University StudentsNCT06516536
Mindfulness and Student Health
A study testing MBI (Mindfulness-Based Intervention) in people with University Students, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- University Students
- What is being tested?
- MBI (Mindfulness-Based Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2024to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions Based on Mindfulness and Their Influence on the Mental Health and Healthy Lifestyles of University Students.
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.
- Conditions
- University Students
- Being tested
- MBI (Mindfulness-Based Intervention)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBI (Mindfulness-Based Intervention)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MBI (Mindfulness-Based Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start26 Feb 2024
- Primary completion22 Apr 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516536
- Sponsor's protocol ID
- UJAEN.
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions Based on Mindfulness and Their Influence on the Mental Health and Healthy Lifestyles of University Students.
- ClinicalTrials.gov ID
- NCT06516536
- Acronym / sponsor ID
- UJAEN.
- Conditions
- University Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: MBI (Mindfulness-Based Intervention)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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBI (Mindfulness-Based Intervention)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. | Other | Experimental Group |
Primary outcome
Healthy Lifestyle Questionnaire [CEVS-2]
Time frame: Up to twelve weeks
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.
Mental Health Questionnaire [MHC-SF]
Time frame: Up to twelve weeks
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.
The Perceived Stress Scale [PSS]
Time frame: Up to twelve weeks
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.
Emotional Regulation Questionnaire [ERSQ])
Time frame: Up to twelve weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBI (Mindfulness-Based Intervention) in people with University Students, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Lifestyle Questionnaire [CEVS-2] (time frame: Up to twelve weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.