Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students (IMB)

Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students, Shanxi Province, China

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychological Stress; Nursing Students
• Intervention / Treatment: Behavioral: IMB stress self-management health education

Detailed Description

This study intends to select first-year undergraduate nursing students registered in October 2024 at Changzhi Medical College in Shanxi as the sampling population. A total of 120 eligible individual samples in eligible clusters will be screened according to inclusion and exclusion criteria, and the cluster samples will be randomly assigned to either the wait-list group or the intervention group. Participants in wait-list group will not receive any intervention, while participants in intervention group will receive IMB-based stress self-management health education. The intervention will last for 8 weeks, with one module delivers by weeks. Each module will include a 30-40 minute lecture combined with exercises, discussions, and role-playing activities. Measurements will be taken before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. These measurements will include the Stress Knowledge Questionnaire, the Multidimensional Scale of Perceived Social Support, the Self-Compassion Scale, the Resilience Scale, and the stress sub-scale of the Depression Anxiety Stress Scale.

The study data will be analyzed using the intention-to-treat (ITT) method. Continuous data will be described using mean (standard deviation) or median (interquartile range), and categorical data will be described using frequency and percentage. Repeated measures ANOVA will be used to compare differences between the two groups before the intervention, immediately after the intervention, and at 1 month, 3 months, and 6 months post-intervention. Generalized linear models (GMM) will be utilized to determine the effects of IMB-based stress self-management health education on the variables immediately post-intervention, and at 1 month, 3 months, and 6 months post-intervention, while controlling for confounding variables. Sensitivity analysis will be performed and reported. The mean estimates will be set with a 95% confidence interval, and the significance level will be set at P < 0.05.

This study aims to explore new low-cost approaches for current college student mental health education, improve stress self-management abilities and stress levels among nursing students, prevent mental disorders, and promote mental health. To ensure the safety of participants throughout the study, the research team will strictly adhere to ethical standards and undergo review and supervision by the ethics committee. Informed consent will be obtained from participants, and their privacy and personal information will be kept confidential, not disclosed or misused. Regular safety monitoring and risk assessments will be conducted. The research protocol will be strictly followed, and psychological counseling services will be provided to participants.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong Xiujuan, Master; Phone Number: +8618334526688; Email: 281046270@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. cluster

   • dormitories located in Changzhi Medical College
   • The residents in the dormitory are all nursing students that registered in fist-semester

2. 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

Exclusion Criteria:

1. 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.

2. individual

   • Diagnosed with mental problems or severe physical problems, e.g., depression, generalized anxiety disorder, or diabetes
   • Previous participation in other stress intervention studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: wait-list; participant in this group will not accept any psychological intervention content during experimental period. After the study, the intervention will be distributed for free.
Experimental: IMB stress self-management health education; 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; 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.; Other Names: "information-motivation-behavioral skills" stress self-management health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress Knowledge Questionnaire	Stress Knowledge Questionnaire (SKQ) is used to assess people's knowledge of stress. The questionnaire is consisting of 7 questions using true/false options as answer.	baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Stress Mindset Measure-General	Stress Mindset Measure- General is a self-reported instrument used to measure individual's belief toward stress. It is an 8-item tool to address the extent to which an individual adopts a mindset that the effects of stress are enhancing or debilitating. Each item rated in form of 5-Likert scale, ranging from 0=strongly disagree to 4=strongly agree. The item 1, 3, 5, 7 is negative items while the item 2, 4, 6, 8 is positive item. The total score is obtained by reverse scoring the four negative items and then taking the mean of all 8 items. Higher scores represent the mindset that stress is enhancing.	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	Multidimensional Scale of Perceived Social Support (MSPSS) is a self-report measure of social support scale that emphasizes individual subjective understanding and feelings. The questionnaire is a 12-item scale which designed to assess three perceived sources of supports: family (Items 3, 4, 8, and 11), friends (Items 6, 7, 9, and 12) and significant others (Items 1, 2, 5, and 10). Each item is scored from 1 (extremely disagree) to 7 (extremely agree). Three level of support can be categorized by the mean scale score. The mean scale score ranged from 1 to 2.9 could be considered low support; a score of 3 to 5 could be considered moderate support; a score from 5.1 to 7 could be considered high 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	The Chinese version of Self-Compassion Scale consists 12 items on five-point Likert scale (0= 'almost never' to 5= 'almost always') to record how often you behave kindly and caring toward yourself in difficult situations. It could be used to test three dimensions of self-compassion: Common Humanity, Mindfulness, and Self-Kindly. Item 2, 4, 5, 8, 11 are reverse scored item. The total score of the instrument ranged from 12 to 60, higher score indicates higher self-compassion, vice versa. The Chinese version SCS-SF exhibit high reliability and validity.	baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Connor-Davidson Resilience Scale	The 10-item psychological resilience scale is used to measure the ability to cope with illness, stress, failure, etc. The scale is a 5-point Likert (0= 'almost never' to 4= 'almost most') self-reported questionnaire; The total score of the scale is the sum of the response of each item, ranged from 0 to 40; Higher total score indicates higher resilience capacity.	baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.

Collaborators and Investigators

• Sponsor: Changzhi Medical College
• Investigators: Study Director: binti Ahmad Norliza, Dr, University Putra Malaysia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 10, 2024
• Primary Completion (Estimated): June 10, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Estimated): June 4, 2024

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: health education; IMB model; cluster-randomized controlled study
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: ChangzhiMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No