- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07910032
Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
A Randomized Controlled Trial of Group Psychological Intervention to Reduce Distress Among Nursing Undergraduates
This is a randomized controlled trial. The study aims to explore the effect of group psychological intervention on academic distress among nursing undergraduates whose score on the self-developed Nursing Undergraduate Academic Distress Scale is ≥29. Eligible students will be randomly assigned to the intervention group or the control group. The intervention group will receive an 8-week structured group psychological intervention, while the control group will receive routine mental health education. The primary outcome is the change in academic distress score from baseline to the end of the 8-week intervention. Feasibility of the intervention program will also be evaluated.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full-time undergraduate nursing students;
- Achieved a score ≥29 on the self-developed Nursing Undergraduate Academic Distress Scale;
- Aged 18 years or above;
- Voluntarily participate in this study and signed written informed consent;
- Able to attend all 8-week group sessions and complete baseline and post-intervention assessments.
Exclusion Criteria:
- Diagnosed with mental disorders or receiving ongoing psychiatric treatment / psychological counseling;
- Participating in other similar psychological intervention programs at the same time;
- Unable to persist in the whole 8-week intervention and follow-up assessment due to personal reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group psychological intervention
Participants will receive an 8-week structured group psychological intervention to alleviate psychological distress. |
8-week standardized group intervention program for alleviating psychological distress among nursing undergraduates. |
|
Active Comparator: Routine mental health education
Participants will receive routine general mental health education without the targeted distress intervention. |
General mental health science popularization education. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in psychological distress score
Time Frame: Baseline, immediately after the 8-week intervention, and 1-month follow-up
|
The change score of psychological distress scale from baseline to post-intervention, which is used to compare the difference of psychological distress level between intervention group and control group. |
Baseline, immediately after the 8-week intervention, and 1-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMU-2026-Trial-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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