Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000984493
Ethics application status
Approved
Date submitted
2/07/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Date results provided
5/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of a Mindfulness Program on Stress and Well-being in University Students in Colombia
Scientific title
Autonomic and Emotional Effects of a 13-Week Mindfulness-Based Intervention on Psychophysiological Stress Markers and Academic Performance in Colombian University Students: A Quasi-Experimental Study
Secondary ID [1] 314794 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 338038 0
Anxiety symptoms 338039 0
Depressive symptoms 338040 0
Loneliness 338041 0
Poor autonomic regulation 338042 0
Dysautonomia 338393 0
Condition category
Condition code
Mental Health 334340 334340 0 0
Anxiety
Mental Health 334341 334341 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention consisted of a structured 13-week mindfulness-based program designed to reduce academic stress and improve emotional and physiological well-being in university students.

Content and materials:
Sessions included guided mindfulness practices such as body scan, mindful breathing, and present-moment awareness of thoughts and emotions. Each session also included reflective group discussions and practical exercises for daily integration. For example, participants practiced mindful walking and mindful listening during sessions, and were encouraged to apply these techniques informally throughout the week. No printed or digital materials were provided, but experiential practice was emphasized.

Delivery mode and setting:
The program was delivered face-to-face in groups of approximately 10–15 participants, in a quiet, distraction-free room on the university campus. Sessions took place before academic classes.

Frequency and duration:
The intervention was conducted once per week for 13 consecutive weeks. Each session lasted 60 minutes.

Provider and expertise:
Sessions were facilitated by a licensed psychologist trained in mindfulness-based interventions and with experience delivering MBSR-style programs in group settings.

Personalisation/adaptation:
The intervention followed a standardized structure. While session content was not tailored to individual participants, group discussions allowed participants to reflect on personal experiences and apply mindfulness practices to their academic context.

Adherence/fidelity monitoring:
Attendance was recorded weekly. Although no formal fidelity checklist was used, the facilitator followed a pre-designed protocol to ensure consistent delivery across sessions.

Intervention arm:
Participants in the experimental group received the 13-week mindfulness-based intervention. As this was a non-randomised study, participants were allocated to the intervention or control group using a matched convenience sampling method in a 1:2 ratio, based on availability and interest in participating in the sessions. Matching was based on age to minimize group differences. Participants in the control group did not receive any intervention during the study period.
Intervention code [1] 331392 0
Behaviour
Intervention code [2] 331393 0
Lifestyle
Intervention code [3] 331394 0
Treatment: Other
Comparator / control treatment
No treatment. Participants in the control group did not receive any intervention during the 13-week study period. They continued with their usual academic routines and were assessed at the same time points as the experimental group (pre- and post-intervention). No mindfulness, psychological, or wellness activities were introduced to the control group during the study. They were informed about the nature of the study and had the option to participate in a mindfulness workshop after the data collection was completed.
Control group
Active

Outcomes
Primary outcome [1] 342027 0
Change in heart rate (HR)
Timepoint [1] 342027 0
Baseline (Week 0) and post-intervention (Week 13)
Primary outcome [2] 342028 0
Change in loneliness levels
Timepoint [2] 342028 0
Baseline (Week 0) and post-intervention (Week 13)
Primary outcome [3] 342029 0
Change in conscientiousness scores
Timepoint [3] 342029 0
Baseline (Week 0) and post-intervention (Week 13)
Secondary outcome [1] 449351 0
Change in anxiety symptoms
Timepoint [1] 449351 0
Baseline (Week 0) and post-intervention (Week 13)
Secondary outcome [2] 449352 0
Change in depressive symptoms
Timepoint [2] 449352 0
Baseline (Week 0) and post-intervention (Week 13)
Secondary outcome [3] 449353 0
Change in psychological flexibility
Timepoint [3] 449353 0
Baseline (Week 0) and post-intervention (Week 13)
Secondary outcome [4] 449354 0
Change in perceived stress
Timepoint [4] 449354 0
Baseline (Week 0) and post-intervention (Week 13)
Secondary outcome [5] 449355 0
Change in sleep quality
Timepoint [5] 449355 0
Baseline (Week 0) and post-intervention (Week 13)

Eligibility
Key inclusion criteria
Currently enrolled undergraduate university student in Colombia

