NCT05533177

Brief Summary

WHO has reported the heavy disease burden of psychiatric disorders. Due to the unsatisfactory effect of pharmacotherapy, physical therapy has attracted extensive attention as a complementary therapy. However, few large sample real-world studies are exploring its efficacy. This study intends to explore the efficacy of physical therapy in different types of mental disorders, which is meaningful for the formulation of personalized treatment plans.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

March 26, 2022

Last Update Submit

September 5, 2022

Conditions

Keywords

rTMSbig data analysis

Outcome Measures

Primary Outcomes (5)

  • Times of outpatients visit of patients with different types of mental disorders treated with rTMS

    Based on electronic medical record (text profile), we will extract prognosis related information of patients treated with rTMS, namely, their times of outpatients visit.

    At December 2022

  • Thyroid hormones changes of biochemical parameters after rTMS in patients with mental disorders

    Based on electronic medical record (record of examination information), we will extract all the patients' records of thyroid hormones. Then analyze the changes of these parameters after rTMS to see if these changes are related to the prognosis of patients with mental disorders.

    At March 2023

  • Liver function related indexes changes of biochemical parameters after rTMS in patients with mental

    Base on electronic medical record (record of examination information), we will extract all the patients' records of liver function tests. Then analyze the changes of these parameters after rTMS to see if these changes are related to the prognosis of patients with mental disorders.

    At March 2023

  • Duration of the whole outpatients visit of patients with different types of mental disorders treated with rTMS

    Based on electronic medical record (text profile), we will extract prognosis related information of patients treated with rTMS, namely, the duration of the whole outpatients visit.

    At December 2022

  • Changes of status description of patients with different types of mental disorders treated with rTMS

    Based on electronic medical record (text profile), we will extract prognosis related information of patients treated with rTMS, namely, the changes of status description of disease.

    At December 2022

Study Arms (3)

Schizophrenia, schizotypal and delusional disorders

Patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis of F20-F29 Schizophrenia、schizotypal and delusional disorders criteria and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited.

Mood disorders

Patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis of F30-F39 Mood disorders criteria and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited.

Neurotic, stress-related and somatoform disorders

Patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis of F40-F48 Neurotic、stress-related and somatoform disorders criteria and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis criteria of ICD-10 F20-F48 and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited

You may qualify if:

  • age is not limited
  • gender is not limited
  • meets the diagnostic criteria of ICD-10 F20-F48 and its sub-categories
  • has relevant HIS system data that can be utilized.
  • have been treated with physical therapy

You may not qualify if:

  • patients who did not meet the appeal diagnosis
  • patients who met the above three diagnoses but had severe data loss (missing value ≥ estimated data value of 30%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

  • Yiru Fang

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2022

First Posted

September 8, 2022

Study Start

March 23, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations