NCT06440837

Brief Summary

The aim of this cluster randomized controlled study is to test the effectiveness of IMB stress self-management health education on nursing students registered in first semester. The main question aims to answer are: Does IMB stress self-management health education program improving stress in nursing students? Researcher will compare wait-list group without any intervention to experimental group which received IMB stress self-management health education, to see if IMB stress self-management health education works to improving stress among nursing students. Participants will Attend IMB stress self-management health education program once a week for 8 weeks. In addition, complete questionnaires at pre-intervention, post-intervention, 1-month post-intervention, 3-months post-intervention, 6-months post-intervention.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Oct 2024

Typical duration for not_applicable

Status
not yet 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 Progress87%
Oct 2024Aug 2026

First Submitted

Initial submission to the registry

May 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 10, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

8 months

First QC Date

May 28, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

health educationIMB modelcluster-randomized controlled study

Outcome Measures

Primary Outcomes (1)

  • stress sub-scale of DASS-21

    The DASS-42 is a 42 item self-report scale is designed to measure the emotional states of depression, anxiety and stress. Each of the 42 questions in DASS is scored on a 4-point scale ranging from 0("Did not apply to me at all") to 3("Applied to me very much, or most of the time"). Scores for Stress is calculated by summing the scores for the 14 items: 1, 6, 8, 11, 12, 14, 18, 22, 27, 29, 32, 33, 35, 39. Total score of the stress subscale ranged from 0 to 42, the level of stress can be categorized five level based on total score actually measured: normal (score from 0 to 14), mild (score from 15 to 18), moderate (score from 19 to 25), Sever (score from 26 to 33), extreme sever (score from 34 above), therefore, higher score indicate higher level of stress.

    baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

Secondary Outcomes (5)

  • Stress Knowledge Questionnaire

    baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

  • Stress Mindset Measure-General

    baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

  • Multidimensional Scale of Perceived Social Support

    baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

  • Self-Compassion Scale Short Form

    baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

  • Connor-Davidson Resilience Scale

    baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

Study Arms (2)

wait-list

NO INTERVENTION

participant in this group will not accept any psychological intervention content during experimental period. After the study, the intervention will be distributed for free.

IMB stress self-management health education

EXPERIMENTAL

Participants in this arm will receive an online "IMB stress self-management health education" program. The health education intervention program contains eight module topics.

Behavioral: IMB stress self-management health education

Interventions

The health education intervention program contains eight module topics: stress-related knowledge, the thinking and mentality under stress, social support, take care of your suffering, manage your difficult emotions, acceptance, embrace a better life, ending. One topic or session is delivered by weeks, each session lasting 30-40 minutes.

Also known as: "information-motivation-behavioral skills" stress self-management health education
IMB stress self-management health education

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • cluster
  • dormitories located in Changzhi Medical College
  • The residents in the dormitory are all nursing students that registered in fist-semester
  • individual
  • Registered in undergraduate nursing program
  • Registered in the first-semester study
  • Have a mobile device that can access internet
  • Voluntarily participated in this study

You may not qualify if:

  • cluster
  • The residents in the dormitory are mixed with students from other majors except nursing.
  • The residents in the dormitory are mixed with nursing students from other grade.
  • individual
  • Diagnosed with mental problems or severe physical problems, e.g., depression, generalized anxiety disorder, or diabetes
  • Previous participation in other stress intervention studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

  • Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25.

  • Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

MeSH Terms

Conditions

Stress, PsychologicalHealth Education

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • binti Ahmad Norliza, Dr

    University Putra Malaysia

    STUDY DIRECTOR

Central Study Contacts

Dong Xiujuan, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
To ensure allocation concealment, an external party using a "third-party" allocation approach will be employed. This involves using a research assistant to maintain allocation concealment. The list of eligible dormitories will be sent to a second research assistant, who will then carry out the sequence generation described above. Neither the researchers nor other research personnel will be aware of the specific dormitory group assignments.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The random sequence generation will be implemented at the cluster level rather than the individual level to prevent sample contamination. Dormitories meeting the eligibility criteria will be coded and randomly assigned to either the intervention group or the control group. The random assignment will be executed using computer-generated software on a research randomization website, with a 1:1 allocation ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research leader

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 4, 2024

Study Start

October 10, 2024

Primary Completion

June 10, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share