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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05413408
Other study ID # HSEARS20220127002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date July 1, 2023

Study information

Verified date March 2022
Source The Hong Kong Polytechnic University
Contact Xi CHEN, MSN
Phone +85291203472
Email 20074345r@connect.polyu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

not


Description:

Introduction Mental illness stigma is influenced by empathy, culture, and beliefs. However, few researchers specifically consider empathy, culture, and beliefs when designing interventions to reduce stigma. Schizophrenia is the most stigmatized mental illnesses. Nursing students will play the role of health educators and provide care for patients in the future. Their stigmas will negatively impact the care quality provided to people diagnosed with schizophrenia if not properly attended. This study intends to examine the feasibility, acceptability, and preliminary efficacy of an education and contact intervention programme aiming to improve nursing students' knowledge and empathy of schizophrenia and decrease their negative attitudes and stigma behavior towards people with schizophrenia. Methods and Analysis This is a two-phase study design. Phase 1 development includes a literature review and a descriptive qualitative study. Phase 2 is a pilot study, the feasibility, accessibility, and efficacy of the pilot RCT will be assessed by the quantitative and qualitative study. In the first phase, descriptive qualitative study with focus group and a literature review will be used to inform the intervention development of a pilot RCT. The second phase includes a pilot RCT including 60 nursing students who 7 practice in clinical settings of a tertiary hospital. These nursing students will be randomly assigned into the intervention group and the control group. The pilot study intervention consists of three stages, including the investigative learning activity (lasting about 6 hours), the collaborative activity (lasting about 4 hours), and the higher-order thinking activity (lasting about 4 hours). Both the intervention group and the control group will be interns in the tertiary hospital simultaneously when they take part in this study. The control group go through only one stage--they will be given a book about schizophrenia knowledge and asked to finish reading it in four weeks. After the pilot intervention study, there will be a process evaluation of a qualitative interview. Both first and second phase qualitative study will use qualitative research of fourth-year nursing students being focus groups interviewed. The pilot intervention study outcomes include nursing students' knowledge, attitude, and behavioral intentions regarding stigma towards schizophrenia, and nursing students' empathy towards people with schizophrenia. The pilot intervention study effect will be evaluated by the researcher and the results of the two groups will be compared on the baseline (T0), post-intervention (T1), and three months follow-up (T2).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 1, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Education and contact
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.

Locations

Country Name City State
China Xiang Ya Hospital of Central South University Changsha Hu Nan

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

References & Publications (50)

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* Note: There are 50 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Subject recruitment time The time used for subject recruitment up to one month
Primary Achievable recruitment rate 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
Primary Eligibility rate of participants the number of participants eligible for this study/number of participants screened prior to eligibility assessment. up to one month
Primary The response rate of scales the proportions of missing values on the items of each scale up to three month
Primary Drop-out rate of participants the number of nursing students who drop out in each intervention session to the number of intervention groups up to three month
Secondary Knowledge of Schizophrenia as assessed by Knowledge about Schizophrenia Test (KAST) 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
Secondary Attitudes of Schizophrenia as assessed by Mental Illness Clinicians' Attitudes Scale (MICA) 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
Secondary Stigma behavior toward Schizophrenia as assessed by Reported and Intended Behavior Scale (RIBS) 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
Secondary Empathy toward Schizophrenia as assessed by Jefferson Scale of Empathy-Health Profession Students (JSE-HPS) 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
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