Condition category
Mental and Behavioural Disorders
Date applied
09/08/2020
Date assigned
11/08/2020
Last edited
18/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms. The traditional general practitioner-based model (community-based rehabilitation [CBR]) for schizophrenia patients in China, lacks content-rich, useful, and theoretically-based rehabilitation means. However, according to previous research, Metacognitive Training (MCT) may be effective in the community for schizophrenic patients. The present study aims to compare a combined intervention consisting of MCT and CBR with the control group receiving CBR only.

Who can participate?
Patients aged 18-65 with schizophrenia

What does the study involve?
Participants are randomly allocated to the intervention group or the control group. The intervention group receives CBR plus Metacognitive Training (MCT) The MCT consists of 8 modules, each session lasts about 60 minutes, and the whole course lasts for 8 weeks, and a gift worth $5 is given to the patient after each session. The control group receives a standard CBR in China for mental illness patients for 8 weeks. GPs first work with patients and their respective families to develop an individualized rehabilitation plan in the first week and then follow up once during the project in the form of a phone call or home visits. The total duration of the intervention is 8 weeks, and 1 week for the follow-up.

What are the possible benefits and risks of participating?
The course may improve the delusions of the patients.

Where is the study run from?
Ningbo Yinzhou District Center for Disease Control and Prevention (China)

When is the study starting and how long is it expected to run for?
August 2016 to December 2018

Who is funding the study?
Ningbo Medical Science and Technology Plan Project (China)

Who is the main contact?
Dr Qi Chen
47229942@qq.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Qi Chen

ORCID ID

http://orcid.org/0000-0001-7186-8593

Contact details

Room 2505
No.1221
XueShi Rd
YinZhou District
Ningbo
315000
China
+86 (0)57487418723
47229942@qq.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2016c05

Study information

Scientific title

Metacognitive training for schizophrenia patients in the community

Acronym

Study hypothesis

The present study aims to compare a combined intervention consisting of MCT and CBR with the control group receiving CBR only. The study goes further to confirm the superiority of MCT over CBR for the improvement of delusion. Thus, decreasing the possibilities of violent acts committed by these patients in the community. The researchers also expect some aspects of the quality of life of these schizophrenic patients to improve. Finally, to find evidence of MCT feasibility on community rehabilitation, and for the government to tailor the community services by taking the MCT as a regular complement strategy to the CBR.

Ethics approval

Approved 20/11/2016, YinZhou Center for Disease Control and Prevention’s Research Ethics Board (No.1221, XueShi Rd, YinZhou District, Ningbo, China; +86 (0)57487418723; yzcdcreb@163.com), ref: 2016-11

Study design

interventional randomized controlled assessor-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Schizophrenia

Intervention

The researchers use a completely random method for grouping. First, they number the subjects according to the order in which they are recruited. Then, they use the random number table method to give each subject a random number in sequence. Finally, they sort the subjects by the size of random numbers. They assign the first 60 cases to the intervention group, and the latter 60 cases to the control.

The intervention group receives CBR plus Metacognitive Training (MCT), Chinese ver.6.2 (see https://clinical-neuropsychology.de/metakognitives_training_psychose/). The MCT consists of 8 modules, which covers six cognitive and social biases (attribution biases, jumping to conclusions, belief inflexibility, overconfidence in errors, the theory of mind deficits, and depressive cognitive schemata). Each session lasts about 60 minutes, and the whole course lasts for 8 weeks, and a gift worth $5 is given to the patient after each session.

The control group receives a standard CBR in China for mental illness patients (see http://www.gov.cn/gongbao/content/2018/content_5338247.htm) for 8 weeks. GPs first work with patients and their respective families to develop an individualized rehabilitation plan at the first week and then follow up once during the project in the form of a phone call or home visits. The rehabilitation plan in CBR consists of six aspects, including medication training, relapse identification, physical management, life skills training, social skills training, and occupational rehabilitation training etc.

The total duration of the intervention is 8 weeks, and 1 week for the follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Symptom severity of delusion assessed with the Positive and Negative Syndrome Scale (PANSS) and Psychotic Symptom Rating Scales (PSYRATS) at baseline and the end of the intervention (8 weeks)

Secondary outcome measures

Quality of life measured using Schizophrenia Quality of Life Scale (SQLS) at baseline and the end of the intervention (8 weeks)

Overall trial start date

01/08/2016

Overall trial end date

01/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age 18-65
2. Diagnosis of schizophrenia in DSM-IV
3. Total PANNS score 50-120

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Total final enrolment

124

Participant exclusion criteria

Psychoactive substances and substance abuse over the last 6 months

Recruitment start date

01/01/2017

Recruitment end date

01/12/2017

Locations

Countries of recruitment

China

Trial participating centre

Ningbo Yinzhou District Center for Disease Control and Prevention
No.1221 XueShi Rd YinZhou District
Ningbo
315000
China

Sponsor information

Organisation

Ningbo Municipal Health Bureau

Sponsor details

22 Northwest Street
Haishu District
Ningbo
315010
China
+86 (0)57487362555
13777142531@163.com

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Ningbo Medical Science and Technology Plan Project (2016C05)

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
Since the survey subjects are schizophrenic patients, most of the patients signed a privacy protection agreement before the project started in order to protect their privacy. However, the researchers can still provide the original questionnaire records and database of some patients when necessary. Dr Lifang Ren (13777142531@163.com) would be contacted for access to the datasets. The type of data can be Excel or others. The data will become available after 01/12/2020 for 1 year. Data requesters need to apply to Ningbo Municipal Health Bureau and Yinzhou District Center for Disease Control and Prevention, and submit data analysis plans only for scientific usage. Consent from all the participants was obtained and all consent documents have been sealed according to the requirements of project file management, and can be inquired whenever needed.

Intention to publish date

01/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

2021 results in https://pubmed.ncbi.nlm.nih.gov/33441093/ (added 15/01/2021)

Publication citations

Additional files

Editorial Notes

18/01/2021; Internal review. 15/01/2021: Publication reference added. 12/08/2020: Uploaded protocol (not peer reviewed). 11/08/2020: Trial's existence confirmed by YinZhou Center for Disease Control and Prevention’s Research Ethics Board.