Acceptability and Feasibility of an In-person 8-week Mindfulness-Based Cognitive Therapy Program Among Undergraduates

NCT06757842 | Recruiting

• 2 other identifiers: FDI UAN23102 - MindfulnessFDI UAN23102
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression/Anxiety

Keywords

Depression; Anxiety; Undergraduates; Mindfulness

Outcome Measures

Primary Outcomes (6)

• 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

  through study completion, an average of 2 year

• 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.

  through study completion, an average of 2 year

• Feasibility Assessment: Recruitment time for completion

  A tracking system will be implemented to monitor the time needed to complete the recruitment process.

  through study completion, an average of 2 year

• 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.

  through study completion, an average of 2 year

• Feasibility Assessment: Evaluation of the acceptability of the intervention

  Surveys will be used to collect opinions and perceptions of participants about the intervention and the methods used.

  through study completion, an average of 2 year

• Client Satisfaction Questionnaire (CSQ-8)

  It is an 8-item instrument validated in English and translated and validated into Spanish that measures general satisfaction with health services received in various populations. The answers are Likert-type with four options each. In addition, there is space to write down comments and suggestions. This instrument will be slightly adapted to questions oriented to the study context. The Customer Satisfaction Questionnaire has an internal consistency ranging between α=0.83 and α=0.93. Each item on the CSQ-8 is rated on a 4-point scale, generally ranging from 1 (low satisfaction) to 4 (high satisfaction). Therefore, the minimum possible score on the CSQ-8 is 8 (1 point on each of the 8 items), and the maximum score is 32 (4 points on each item). A higher score on the CSQ-8 indicates greater client satisfaction with the services received, which is considered a better outcome. In this context, a higher score is better, as it reflects a better customer perception of the service.

  through study completion, an average of 2 year

Secondary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  through study completion, an average of 2 year

• Generalized Anxiety Disorder (GAD-7)

  through study completion, an average of 2 year

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  through study completion, an average of 2 year

• Short Form-36 Health Survey (SF-36 v.2)

  through study completion, an average of 2 year

• Five Facet Mindfulness Questionnaire (FFMQ)

  through study completion, an average of 2 year

Study Arms (1)

Intervention group

EXPERIMENTAL

The mindfulness intervention consists of eight group mindfulness skills sessions, held weekly in person at Universidad de los Andes, each lasting 90 minutes. The sessions will be co-facilitated by 2 instructors. One will lead the session activities, and the second facilitator will provide technical assistance for the session, monitor adverse events, and offer support to participants who may need it.

Behavioral: Mindfulness in Students

Interventions

Mindfulness in Students BEHAVIORAL

The 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

Universidad de los Andes

Santiago, Santiago Metropolitan, 7620086, Chile

RECRUITING

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MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jorge E Gaete, MD, PhD

CONTACT

+56226181000; jgaete@uandes.cl

Valentina Romo

CONTACT

+56984038329; vromo@miuandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This is a quasi-experimental study without a control group, with pre- and post-intervention assessments. The intervention consists of an eight-week, in-person mindfulness training aimed at the university population

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 3, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study and until five years after the end of the study.
• Access Criteria: Any researchers who ask the principal investigator fot secondary analysis, data anonymized.

Locations

CL (1)