Brief Mindfulness-Based Intervention to Reduce Psychological Distress in Health Sciences Students

NCT ID: NCT06777407

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-23
• Study Completion Date: 2025-06-30

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).

Conditions

Mindfulness; Psychological Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Information on self-care and managing psychological distress, along with 8 weeks of synchronous virtual sessions (1.5 hours per week), will be provided as part of the brief mindfulness-based intervention.

Group Type: EXPERIMENTAL

Brief Mindfulness-Based Intervention to Reduce Psychological Distress

Intervention Type: BEHAVIORAL

The brief mindfulness-based intervention is an eight-week training program designed for groups of 15 to 20 participants. The weekly sessions will last 90 minutes for the first session and 60 minutes for the following seven sessions. The program will be led by a certified mindfulness trainer, who is not part of the research team and will be solely responsible for training-related activities.

Control group

Information on self-care and managing psychological distress will be provided to help participants develop strategies for coping with mental health challenges effectively.

Group Type: OTHER

Psychoeducational brochure

Intervention Type: OTHER

Information on self-care and managing psychological distress will be provided. Once the study is completed and the data has been collected, participants in the control group will receive the intervention.

Interventions

Brief Mindfulness-Based Intervention to Reduce Psychological Distress

The brief mindfulness-based intervention is an eight-week training program designed for groups of 15 to 20 participants. The weekly sessions will last 90 minutes for the first session and 60 minutes for the following seven sessions. The program will be led by a certified mindfulness trainer, who is not part of the research team and will be solely responsible for training-related activities.

Intervention Type: BEHAVIORAL

Psychoeducational brochure

Information on self-care and managing psychological distress will be provided. Once the study is completed and the data has been collected, participants in the control group will receive the intervention.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of San Marcos, Peru

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Rojas Mezarina

Telehealth Unit Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Universidad Nacional Mayor de San Marcos

Lima, Lima Province, Peru

Countries

Peru

Other Identifiers

0222-2023

Identifier Type: -

Identifier Source: org_study_id