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A Mindfulness-Based Intervention to strengthen mental health and psychological resources in university students: a randomized controlled trial

Effects of a Mindfulness-Based Intervention on the mental health of Brazilian university students: randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4hnphgb
Enrollment
Unknown
Registered
2023-05-19
Start date
2023-06-19
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental disorders

Interventions

This is a two-arm, parallel, blinded (for evaluators) randomized controlled clinical trial. Approximately 160 distance undergraduate students from Cesumar University who want to participate and meet t
F02.463.551

Sponsors

Universidade Cesumar
Lead Sponsor
Universidade Cesumar
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Undergraduate students from Cesumar University; aged =18 years; who wish to participate in the study; who can participate in at least six of the eight sessions of the mindfulness program; and who provide informed consent

Exclusion criteria

Exclusion criteria: Students with severe symptoms of anxiety (GAD-7 equal to or greater than 15), depression (PHQ-9 equal to or greater than 15) and severe mental disorder (self-reported); those who report experience with mindfulness, other meditations or mind-body practices such as yoga in the previous 6 months

Design outcomes

Primary

MeasureTime frame
Evaluate the effect of the intervention on symptoms of generalized anxiety. It is expected to find a reduction of at least 0.5 in the anxiety score, as assessed by the Generalized Anxiety Disorder-7 (GAD-7) scale, applied before and after 8 weeks of the mindfulness-based intervention.;Evaluate the effect of the intervention on averages of positive mental health. It is expected to find an increase of at least 0.5 in the positive mental health score, as assessed by the Mental Health Continuum - Short Form (MHC-SF) scale, applied before and after 8 weeks of the mindfulness-based intervention.

Secondary

MeasureTime frame
Evaluate the effect of the intervention on the sense of coherence. It is expected to find an effect of 0.5 or greater on the sense of coherence averages, verified by the Sense of Coherence-13 (SOC-13) instrument, applied before and after 8 weeks of the mindfulness-based intervention.;Evaluate the effect of the intervention on psychological resilience. It is expected to find an effect of 0.5 or greater on the means of resilience, verified by the Connor-Davidson Resilience Scale-10 (CD-RISC-10), applied before and after 8 weeks of the mindfulness-based intervention.;Evaluate the effect of the intervention on mindfulness. It is expected to find an effect of 0.5 or greater on the means of mindfulness, verified using the Mindful Attention Awareness Scale (MAAS), applied before and after 8 weeks of the mindfulness-based intervention.;Evaluate the effect of the intervention on psychological stress. It is expected to find a reduction of at least 0.5 in the average scores of perceived stress, verified using the Perceived Stress Scale-10 (PSS-10), applied before and after 8 weeks of the mindfulness-based intervention.;Evaluate the effect of the intervention on symptoms of depression. It is expected to find a reduction of at least 0.5 in mean depression scores, verified using the Patient Health Questionnaire-9 (PHQ-9), applied before and after 8 weeks of the mindfulness-based intervention.

Countries

Brazil

Contacts

Public ContactFabiane Penachiotti

Universidade Cesumar

fpenachiotti@gmail.com+55(44)33092630

Outcome results

None listed

Source: REBEC (via WHO ICTRP)