MindfulnessNCT06777407
Brief Mindfulness-Based Intervention to Reduce Psychological Distress in Health Sciences Students
A study testing Brief Mindfulness-Based Intervention to Reduce Psychological Distress and Psychoeducational brochure in people with Mindfulness and Psychological Distress, run by National University of San Marcos, Peru at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Psychological Distress
- What is being tested?
- Brief Mindfulness-Based Intervention to Reduce Psychological Distress and Psychoeducational brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePeru
- Study dates
- 23 Nov 2024to Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Peru1 site
Faculty of Medicine, Universidad Nacional Mayor de San Marcos
Lima, Lima Province
About this study
Official title: Brief Mindfulness-Based Intervention to Reduce Psychological Distress in Health Sciences Students At a Public University in Peru
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.
Read the 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
- Being tested
- Brief Mindfulness-Based Intervention to Reduce Psychological Distress, Psychoeducational brochure
- Keywords
- Health Sciences Students, Mindfulness, Psychological Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Mindfulness-Based Intervention to Reduce Psychological DistressBehavioural
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.
Psychoeducational brochureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Psychoeducational brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the beginning of the study
Secondary outcomes (1)
Mindfulness
This innate ability has been shown to help individuals cope more effectively with stressful situations.
The Mindful Awareness Attention Scale 5 (MAAS-5) is a brief adaptation of the original scale that has been validated in our environment with accepted levels of validity and reliability (omega coefficient 0.85) to measure mindfulness in university students. It consists of 5 items rated with Likert scale scores from 1 "almost always" to 6 "almost never", with higher scores indicating greater presence of the quality. The scale is in the public domain and does not require permission by the authors for its use for research purposes.
Measured: At the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start23 Nov 2024
- Primary completionFeb 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of San Marcos, Peru
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonardo Rojas Mezarina, National University of San Marcos, Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777407
- Sponsor's protocol ID
- 0222-2023
- Status last verified
- Sep 2024
- First submitted
- 19 Oct 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mindfulness-Based Intervention to Reduce Psychological Distress in Health Sciences Students At a Public University in Peru
- ClinicalTrials.gov ID
- NCT06777407
- Acronym / sponsor ID
- 0222-2023
- Conditions
- Mindfulness, Psychological Distress
- Keywords
- Health Sciences Students, Mindfulness, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University of San Marcos, PeruUniversity, hospital or other
- Study start
- 23 Nov 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Brief Mindfulness-Based Intervention to Reduce Psychological DistressInformation 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. |
| Control group | Other | Other: Psychoeducational brochureInformation on self-care and managing psychological distress will be provided to help participants develop strategies for coping with mental health challenges effectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Brief Mindfulness-Based Intervention to Reduce Psychological DistressThe 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. | Behavioural | Intervention Group |
| Psychoeducational brochureInformation 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. | Other | Control group |
Primary outcome
Psychological Stress
Time frame: At the beginning of the study
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.
1 secondary outcome
Mindfulness
Time frame: At the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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 Brief Mindfulness-Based Intervention to Reduce Psychological Distress and Psychoeducational brochure in people with Mindfulness and Psychological Distress, run by National University of San Marcos, Peru at 1 site in Peru.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Jan 2025. 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 Peru. 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?
Results are not available in the source record.
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?
Psychological Stress (time frame: At the beginning of the study). 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 15 Jan 2025.