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

NCT06777407 | Active Not Recruiting

• 1 other identifier: 0222-2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Psychological Distress

Keywords

Health Sciences Students; Mindfulness; Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Psychological Stress

  Psychological stress is an adaptive emotional response to threatening situations that enables individuals to respond effectively according to the environment or context. However, when this response becomes disproportionate in intensity, quality, or frequency, it can lead to discomfort and avoidance behaviors, negatively impacting a person's performance. The Escala de Percepción Global al Estrés (EPGE - 13) is a stress level measurement scale with two dimensions (one positive and the other negative) that has been adapted from previous versions with a greater number of items to this shorter 13-item scale that has been validated in different languages and different settings. In our environment it has been recently validated in university students resulting in an estimated reliability in the scores generated of a Cronbach's alpha of 0.79 for the eustress factor and 0.77 for the distress factor.

  At the beginning of the study

Secondary Outcomes (1)

• Mindfulness

  At the beginning of the study

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Brief Mindfulness-Based Intervention to Reduce Psychological Distress

Control group

OTHER

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

Other: Psychoeducational brochure

Interventions

Brief Mindfulness-Based Intervention to Reduce Psychological Distress 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.

Intervention Group

Psychoeducational brochure 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of San Marcos, Peru: lead

Study Sites (1)

Faculty of Medicine, Universidad Nacional Mayor de San Marcos

Lima, Lima Province, Peru

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Telehealth Unit Coordinator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: January 15, 2025
• Study Start: November 23, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)