Condition category
Mental and Behavioural Disorders
Date applied
11/06/2020
Date assigned
18/06/2020
Last edited
19/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Increasing evidence suggests that the stigma associated with mental illness is a powerful barrier to accessing mental health care worldwide. Consistent findings in high-income countries have shown that contact with people with mental illness is the most effective intervention to reduce stigma. However, little evidence is available at present on how to reduce stigma in low- and middle-income countries, including China. The aim of this pilot study is to assess how feasible an intervention to reduce stigma among the primary care and community healthcare staff through a contact-based education intervention.

Who can participate?
Staff from primary care centers, community committees, Civil Affairs, and the China Disabled Persons' Federation in the localities involved in the study: the Haidian District, Chaoyang District, and Fangshan District.

What does the study involve?
Participants will be randomly assigned to either receive a lecture on mental health stigma only or to receive a lecture followed by a session with patients. The lecture will last 1 to 1.5 hours health and patient contact session lasts 1 hour and involves contact with recovery patients with mental illness.

Participants will be interviewed and evaluated by researchers 4 times, each time lasting about 30 minutes. The interview evaluation will discuss background information about participants (such as age) and information on their knowledge, attitude, and behavior about stigma of mental illness and people with mental illness. These evaluations will take place before the lecture, after the lecture/lecture and sesssion, 1 month after intervention, 3 months after intervention.

What are the possible benefits and risks of participating?
A possible benefit of the study is that it will help participants to learn about mental illness and may improve perceptions and understanding of people with mental illness. Participation may also help to develop appropriate strategies for the treatment of stigma surrounding mental illness and improve the lives and survival of people with mental illness and their families.

Discomfort may be caused by the content of the questionnaires completed by the participants. These are stated for the purpose of assessing stigma related to mental illness. If certain items in the scale cause discomfort, participants may refuse to answer.

Where is the study run from?
The study run from Peking University Sixth Hospital (China) and King’s College London (UK).

When is the study starting and how long is it expected to run for?
From November 2016 to March 2019

Who is funding the study?
This study is supported by King’s College London – Peking University Health Science Center Joint Institute for Medical Research.

Who is the main contact?
Dr Wufang Zhang
zhangwufang@bjmu.edu.cn

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wufang Zhang

ORCID ID

http://orcid.org/0000-0003-0221-0012

Contact details

No. 51 Hua Yuan Bei Road
Haidian District
Beijing
100191
China
+86 10 82802834
zhangwufang@bjmu.edu.cn

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ECEIRSCSBC01

Study information

Scientific title

Effect of a contact-based education intervention on reducing stigma among community health and care staff in Beijing, China (ECEIRSCSBC): a pilot randomized controlled study

Acronym

ECEIRSCSBC

Study hypothesis

A contact-based education intervention reduces the stigma associated with mental illness more than a lecture to community health and care staff.

Ethics approval

Approved 07/02/2017, the Peking University Institutional Review Board (Room 501, Yifu Building, Peking University Health Science Center, No 38, Xueyuan Road, Haidian District, Beijing, 100191 China; llwyh@bjmu.edu.cn; +86 10 82805751), ref: IRB00001052-16077

Study design

Double-blind randomized controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to requste a participant information sheet.

Condition

Stigma associated with mental illness

Intervention

Participants had an equal probability of being assigned to the two groups. The coordinator in each site gave a study number to each participant according to the order in which informed consent was obtained. Using a computer-generated randomization a list was compiled through simple randomization, participants were randomly assigned (ratio 1:1) to the control or intervention group.

Those in the control group received the lecture alone without contact, while those in the intervention group were invited also to stay for a session that followed immediately after this, i.e. the contact session.

Participants will complete questionnaires regarding their knowledge, attitudes, and behavior regarding mental health before the lecture and then after either the lecture (control group) or the session (intervention group), and in face-to-face evaluation sessions at 1 and 3 months follow up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Mental health-related knowledge measured using the Mental Health Knowledge Schedule (MAKS) at baseline, immediately after the intervention, and after 1 and 3 months

Secondary outcome measures

1. Mental health-related attitudes measured using The Mental illness: Clinicians’ Attitudes (MICA) at baseline, immediately after the intervention, and after 1 and 3 months
2. Intended behavior measured using the Reported and Intended Behaviour Scale (RIBS) at baseline, immediately after the intervention, and after 1 and 3 months

Overall trial start date

21/11/2016

Overall trial end date

28/03/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Staff from primary care centers, community committees, Civil Affairs, and China Disabled Persons' Federation
2. Aged between 18 and 60 years
3. More than one year of work experience
4. Literate

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

121 participants, 61 in intervention group and 60 in control group.

Total final enrolment

121

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

13/12/2018

Recruitment end date

29/12/2018

Locations

Countries of recruitment

China

Trial participating centre

Zhoukoudian Community Health Service Center
No 28 Zhoukoudian Street Fangshan District
Beijing
102400
China

Trial participating centre

Balizhuang Community Health Service Center
No 11 Yanjingxili Chaoyang District
Beijing
100053
China

Trial participating centre

Shangdi Hospital
No.6, Shucun West Road Nongda South Road Haidian District
Beijing
100084
China

Trial participating centre

Malianwa sub-district office of the Haidian District People's Government
Yard 8, Malianwa Street Haidian District
Beijing
100193
China

Sponsor information

Organisation

Peking University Sixth Hospital

Sponsor details

No. 51 Hua Yuan Bei Road
Haidian District
Beijing
100191
China
+86 10 82802834
liuyuankeban@163.com

Sponsor type

Hospital/treatment centre

Website

http://www.pkuh6.cn/

Funders

Funder type

University/education

Funder name

King’s College London – Peking University Health Science Center Joint Institute for Medical Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to constraints on the data sharing permissions of the samples included in this study, the trialists are not allowed to share the data for public use

Intention to publish date

01/10/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/06/2020: Internal review. 17/06/2020: Trial’s existence confirmed by Peking University Institutional Review Board.