Intervention to Decrease the Stigma of Nursing Students

February 27, 2023 updated by: The Hong Kong Polytechnic University

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

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Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Hu Nan
      • Changsha, Hu Nan, China, 410000
        • Recruiting
        • Xiang Ya Hospital of Central South University
        • Contact:
          • Yuting Zeng, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

March 1, 2022

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)?

NO

IPD Plan Description

After finish this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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