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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| education and contact to change participants stigma towards schizophrenia | Experimental | 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). |
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| Participants reading a book about schizophrenia knowledge | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and contact | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject recruitment time | The time used for subject recruitment | up to one month |
| 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 |
| Eligibility rate of participants | 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 | the proportions of missing values on the items of each scale | up to three month |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi CHEN, MSN | Contact | +85291203472 | 20074345r@connect.polyu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiang Ya Hospital of Central South University | Recruiting | Changsha | Hunan | 410000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27822275 | Background | Amini H, Shoar S, Tabatabaee M, Arabzadeh S. The Effect of Clinical Exposure to Patients on Medical Students' Attitude Towards Mental Illness. Iran J Psychiatry Behav Sci. 2016 May 10;10(3):e1887. doi: 10.17795/ijpbs-1887. eCollection 2016 Sep. | |
| 32135042 | Background | Amsalem D, Gothelf D, Dorman A, Goren Y, Tene O, Shelef A, Horowitz I, Dunsky LL, Rogev E, Klein EH, Mekori-Domachevsky E, Fischel T, Levkovitz Y, Martin A, Gross R. Reducing Stigma Toward Psychiatry Among Medical Students: A Multicenter Controlled Trial. Prim Care Companion CNS Disord. 2020 Feb 27;22(2):19m02527. doi: 10.4088/PCC.19m02527. |
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After finish this study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2022 | Jun 7, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| up to three month |
| 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 |
| 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 |
| 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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