Aged between 16 and 33 years

Willing to participate voluntarily and provide informed consent

Not currently under medical treatment or taking medication

Available to attend weekly mindfulness sessions for the duration of the intervention (13 weeks)

Completed both pre- and post-intervention assessments
Minimum age
16 Years
Maximum age
33 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed medical or psychiatric condition requiring ongoing treatment

Current use of medications that may affect physiological or psychological responses

Participation in other psychological or stress-related interventions during the study period

Incomplete data in pre- or post-intervention assessments

Failure to attend the majority of the mindfulness sessions (for the intervention group)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses were performed using Statistical Package for the Social Sciences (SPSS) software version 24.0 (SPSS Inc., Chicago, IL., USA). Descriptive statistics (mean and standard deviation) were calculated for each variable. The Kolmogorov-Smirnov test was used to evaluate the normality and homogeneity of the variables, finding that the data did not follow a normal distribution. To analyze the differences between the groups in the variables evaluated in the pretest and posttest, the Mann-Whitney U test for independent samples was used to compare the changes observed in the experimental group versus the control group, and to evaluate the differential effect of the intervention. In addition, intragroup differences were calculated to analyze the changes within each group over time, allowing us to evaluate the evolution of the variables before and after the intervention. The effect size of the intervention was estimated using Cohen's d (Gignac & Szodorai, 2016). classifying it as: insignificant effect ( greater than or equal to -0.15 and < 0.15), small (greater than or equal to 0.15 and < 0.40), medium (greater than or equal to 0.40 and < 0.75), large (greater than or equal to 0.75 and < 1.10), very large (greater than or equal to 1.10 and < 1.45) and extremely large (> 1.45). Finally, to perform a more robust analysis and evaluate the changes induced by the intervention, the differences (deltas) between the groups were analyzed. Deltas were calculated as the difference between post-intervention, and pre-intervention values for each participant. Subsequently, the Mann-Whitney U test was applied to determine whether these differences were significant between groups. The significance level was set at p less than or equal to 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2024
Date of last participant enrolment
Anticipated
Actual
7/02/2024
Date of last data collection
Anticipated
Actual
31/05/2024
Sample size
Target
93
Accrual to date
Final
93
Recruitment outside Australia
Country [1] 27169 0
Colombia
State/province [1] 27169 0
Atlantico

Funding & Sponsors
Funding source category [1] 319349 0
University
Name [1] 319349 0
Universidad de la Costa
Country [1] 319349 0
Colombia
Primary sponsor type
University
Name
Universidad de la Costa
Address
Country
Colombia
Secondary sponsor category [1] 321838 0
University
Name [1] 321838 0
Universidad Europea de Madrid
Address [1] 321838 0
Country [1] 321838 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317930 0
Comisión de Investigación de la Escuela de Doctorado e Investigación - Universidad Europea de Madrid
Ethics committee address [1] 317930 0
Ethics committee country [1] 317930 0
Spain
Date submitted for ethics approval [1] 317930 0
22/01/2024
Approval date [1] 317930 0
31/01/2024
Ethics approval number [1] 317930 0
2024-611

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142598 0
Prof Juan Camilo Benitez Agudelo
Address 142598 0
Universidad de la Costa, Calle 58 #55-66, Barranquilla, Atlántico, 080002, Colombia
Country 142598 0
Colombia
Phone 142598 0
+573002015639
Fax 142598 0
Email 142598 0
[email protected]
Contact person for public queries
Name 142599 0
Juan Camilo Benitez Agudelo
Address 142599 0
Universidad de la Costa, Calle 58 #55-66, Barranquilla, Atlántico, 080002, Colombia
Country 142599 0
Colombia
Phone 142599 0
+573002015639
Fax 142599 0
Email 142599 0
[email protected]
Contact person for scientific queries
Name 142600 0
Juan Camilo Benitez Agudelo
Address 142600 0
Universidad de la Costa, Calle 58 #55-66, Barranquilla, Atlántico, 080002, Colombia
Country 142600 0
Colombia
Phone 142600 0
+573002015639
Fax 142600 0
Email 142600 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: https://osf.io/8p2cw/?view_only=2cdd2f5903df4eb08e331104b79dcfc4

• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Aprobado comite de investigacion y etica CI 2024-611.pdf


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo Study summary submitted for internal project appro... [More Details] Protocol.pdf

Documents added automatically
No additional documents have been identified.