Actively Recruiting

Phase Not Applicable
Age: 18Years - 30Years
All Genders
Healthy Volunteers
ID06757842

Acceptability and Feasibility of an 8-week In-person Mindfulness-Based Cognitive Therapy Program in University Students Using a Quasi-experimental Design

Led by Universidad de los Andes, Chile · Updated on 2025-05-30

45

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Mental health issues such as depression, anxiety, and suicidal behaviors are increasingly common among university students worldwide. Studies have shown high rates of psychiatric disorders in this population, including in Chile where depressive symptoms and suicide risk remain significant concerns. This research aims to evaluate the feasibility and acceptability of an in-person mindfulness-based cognitive therapy program designed to reduce these mental health symptoms among undergraduate students at Universidad de los Andes. The intervention involves an 8-week Mindfulness Skills for Students program, delivered in-person by two trained facilitators at Universidad de los Andes. Each weekly session lasts 90 minutes and includes group mindfulness activities such as sitting meditation, body scan, and mindfulness of daily activities. Participants receive worksheets, access to an online platform with audiovisual guidance, and are asked to practice mindfulness exercises at home for 15 minutes daily. The program incorporates group discussions on stress management, mindfulness concepts, and acceptance of experiences. Participants will attend weekly sessions and complete daily home practice logs online. Researchers will assess the program's acceptability, recruitment feasibility, and participant satisfaction over about two years. Mental health outcomes like depression, anxiety, suicidal risk, quality of life, and mindfulness skills will be measured using standardized questionnaires throughout the study. The study will monitor any adverse events and provide support as needed, aiming to explore the program's impact on students' mental health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergraduate student at Universidad de los Andes
  • Aged between 18 and 30 years
  • Able to read and speak Spanish
  • PHQ-9 depression score between 0 and 14
  • Attended an informational meeting about the study and intervention
  • Available to attend one 90-minute session weekly for 8 consecutive weeks
  • Able to practice mindfulness exercises at home for at least 15 minutes daily during the intervention
Not Eligible

You will not qualify if you...

  • PHQ-9 depression score 15 or higher
  • Active suicidal ideation with a score of 3 or more on the Columbia suicide severity scale
  • Currently receiving psychiatric treatment for severe conditions such as psychotic disorders or substance abuse
  • Hospitalization for psychiatric conditions within the last 2 years
  • Previous participation in a mindfulness-based intervention course like MBCT, MBSR, or MMB
  • History of sexual abuse at any time in life

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants attend eight weekly 90-minute group mindfulness-based cognitive therapy sessions in person, co-facilitated by two instructors. They practice mindfulness exercises at home daily for about 15 minutes, supported by an online platform and home practice logs.

8 weekly visits (in-person)

Follow-up

Duration - Up to 2 years

Participants are monitored for acceptability, feasibility, and mental health outcomes including depression, anxiety, stress, and mindfulness skills for up to approximately 2 years after completing the intervention.

Periodic assessments during study completion

Trial Site Locations

Total: 1 location

1

Universidad de los Andes

Santiago, Santiago Metropolitan, Chile, 7620086

Actively Recruiting

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Research Team

J

Jorge E Gaete, MD, PhD

V

Valentina Romo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Published Research Related To This Trial

Prevalence and risk factors for mental health problems in university undergraduate students: A systematic review with meta-analysis.

Elena Sheldon, Melanie Simmonds-Buckley, Claire Bone...

https://pubmed.ncbi.nlm.nih.gov/33812241

WHO World Mental Health Surveys International College Student Project: Prevalence and distribution of mental disorders.

Randy P Auerbach, Philippe Mortier, Ronny Bruffaerts...

https://pubmed.ncbi.nlm.nih.gov/30211576

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study.

Marcelo Demarzo, Jesus Montero-Marin, Marta Puebla-Guedea...

https://pubmed.ncbi.nlm.nih.gov/28848465

Mindfulness interventions in medical education: A systematic review of their impact on medical student stress, depression, fatigue and burnout.

Zahra Daya, Jasmine Heath Hearn

https://pubmed.ncbi.nlm.nih.gov/29113526

How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies.

Jenny Gu, Clara Strauss, Rod Bond...

https://pubmed.ncbi.nlm.nih.gov/25689576

Effects of mindfulness exercises as stand-alone intervention on symptoms of anxiety and depression: Systematic review and meta-analysis.

Paul Blanck, Sarah Perleth, Thomas Heidenreich...

https://pubmed.ncbi.nlm.nih.gov/29291584

The effects of mindfulness-based cognitive therapy on recurrence of depressive episodes, mental health and quality of life: A randomized controlled study.

K A Godfrin, C van Heeringen

https://pubmed.ncbi.nlm.nih.gov/20462570