Psychological StressIMBNCT06440837
Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students
A study testing IMB stress self-management health education in people with Psychological Stress and Nursing Students, run by Changzhi Medical College.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Nursing Students
- What is being tested?
- IMB stress self-management health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Stress, Nursing Students
- Being tested
- IMB stress self-management health education
- Keywords
- health education, IMB model, cluster-randomized controlled study
- Medical subject headings
- Stress, Psychological, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB stress self-management health educationBehavioural
Also called "information-motivation-behavioral skills" 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: IMB stress self-management health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Jun 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Xiujuan, Changzhi Medical College
- Investigators
- binti Ahmad Norliza, Dr, Study director, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440837
- Sponsor's protocol ID
- ChangzhiMC
- Acronym
- IMB
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 7726811Connor 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.
PubMed 12964174Crum 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.
PubMed 23437923Zimet 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.
PubMed 2280326
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Stress Self-management Health Education Based on IMB Theory Among Nursing Students, Shanxi Province, China
- ClinicalTrials.gov ID
- NCT06440837
- Acronym / sponsor ID
- IMB / ChangzhiMC
- Conditions
- Psychological Stress, Nursing Students
- Keywords
- health education, IMB model, cluster-randomized controlled study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changzhi Medical CollegeUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Jun 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: IMB stress self-management health educationParticipants in this arm will receive an online "IMB stress self-management health education" program. The health education intervention program contains eight module topics. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- cluster
- individual
Key exclusion criteria (6 listed)
- cluster
- individual
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMB stress self-management health educationAlso: "information-motivation-behavioral skills" stress self-management health educationThe 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. | Behavioural | IMB stress self-management health education |
Primary outcome
stress sub-scale of DASS-21
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
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.
5 secondary outcomes
Stress Knowledge Questionnaire
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Stress Mindset Measure-General
Time frame: 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
Time frame: 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
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Connor-Davidson Resilience Scale
Time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Results publication: PubMed 7726811Lovibond 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.
- Results publication: PubMed 12964174Connor 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.
- Results publication: PubMed 23437923Crum 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.
- Results publication: PubMed 2280326Zimet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
binti Ahmad Norliza, Dr study director
Universiti Putra Malaysia
Questions about this trial
What is this clinical trial studying?
A study testing IMB stress self-management health education in people with Psychological Stress and Nursing Students, run by Changzhi Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Xiujuan, Master (+8618334526688, 281046270@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress sub-scale of DASS-21 (time frame: baseline, immediately after the intervention, 1 month after the intervention, 3 months after the intervention, 6 months after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440837, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.