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Stigma, SocialNCT05413408

Intervention to Decrease the Stigma of Nursing Students

A study testing Education and contact in people with Stigma, Social, run by The Hong Kong Polytechnic University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stigma, Social
What is being tested?
Education and contact
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
1 Feb 2023to 1 Jul 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Xiang Ya Hospital of Central South University

    Changsha, Hunan, 410000

    Yuting Zeng, Bachelor

    Recruiting

Other trials in China

About this study

Official title: Chinese Culture-Specific Intervention to Decrease the Stigma of Nursing Students Towards Schizophrenia--A Pilot Randomized Controlled Trial

not

Read the detailed 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).

Conditions
Stigma, Social
Being tested
Education and contact
Medical subject headings
Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education and contactOther

    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.

Study groups in NCT05413408
Study groupRoleWhat they receive
education and contact to change participants stigma towards schizophreniaExperimentalThe 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).
Receives: Other: Education and contact
Participants reading a book about schizophrenia knowledgeActive comparatorThe 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.
Receives: Other: Education and contact

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subject recruitment time

    The time used for subject recruitment

    Measured: up to one month

  2. Achievable recruitment rate

    the ratio between the number of nursing students actually participating and the number of potential nursing students that need to participat

    Measured: up to one month

  3. Eligibility rate of participants

    the number of participants eligible for this study/number of participants screened prior to eligibility assessment.

    Measured: up to one month

  4. The response rate of scales

    the proportions of missing values on the items of each scale

    Measured: up to three month

  5. Drop-out rate of participants

    the number of nursing students who drop out in each intervention session to the number of intervention groups

    Measured: up to three month

Secondary outcomes (4)
  1. 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.

    Measured: up to three month

  2. 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.

    Measured: up to three month

  3. 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.

    Measured: up to three month

  4. 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.

    Measured: up to three month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start1 Feb 2023
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413408
Sponsor's protocol ID
HSEARS20220127002
Status last verified
Mar 2022
First submitted
25 May 2022
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After finish this study

Publications

  • 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.

    PubMed 27822275
  • 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.

    PubMed 32135042
  • Angermeyer MC, Dietrich S. Public beliefs about and attitudes towards people with mental illness: a review of population studies. Acta Psychiatr Scand. 2006 Mar;113(3):163-79. doi: 10.1111/j.1600-0447.2005.00699.x.

    PubMed 16466402
  • Batson, C. D. (2009). These things called empathy: Eight related but distinct phenomena. In J. Decety & W. Ickes (Eds.), The social neuroscience of empathy (pp. 3-15). MIT Press. https://doi.org/10.7551/mitpress/9780262012973.003.0002

  • Batson, C. D., Chang, J., Orr, R., & Rowland, J. (2002). Empathy, Attitudes, and Action: Can Feeling for a Member of a Stigmatized Group Motivate One to Help the Group? Personality and Social Psychology Bulletin, 28(12), 1656-1666. https://doi.org/10.1177/014616702237647

  • Batson, C. D., Early, S., & Salvarani, G. (1997). Perspective Taking: Imagining How Another Feels Versus Imaging How You Would Feel. Personality and Social Psychology Bulletin, 23(7), 751-758. https://doi.org/10.1177/0146167297237008

  • Borrelli B, Sepinwall D, Ernst D, Bellg AJ, Czajkowski S, Breger R, DeFrancesco C, Levesque C, Sharp DL, Ogedegbe G, Resnick B, Orwig D. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol. 2005 Oct;73(5):852-60. doi: 10.1037/0022-006X.73.5.852.

    PubMed 16287385
  • Brouwers EPM. Social stigma is an underestimated contributing factor to unemployment in people with mental illness or mental health issues: position paper and future directions. BMC Psychol. 2020 Apr 21;8(1):36. doi: 10.1186/s40359-020-00399-0.

    PubMed 32317023
  • Chen S, Zhang W, Zhang J. Stigma and schizophrenia. Lancet. 2009 Apr 18;373(9672):1335; author reply 1336-7. doi: 10.1016/S0140-6736(09)60764-9. No abstract available.

    PubMed 19376440
  • Corrigan PW, Morris SB, Michaels PJ, Rafacz JD, Rusch N. Challenging the public stigma of mental illness: a meta-analysis of outcome studies. Psychiatr Serv. 2012 Oct;63(10):963-73. doi: 10.1176/appi.ps.201100529.

    PubMed 23032675
  • Corrigan PW, Rao D. On the self-stigma of mental illness: stages, disclosure, and strategies for change. Can J Psychiatry. 2012 Aug;57(8):464-9. doi: 10.1177/070674371205700804.

    PubMed 22854028
  • Corrigan PW, River LP, Lundin RK, Penn DL, Uphoff-Wasowski K, Campion J, Mathisen J, Gagnon C, Bergman M, Goldstein H, Kubiak MA. Three strategies for changing attributions about severe mental illness. Schizophr Bull. 2001;27(2):187-95. doi: 10.1093/oxfordjournals.schbul.a006865.

    PubMed 11354586
  • Creswell, J. W. (2013). Qualitative Inquiry and Research Design: Choosing among Five Approaches (3rd ed.). SAGE Publications, Inc.

  • Crisp AH, Gelder MG, Rix S, Meltzer HI, Rowlands OJ. Stigmatisation of people with mental illnesses. Br J Psychiatry. 2000 Jul;177:4-7. doi: 10.1192/bjp.177.1.4.

    PubMed 10945080
  • Demiroren, M., Saka, M., Senol, Y., Senturk, V., Baysal, O., & Oztuna, D. (2016). The Impact of Reflective Practices on Medical Students' Attitudes towards Mental Illness. Anatolian Journal of Psychiatry, 17(6), 466. https://doi.org/10.5455/apd.214188

Questions about this trial

What is this clinical trial studying?

A study testing Education and contact in people with Stigma, Social, run by The Hong Kong Polytechnic University at 1 site in China.

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 6 inclusion and 3 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 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Xi CHEN, MSN (+85291203472, 20074345r@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject recruitment time (time frame: up to one month). The study lists 5 primary outcomes in all. 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 NCT05413408, which also lists 51 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 1 Mar 2023.

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