Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

Completed

• Conditions: Mild Traumatic Brain Injury

• Registration Number: NCT02161172
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously. The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome. Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-08
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• 18 ~ 60 years old
• Education: primary school and above, who could understand the content of psychological test
• History of brain trauma
• No taking of antipsychotic or any other drugs affecting central nervous system before the test
• Glasgow coma score (GCS) was 13-15

Exclusion Criteria

• History of craniocerebral injury, brain disease, mental disease
• With mental retardation
• with other serious body diseases
• History of drug and alcohol dependence
• With color-blind or color weakness
• Who had severe visual and auditory disorders after brain injury
• Who failed or failed in completing the test effectively
• With cognitive impairment caused by the damage of the unilateral frontal or bilateral lobes, or with language dysfunction caused by temporal lobe damage

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mini-Mental State Examination	6 months	MMSE includes seven factors, namely: the time orientation factor (5 points), place orientation (5 points), immediate memory (3 points), short-term memory (3 points), calculation capabilities (5 points), verbal expression, naming and repetition (4 points), speech reading and understanding (4 points), graphic depiction (1 points). The scales for the description of cognitive function impairment were grouped into three levels of education: illiteracy (17 points), primary school (20 points) and middle school (24 points). The one with score below average was considered with cognitive function impairment.

Secondary Outcome Measures

Name	Time	Method
Activity of daily living scale	6 months	The scale is divided into two parts: physical self-care ability, instrumental activities of daily living. 1 point for each option means normal; If 2\~4 points for one option, he or she probably had ability decline; If two or more parts ≥3 points or total score≥ 22 points (14 questions), he or she exhibited living ability decline clearly.

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China