NCT06361394

Brief Summary

The aims of this study are to develop a mindfulness-based elective course for nursing students and to evaluate its effects on psychological well-being, including mindfulness, depression, anxiety, stress, and problematic internet use, empathy, among nursing students.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress66%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

February 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 18, 2026

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

February 15, 2024

Last Update Submit

March 16, 2026

Conditions

Keywords

EmpathyStressAnxietyNursing studentsMindfulnessProblematic internet use

Outcome Measures

Primary Outcomes (7)

  • Perceived Stress Scale score

    The Perceived Stress Scale is a validated self-report measure of perceived stress. Higher scores indicate greater perceived stress

    Baseline (T0) and end of course (T1, 18 weeks)

  • Generalized Anxiety Disorder 7-Item Scale score

    The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a validated self-report measure of anxiety severity. Higher scores indicate greater anxiety severity.

    Baseline (T0) and end of course (T1, 18 weeks)

  • Mindful Attention Awareness Scale score

    The Mindful Attention Awareness Scale is a validated self-report measure of mindfulness. Higher scores indicate greater mindfulness.

    Baseline (T0) and end of course (T1, 18 weeks)

  • Chinese version of the Jefferson Scale of Empathy score

    The Chinese version of the Jefferson Scale of Empathy is a validated self-report measure of empathy. Higher scores indicate greater empathy.

    Baseline (T0) and end of course (T1, 18 weeks)

  • The Problematic Internet Use Questionnaire-Short Form (PIUQ-SF) score

    The Problematic Internet Use Questionnaire-Short Form (PIUQ-SF) assesses problematic internet use, including obsession, neglect, and control disorder. Higher scores indicate more severe problematic internet use.

    Baseline (T0) and end of course (T1, 18 weeks)

  • Taiwan Five Facet Mindfulness Questionnaire score

    The Taiwan Five Facet Mindfulness Questionnaire (Taiwan FFMQ) assesses five facets of mindfulness. Higher scores indicate greater mindfulness.

    Baseline (T0) and end of course (T1, 18 weeks)

  • Depression, Anxiety, and Stress Scale-21 Score

    The Depression, Anxiety, and Stress Scale-21 (DASS-21) is a validated self-report measure of depression, anxiety, and stress. Higher scores indicate greater psychological distress.

    Baseline (T0) and end of course (T1, 18 weeks)

Study Arms (2)

Experimental: Mindfulness and Happiness elective course

EXPERIMENTAL

Participants in the experimental group will enroll in the elective course "Mindfulness and Happiness," which consists of 2 hours per week for 18 consecutive weeks.

Other: Mindfulness and Happiness elective course

No Intervention: Comparison group

NO INTERVENTION

Participants in the comparison group will not enroll in the elective course "Mindfulness and Happiness."

Interventions

Participants in the experimental group will receive the "Mindfulness and Happiness" elective course, consisting of 2 hours per week for 18 consecutive weeks.

Experimental: Mindfulness and Happiness elective course

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Nursing students enrolled at the participating university
  • Aged 18 years or older
  • Willing to participate in the study
  • Able to provide written informed consent
  • Enrolled in the elective course "Mindfulness and Happiness" for assignment to the experimental group, or not enrolled in the course for assignment to the comparison group

You may not qualify if:

  • Younger than 18 years
  • Unwilling or unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ya-Chu Hsiao

Taoyuan, N/A = Not Applicable, 333 03, Taiwan

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingAnxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The experimental group will enroll in the elective course named "Mindfulness and Happiness," which will consist of 2 hours every week for a continuous period of 18 weeks. The comparison group will not participate in this course.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 15, 2024

First Posted

April 11, 2024

Study Start

February 10, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 18, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

IRB does not allow

Locations