Clinical trial NCT06757842: Acceptability and Feasibility of an In-person 8-week Mindfulness-Based Cognitive Therapy Program Among Undergraduates
Official title: Acceptability and Feasibility of an 8-week In-person Mindfulness-Based Cognitive Therapy Program in a University Population: a Quasi-experimental Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression/Anxiety
Keywords: Depression
Anxiety
Undergraduates
Mindfulness
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed description: Mental health among university students has become a common and serious problem in higher education institutions worldwide in recent years. Over the past five years, various meta-analyses and systematic reviews have revealed concerning figures across the board. A recent meta-analysis found that the average prevalence of depression (from eight studies with 13,790 participants) was 25% (95% CI: 17%, 35%), and the combined prevalence of suicidal behaviors (from four studies with 2,586 participants) was 14% (95% CI: 0%, 44%). In another study that included 19 universities across eight countries (Australia, Belgium, Germany, Mexico, Northern Ireland, South Africa, Spain, and the U.S.) with responses from 13,984 students, it was found that the prevalence of any psychiatric disorder in the past 12 months was 31.4%. Among these disorders, the presence of a major depressive episode (18.5%), generalized anxiety disorder (16.7%), substance use disorder (3%), and alcohol use disorder (6.3%) were highlighted.

In Chile, there are very few studies addressing the prevalence of mental health disorders and associated risk factors in the university population. The article published in 2014 by Baader et al. is one of the first records we have in our country, conducted with a population of 800 students during 2008 at the Universidad Austral, reporting a prevalence of 27% for depression and 5.3% of students at moderate to severe risk of suicide. In April and May 2019, the results of the "First National Survey of University Mental Health" were presented, a project led by the Universidad Católica de Temuco and sponsored by the National Agency for Research and Development (ANID), conducted with 600 students from the Universidad Católica de Temuco, the Universidad de Concepción, and the Universidad de Tarapacá. This project showed that 46% of students exhibited depressive symptoms, 46% exhibited anxiety symptoms, and 53.5% exhibited stress symptoms. Furthermore, 29.7% presented all three symptoms simultaneously, and 5.1% of students had suicidal thoughts at the time of the study.

The data obtained from the Mental Health Surveys at the Universidad de los Andes, conducted in 2020 and 2022 among undergraduate students, indicate variations in the prevalence of different psychological symptoms and risks. Specifically, the prevalence of depressive symptoms decreased from 37.1% to 27.84%, while anxiety symptoms slightly reduced from 37.9% to 36.13%. Regarding stress, a notable decrease was observed, dropping from 54.6% to 12.9%. On the other hand, the prevalence of suicidal risk experienced a less pronounced decrease, from 20% to 18.4%, remaining at a considerably high index.

Given this situation, it is urgent to find preventive alternatives to address these issues. Among the interventions that have shown the most evidence in the last decade are "Mindfulness-Based Interventions" (MBI). This has prompted the incorporation of these interventions into the university setting. For example, by 2015, nearly 80% of the 140 accredited medical schools in the United States had incorporated some type of MBI into their curricula. Mindfulness refers to an intrinsic and modifiable capacity of the human mind, defined by Jon Kabat-Zinn as "the awareness (qualitative) that emerges when paying attention deliberately, in the present moment, and without judgment to experience moment to moment." Currently, there are various standardized therapeutic programs that teach skills based on mindfulness. The first one developed was the "Mindfulness-Based Stress Reduction" (MBSR), created by Jon Kabat-Zinn in the 1970s, who combined Buddhist meditation Dharma, psychological therapies, and advances in neuroscience, establishing the first milestone in the development of mindfulness as a health intervention, originally focused on alleviating symptoms in patients with chronic pain associated with systemic pathologies.

