- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05413408
Intervention to Decrease the Stigma of Nursing Students
Chinese Culture-Specific Intervention to Decrease the Stigma of Nursing Students Towards Schizophrenia--A Pilot Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xi CHEN, MSN
- Phone Number: +85291203472
- Email: 20074345r@connect.polyu.hk
Study Locations
-
-
Hu Nan
-
Changsha, Hu Nan, China, 410000
- Recruiting
- Xiang Ya Hospital of Central South University
-
Contact:
- Yuting Zeng, Bachelor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants should be 18 years old or above.
- Participants should complete all the school courses to ensure that they have similar theoretical knowledge in psychiatric nursing.
- Participants can communicate in Mandarin.
- Participants are voluntarily participating in this study.
- Participants have not participated in any other similar intervention before.
- Participants are doing a clinical practicum in Xiangya Hospital, Changsha, Hunan Province.
Exclusion Criteria:
- Participants are receiving treatment of schizophrenia or other mental illness.
- Participants are lack of essential equipment to take an online interview.
- Regular personal contact with someone with schizophrenia or other mental illness (more than three times a month). Because people's prejudice may decrease when they meet and interact with people with mental illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: education and contact to change participants stigma towards schizophrenia
The intervention consists of three phases, including investigative learning activity (this section will last about one week), higher-order thinking activity (this section will last about two hours), collaborative activity (this section will last about two hours).
Both the intervention group and the control group will be interns in the hospital simultaneously.
The study outcomes include nursing students' knowledge, attitude, and behavioral intentions regarding stigma towards schizophrenia.
The intervention effect will be evaluated by the researcher, comparing results between and within the two groups from baseline (T0) to immediately after first and second session intervention (T1), immediately after third session intervention (T2), and three months follow-up (T3).
|
The intervention consists of three phases, including investigative learning activity (this section will last about one week), higher-order thinking activity (this section will last about two hours), collaborative activity (this section will last about two hours). Both the intervention group and the control group will be interns in the hospital simultaneously. The study outcomes include nursing students' knowledge, attitude, and behavioral intentions regarding stigma towards schizophrenia. The intervention effect will be evaluated by the researcher, comparing results between and within the two groups from baseline (T0) to immediately after first and second session intervention (T1), immediately after third session intervention (T2), and three months follow-up (T3). The control group only has one session and will be given a book of schizophrenia knowledge, and they will be asked to finish reading it in four weeks. |
|
Active Comparator: Participants reading a book about schizophrenia knowledge
The control group only has one session and will be given a book of schizophrenia knowledge, and they will be asked to finish reading it in four weeks.
|
The intervention consists of three phases, including investigative learning activity (this section will last about one week), higher-order thinking activity (this section will last about two hours), collaborative activity (this section will last about two hours). Both the intervention group and the control group will be interns in the hospital simultaneously. The study outcomes include nursing students' knowledge, attitude, and behavioral intentions regarding stigma towards schizophrenia. The intervention effect will be evaluated by the researcher, comparing results between and within the two groups from baseline (T0) to immediately after first and second session intervention (T1), immediately after third session intervention (T2), and three months follow-up (T3). The control group only has one session and will be given a book of schizophrenia knowledge, and they will be asked to finish reading it in four weeks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subject recruitment time
Time Frame: up to one month
|
The time used for subject recruitment
|
up to one month
|
|
Achievable recruitment rate
Time Frame: up to one month
|
the ratio between the number of nursing students actually participating and the number of potential nursing students that need to participat
|
up to one month
|
|
Eligibility rate of participants
Time Frame: up to one month
|
the number of participants eligible for this study/number of participants screened prior to eligibility assessment.
|
up to one month
|
|
The response rate of scales
Time Frame: up to three month
|
the proportions of missing values on the items of each scale
|
up to three month
|
|
Drop-out rate of participants
Time Frame: up to three month
|
the number of nursing students who drop out in each intervention session to the number of intervention groups
|
up to three month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of Schizophrenia as assessed by Knowledge about Schizophrenia Test (KAST)
Time Frame: up to three month
|
Knowledge about Schizophrenia Test (KAST)-Chinese version will be used to measure the stigma-related schizophrenia knowledge of participants.
KAST, including 18 items, demonstrate an acceptable reliability coefficient of 0.68.
The content validity index of items (I-CVI) ranged from 0.83 to 1.00, while the S-CVI/UA and S-CVI/Ave were 0.83 and 0.97, respectively, and known-group validity was satisfactory.
|
up to three month
|
|
Attitudes of Schizophrenia as assessed by Mental Illness Clinicians' Attitudes Scale (MICA)
Time Frame: up to three month
|
Mental Illness Clinicians' Attitudes Scale (MICA)- Chinese version will be used to measure stigma-related mental illness attitude of participants.
MICA is a six-point scale that includes 16 items, and response options are from 1=totally agree to 6=totally disagree.
The total score range is taken from 16-96.
The internal consistency 66 is 0.72-0.75, and test-retest reliability is 0.76-0.87 of MICA in the Chinese version.A lower score indicates participants having a positive attitude towards schizophrenia.
|
up to three month
|
|
Stigma behavior toward Schizophrenia as assessed by Reported and Intended Behavior Scale (RIBS)
Time Frame: up to three month
|
Reported and Intended Behavior Scale (RIBS)-Chinese version will be used to measure the stigma-related mental illness behavior of participants.
RIBS is a five-point scale that includes eight items, and response options are designed as 1=totally disagree, 2=disagree, 3=do not know, 4=agree, 5=totally agree.
The total score range is taken from 4-20 of items 5-8.
The internal consistency is 0.82, and test-retest reliability is 0.68 of RIBS in the Chinese version.The higher score indicates the participants are more willing to contact people who have schizophrenia.
|
up to three month
|
|
Empathy toward Schizophrenia as assessed by Jefferson Scale of Empathy-Health Profession Students (JSE-HPS)
Time Frame: up to three month
|
Jefferson Scale of Empathy-Health Profession Students (JSE-HPS)- Chinese version will be used to measure the nursing students' empathy towards people with schizophrenia.
S-JSE-HPS is a seven-point scale that includes twenty items, and response options are designed as 1=totally disagree to 7= totally agree.
The total score range is taken from 20-140.
The internal consistency is 0.93, and test-retest reliability is 0.92 of JSE-HPS in the Chinese version.The higher score indicates the participants have greater empathic attitudes toward schizophrenia.
|
up to three month
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Taşkın, E. O., Özmen, D., Özmen, E., & Demet, M. M. (2003). Attitudes of School of Health Students towards Schizophrenia. Archives of Neuropsychiatry, 40(1), 5-12.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- HSEARS20220127002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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