Training for schizophrenia patients in the community
| ISRCTN | ISRCTN17333276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17333276 |
| Secondary identifying numbers | 2016c05 |
- Submission date
- 09/08/2020
- Registration date
- 11/08/2020
- Last edited
- 18/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Room 2505
No.1221
XueShi Rd
YinZhou District
Ningbo
315000
China
 ORCID ID |
0000-0001-7186-8593 |
|---|---|
| Phone | +86 (0)57487418723 |
| 47229942@qq.com |
Study information
| Study design | interventional randomized controlled assessor-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | Metacognitive training for schizophrenia patients in the community |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2016 |
| Completion date | 01/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 124 |
| Key inclusion criteria | 1. Age 18-65 2. Diagnosis of schizophrenia in DSM-IV 3. Total PANNS score 50-120 |
| Key exclusion criteria | Psychoactive substances and substance abuse over the last 6 months |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 01/12/2017 |
Locations
Countries of recruitment
- China
Study participating centre
XueShi Rd
YinZhou District
Ningbo
315000
China
Sponsor information
Government
22 Northwest Street
Haishu District
Ningbo
315010
China
| Phone | +86 (0)57487362555 |
|---|---|
| 13777142531@163.com |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 12/08/2020 | No | No | ||
| Results article | results | 13/01/2021 | 15/01/2021 | Yes | No |
Additional files
- ISRCTN17333276_PROTOCOL.pdf
- Uploaded 12/08/2020
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.