Subsequently, a group of behavioral therapists trained by Mark Williams, Zindel Segal, and John Teasdale created a program based on Jon Kabat-Zinn's model combined with cognitive-behavioral therapy, focused on preventing relapse in patients with major depressive disorder, called "Mindfulness-Based Cognitive Therapy (MBCT)." Both programs have a series of similarities and differences in their methodology. They are both based on mindfulness, but the fundamental difference is that MBCT focuses on identifying symptoms related to depression and anxiety, while MBSR focuses on identifying the effects of stress on the patient's life.

MBIs have been applied to various groups of patients with different health conditions and to healthy individuals, where studies have shown positive results in reducing depressive, stress, and anxiety symptoms, achieving mild to moderate benefits, both as monotherapy and as a complement to drug therapy. Within the university population, there are systematic reviews, meta-analyses, and clinical trials that show a correlation in the reduction of these symptoms. There have also been shortened interventions that have shown statistically significant benefits in students' symptoms.

Regarding the potential risks of MBIs, there is no high-quality evidence that definitively establishes the negative effects that mindfulness practice may entail for individuals. The most comprehensive study on this topic is a multicenter survey on the unexpected effects of meditation, conducted at various institutions between Spain and Brazil. Its results reflect that nearly 25% of participants reported experiencing some type of unexpected effect to varying degrees due to meditation practice, with between 1-4% reporting more severe effects. Among the most common complaints were the emergence or increased intensity of anxiety, pain, depression, and, to a much lesser extent, dissociative symptoms. However, none of these discomforts led practitioners to discontinue their meditation practice. Concerning expert opinions or case reports, it is relevant to highlight the precautions suggested by Zindel Segal, one of the creators of the MBCT program, which contraindicates the intervention in patients with acute psychiatric comorbidities, individuals with active suicidal ideation without treatment, and patients with untreated trauma.

Various adaptation protocols have been proposed, and one of the most notable is the one designed by Zindel Segal's group, one of the original authors of the MBCT program, called Mindful Mood Balance (MMB), which consists of a platform with audiovisual material (videos, audios, images, etc.) aimed at the self-application of the MBCT program. The effectiveness of this intervention has been studied in adult populations with anxious and depressive symptoms, demonstrating a significant decrease in PHQ-9 and General Anxiety Disorder-7 scores.

There is also a program crreated by Dr Elizabeth English and evaluated by Dr. Julieta Galante et al. in 2018, called "Mindfulness Skills for Students," applied in Cambridge, consisting of an abbreviated 8-week MBCT program. Unlike MMB, it includes guidance from mindfulness specialists to direct the practice and has the advantage of demonstrating positive results related to depressive and anxious symptoms in the university population. Thanks to a collaboration with Dr. Galante, we have been able to translate and adapt the "Mindfulness Skills for Students" program, which will be the basis for the intervention to be evaluated in this research project. In this regard, in 2021, a pilot study with a control group was conducted at the Universidad de los Andes (ClinicalTrials.gov Identifier: NCT05114824) that evaluated an online mindfulness-based intervention with cognitive-behavioral elements over 8 sessions among undergraduate students, showing a significant reduction in depressive and anxiety symptoms and an increase in quality of life among those who participated in the intervention compared to the control group. Another study in England evaluated a mindfulness intervention, which achieved notable reductions in perceived stress, anxiety, and depression compared to a control group, with sustained benefits during follow-ups at 3 and 6 months.

n 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.

Primary outcomes:
measure: Acceptability Assessment
timeFrame: through study completion, an average of 2 year
measure: Feasibility Assessment: Number of participants recruited
timeFrame: through study completion, an average of 2 year
measure: Feasibility Assessment: Recruitment time for completion
timeFrame: through study completion, an average of 2 year
measure: Feasibility Assessment: Evaluation of data collection and results.
timeFrame: through study completion, an average of 2 year
measure: Feasibility Assessment: Evaluation of the acceptability of the intervention
timeFrame: through study completion, an average of 2 year
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: through study completion, an average of 2 year
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: through study completion, an average of 2 year
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: through study completion, an average of 2 year
measure: Short Form-36 Health Survey (SF-36 v.2)
timeFrame: through study completion, an average of 2 year
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes
state: Metropolitana
Study officials:
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