouped into 8 health domains (Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health). The results of each dimension are coded and transformed into a scale ranging from 0 (the worst health status) to 100 (the best health status). Although the questionnaire is not designed to provide a global index, it allows for the calculation of two summary scores: Physical and Mental. This instrument has been validated in Chile.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.