Clinical trial NCT06777407: Brief Mindfulness-Based Intervention to Reduce Psychological Distress in Health Sciences Students
Official title: Brief Mindfulness-Based Intervention to Reduce Psychological Distress in Health Sciences Students At a Public University in Peru
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mindfulness
Psychological Distress
Keywords: Health Sciences Students
Mindfulness
Psychological Distress
Lead sponsor: National University of San Marcos, Peru
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: This project aims to evaluate the effectiveness of a brief mindfulness-based intervention in reducing psychological distress among first-year health sciences students at the Universidad Nacional Mayor de San Marcos. The study will be a randomized controlled trial, comparing the effects of the intervention on psychological distress and mindfulness with standard treatment. Additionally, it will assess the acceptability of the virtual intervention, considering current limitations and the growing importance of digital tools.

Detailed description: General Objective To evaluate the effectiveness of a brief mindfulness-based intervention in reducing psychological distress in first-year health sciences students at UNMSM.

Hypothesis The average psychological distress score of first-year health sciences students at UNMSM who receive the mindfulness-based intervention will be lower compared to those who do not receive it.

The average mindfulness score of first-year health sciences students at UNMSM who receive the intervention will be higher compared to those who do not receive it.

Unit of Analysis First-year health sciences students from the Faculty of Medicine at UNMSM during the 2023 academic year.

Sampling The sampling will be non-probabilistic and convenience-based, including all students who wish to participate in the study.

Sample Size The sample size will consist of 60 participants per group, calculated using the formula for comparing two repeated means in two distinct groups.

Procedures

Participant Recruitment

Recruitment will take place during the month prior to the start of the intervention through invitations sent to institutional emails, the Faculty of Medicine's social media, text messages to students' cell phones (with prior authorization), and announcements in general classes. Participants will be enrolled during a one-week registration period, where they will complete an informed consent form and an initial assessment, which will include the following questionnaires:

Sociodemographic data sheet Perceived Stress Scale (PSS-13) Depression Symptoms Scale (PHQ-9) Mindfulness Scale (MAAS-5) Randomization

Participants will be randomly assigned to two groups using a random number generator:

Intervention Group (A): Will receive the brief mindfulness-based intervention, consisting of eight synchronous virtual sessions of 60 minutes once per week, along with a psychoeducational brochure.

Control Group (B): Will only receive the psychoeducational brochure and will be offered the intervention after the ninth week, once the study is completed.

Intervention

Content: The intervention is a mindfulness training program conducted in groups of 15 to 20 participants over eight weeks. The first session will be 90 minutes long, while the remaining sessions will last 60 minutes.

Program Implementation: A certified mindfulness trainer, not part of the research team, will guide the sessions. The program will be conducted over a two-month period with a total of 120 participants.

Evaluations Assessments will be conducted at the start of the intervention (M1) and at the end of the eight weeks (M2) using self-administered questionnaires. The primary outcome will be the scores on the Perceived Stress Scale, and secondary outcomes will include the Depression Scale, the Mindfulness Scale, and the Acceptability Scale (only in M2).

Analysis Plan

Primary Outcome: The treatment effect will be evaluated using a one-way ANOVA model, considering the variable defining the experimental and control group assignment as the treatment. Additionally, an analysis of covariance (ANCOVA) will be applied to account for the baseline outcome value as a covariate and adjust for potential residual confounding variables despite randomization. Effect sizes (η² and partial η²) will be calculated within the same model with 95% confidence intervals. Since a cluster effect may exist within the intervention subgroups, the intraclass correlation coefficient will be calculated to determine whether a multilevel model is necessary to adjust variance due to the cluster effect.

Secondary Outcome: A comparison of means between the experimental and control groups will be conducted.

Other Details: In the event of participant loss, results will be shown using an intention-to-treat analysis and compared with results analyzed according to protocol. All analyses will be conducted using R 4.2 (CRAN R Project).

Eligibility criteria: Inclusion Criteria:

Undergraduate health sciences students (from the schools of medicine, nursing, midwifery, nutrition, and medical technology) in their first year.

Students who have completed the initial pre-intervention assessment. Students who have signed the informed consent form. Students aged 18 years or older.

Exclusion Criteria:

Students with a score greater than 20 on the PHQ-9 scale (indicating severe depressive symptoms) at the time of the pre-intervention assessment.

Students with any other severe mental illness or a high risk of suicide.

Primary outcomes:
measure: Psychological Stress
timeFrame: At the beginning of the study
Secondary outcomes:
measure: Mindfulness
timeFrame: At the beginning of the study
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Faculty of Medicine, Universidad Nacional Mayor de San Marcos
Study officials:
References: