NCT06516536

Brief Summary

In recent years, there has been growing interest in the well-being and mental health of college students, driven by a significant increase in mental health problems within this population. Several mindfulness interventions, a technique to improve present moment awareness and emotional acceptance, have shown positive results in improving mental health and developing healthy lifestyle habits in this group. A recent systematic review with meta-analysis (González et al. 2023) indicates that not only the complete standardized 8-week Mindfulness-Based Stress Reduction (MBSR) program but also other Mindfulness-Based Interventions (MBI) are effective. Compared to MBSR, other MBIs require less time commitment, making them more accessible to a larger population and potentially improving program adherence. In this study, the researchers compare the results of two interventions, one with MBSR (both in-person and virtual) and another with a shorter MBI (in-person) in a sample of 100 university students. Using four different tools as pre- and post-test measures (Healthy Lifestyle Questionnaire \[CEVS-2\], Mental Health Continuous Form \[MHC-SF\], Perceived Stress Scale \[PSS\], and Mood Regulation Skills Questionnaire). emotions \[ERSQ\] \]), researchers aim to establish the potential degree of health improvement that different mindfulness interventions can have on the health of university students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 17, 2024

Last Update Submit

July 23, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Healthy Lifestyle Questionnaire [CEVS-2]

    The Healthy Lifestyles Questionnaire (CEVS-2) evaluates habits related to physical activity, nutrition, rest, stress management, social relationships and personal hygiene using a 5-point Likert scale. Higher scores indicate better practices in these aspects, while lower scores suggest areas where improvement could be made.

    Up to twelve weeks

  • Mental Health Questionnaire [MHC-SF]

    The Mental Health Questionnaire (MHC-SF) evaluates mental health in different dimensions using a 5-point Likert scale. Higher scores indicate better mental health status in areas such as emotional, social and psychological well-being, while lower scores may indicate areas of concern or need for support.

    Up to twelve weeks

  • The Perceived Stress Scale [PSS]

    Perceived Stress Scale (PSS). This scale is a self-report instrument that evaluates the level of perceived stress during the last month, it consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = occasionally when, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0=4, 1=3, 2=2, 3=1 and 4 =0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.

    Up to twelve weeks

  • Emotional Regulation Questionnaire [ERSQ])

    evaluates emotional regulation strategies using a 5-point Likert scale. Higher scores indicate a more effective and healthy use of strategies to manage and regulate emotions, while lower scores may indicate difficulties in this aspect.

    Up to twelve weeks

Study Arms (2)

Control Group (CG)

NO INTERVENTION

A control group (CG) that will not undergo treatment, which will be evaluated in the pre and post phase of the study.

Experimental Group

EXPERIMENTAL

In-person MBI: Intervention from Monday to Thursday, carried out in the first 20 minutes of class. Approach to mindfulness meditation, body scanning and simple yoga postures.

Other: MBI (Mindfulness-Based Intervention)

Interventions

Breath-Focused Meditation Approach (5-7 minutes): They will be guided to observe the flow of air in and out of the nose, noting sensations in the abdomen or chest. Body scan (7-8 minutes): Students will be guided through a careful exploration of their body. You'll start with your toes and slowly work your way toward your head, paying attention to the physical sensations in each part of your body. Simple yoga poses (5-7 minutes): Students will stand and follow instructions to perform a series of simple poses, such as mountain pose, tree pose, and cat-cow pose.

Experimental Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals enrolled in university education programs.
  • Specific age range that fits the typical characteristics of college students (e.g., 18-25 years old).
  • Participants who have given informed consent to participate in the study.
  • Students who can commit to participating in the intervention sessions and completing the evaluation questionnaires.

You may not qualify if:

  • Individuals with medical conditions that could interfere with safe participation in mindfulness sessions (e.g., serious cardiovascular conditions, respiratory disorders).
  • Students who have significant difficulties in language comprehension or communication that may affect participation and evaluation.
  • Students who are currently actively participating in other similar mindfulness programs could be excluded to avoid bias in the results.
  • Individuals with diagnoses of unstabilized serious mental disorders who may require more intensive clinical management.
  • Students who are unable to commit to scheduled dates and times for interventions and assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana María González Martín

Las Palmas de Gran Canaria, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 24, 2024

Study Start

February 26, 2024

Primary Completion

April 22, 2024

Study Completion

May 6, 2024

Last Updated

July 24, 2024

Record last verified: 2024-07

Locations